"REMSID","REMS_Name","Version_ID","Version_Date","Material_ID","Material_Name","Material_Link" "2","Adasuve","21","12/21/2012","1","Adasuve Education Program","" "2","Adasuve","21","12/21/2012","2","Adasuve REMS website (www.adasuverems.com)","" "2","Adasuve","21","12/21/2012","3","Dear Healthcare Professional Letter","" "2","Adasuve","21","12/21/2012","4","Healthcare Facility Enrollment Information and Form","" "2","Adasuve","21","12/21/2012","5","Healthcare Provider Brochure","" "2","Adasuve","21","12/21/2012","6","Order Set / Protocol Template","" "2","Adasuve","21","12/21/2012","7","Steps for Safe Use of Adasuve","" "2","Adasuve","21","12/21/2012","8","Wholesaler/Distributor Enrollment Form","" "6","Aranesp","34","03/27/2013","9","Dear Healthcare Provider Letter","" "6","Aranesp","34","03/27/2013","10","Dear Hospital Administrator Letter","" "6","Aranesp","34","03/27/2013","11","Enrollment Form for Healthcare Providers","" "6","Aranesp","34","03/27/2013","12","Enrollment Form for Hospitals","" "6","Aranesp","34","03/27/2013","13","ESA REMS Flashcard","" "6","Aranesp","34","03/27/2013","14","Guidelines for Patient Acknowledgment Form Integration","" "6","Aranesp","34","03/27/2013","15","HCP Program Starter Kit","" "6","Aranesp","34","03/27/2013","16","Healthcare Provider Flashcard","" "6","Aranesp","34","03/27/2013","17","Hospital Process Overview Flashcard","" "6","Aranesp","34","03/27/2013","18","Medication Guide","" "6","Aranesp","34","03/27/2013","19","Patient and Healthcare Professional Acknowledgment Form","" "6","Aranesp","34","03/27/2013","20","Training Module for Healthcare Providers","" "6","Aranesp","34","03/27/2013","21","Training Module for Hospital Designees","" "6","Aranesp","34","03/27/2013","22","Website","" "6","Aranesp","34","03/27/2013","23","Website - Home Page","" "6","Aranesp","34","03/27/2013","24","Website - Important Safety Information","" "6","Aranesp","34","03/27/2013","25","Website - Other Web Pages","" "6","Aranesp","34","03/27/2013","26","Website - Program Overview","" "6","Aranesp","34","03/27/2013","27","Website - Training Modules and Enrollment Forms","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","28","Appropriate Use Checklist","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","29","BTOD REMS Website","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","30","Dear Pharmacist Letter","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","31","Dear Prescriber Letter","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","32","Pharmacist Brochure","" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","33","Prescriber Brochure","" "11","Caprelsa","41","06/22/2011","34","CAPRELSA Pharmacy Enrollment Form","" "11","Caprelsa","41","06/22/2011","35","Dear Health Care Provider Letter","" "11","Caprelsa","41","06/22/2011","36","Dear Medical Society Letter","" "11","Caprelsa","41","06/22/2011","37","HCP Education Pamphlet","" "11","Caprelsa","41","06/22/2011","38","HCP Education slides set","" "11","Caprelsa","41","06/22/2011","39","Medication Guide","" "11","Caprelsa","41","06/22/2011","40","Prescriber Enrollment Form","" "11","Caprelsa","41","06/22/2011","41","Prescriber Training Program","" "15","Entereg","49","09/25/2012","42","Dear Hospital Pharmacist Letter","" "15","Entereg","49","09/25/2012","43","E.A.S.E. Kit Folder","" "15","Entereg","49","09/25/2012","44","Hospital Brochure","" "15","Entereg","49","09/25/2012","45","Hospital Registration Form","" "15","Entereg","49","09/25/2012","46","Prescribing Information Brochure","" "15","Entereg","49","09/25/2012","47","Professional Labeling","" "15","Entereg","49","09/25/2012","48","Program Overview","" "15","Entereg","49","09/25/2012","49","VA Medical Center Registration Form","" "16","Epogen / Procrit","53","03/27/2013","50","Dear Healthcare Provider Letter","" "16","Epogen / Procrit","53","03/27/2013","51","Dear Hospital Administrator Letter","" "16","Epogen / Procrit","53","03/27/2013","52","Enrollment Form for Healthcare Providers","" "16","Epogen / Procrit","53","03/27/2013","53","Enrollment Form for Hospitals","" "16","Epogen / Procrit","53","03/27/2013","54","ESA REMS Flashcard","" "16","Epogen / Procrit","53","03/27/2013","55","Guidelines for Patient Acknowledgment Form Integration","" "16","Epogen / Procrit","53","03/27/2013","56","HCP Program Starter Kit","" "16","Epogen / Procrit","53","03/27/2013","57","Healthcare Provider Flashcard","" "16","Epogen / Procrit","53","03/27/2013","58","Hospital Process Overview Flashcard","" "16","Epogen / Procrit","53","03/27/2013","59","Medication Guides","" "16","Epogen / Procrit","53","03/27/2013","60","Patient and Healthcare Professional Acknowledgment Form","" "16","Epogen / Procrit","53","03/27/2013","61","Training Module for Healthcare Providers","" "16","Epogen / Procrit","53","03/27/2013","62","Training Module for Hospital Designees","" "16","Epogen / Procrit","53","03/27/2013","63","Website","" "17","Opioid Analgesic REMS","171","04/15/2013","64","ER/LA Opioid Analgesic REMS Website","" "17","Opioid Analgesic REMS","171","04/15/2013","65","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","" "17","Opioid Analgesic REMS","171","04/15/2013","66","Medication Guide","" "17","Opioid Analgesic REMS","171","04/15/2013","67","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","" "17","Opioid Analgesic REMS","171","04/15/2013","68","Prescriber Letter 1","" "17","Opioid Analgesic REMS","171","04/15/2013","69","Prescriber Letter 2","" "17","Opioid Analgesic REMS","171","04/15/2013","70","Prescriber Letter 3","" "17","Opioid Analgesic REMS","171","04/15/2013","71","Professional Organization/Licensing Board Letter 1","" "17","Opioid Analgesic REMS","171","04/15/2013","72","Professional Organization/Licensing Board Letter 2","" "18","Extraneal","54","03/09/2011","73","Bracelet","" "18","Extraneal","54","03/09/2011","74","Chart Sticker","" "18","Extraneal","54","03/09/2011","75","Dear Patient Letter","" "18","Extraneal","54","03/09/2011","76","Extraneal Patient Kit","" "18","Extraneal","54","03/09/2011","77","Extraneal Patient Training Tool","" "18","Extraneal","54","03/09/2011","78","Extraneal PD Nurse Training Tool","" "18","Extraneal","54","03/09/2011","79","Letter to hospital admissions staff","" "18","Extraneal","54","03/09/2011","80","Letter to hospital nurse","" "18","Extraneal","54","03/09/2011","81","Letter to hospital pharmacy","" "18","Extraneal","54","03/09/2011","82","Letter to hospital physician","" "18","Extraneal","54","03/09/2011","83","Letter to laboratory services","" "18","Extraneal","54","03/09/2011","84","Magnetic Hang Tag","" "18","Extraneal","54","03/09/2011","85","Medication Guide","" "18","Extraneal","54","03/09/2011","86","Pendant","" "18","Extraneal","54","03/09/2011","87","Wallet Card","" "21","Gattex","58","12/21/2012","88","Dear Healthcare Professional Letter","" "21","Gattex","58","12/21/2012","89","Dear Professional Society Letter","" "21","Gattex","58","12/21/2012","90","Gattex REMS Website Screenshots","" "21","Gattex","58","12/21/2012","91","Patient and Caregiver Counseling Guide","" "21","Gattex","58","12/21/2012","92","Prescriber Education Slide Deck","" "24","Isotretinoin iPLEDGE","172","10/22/2010","93","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin.","" "24","Isotretinoin iPLEDGE","172","10/22/2010","94","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","" "24","Isotretinoin iPLEDGE","172","10/22/2010","95","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","" "24","Isotretinoin iPLEDGE","172","10/22/2010","96","Instructions for Managing Office Staff Designees","" "24","Isotretinoin iPLEDGE","172","10/22/2010","97","iPLEDGE website Pharmacy web pages","" "24","Isotretinoin iPLEDGE","172","10/22/2010","98","iPLEDGE website Prescriber web pages","" "24","Isotretinoin iPLEDGE","172","10/22/2010","99","iPLEDGE wholesaler agreement","" "24","Isotretinoin iPLEDGE","172","10/22/2010","100","ipledgeprogram.com home page","" "24","Isotretinoin iPLEDGE","172","10/22/2010","101","Isotretinoin Educational Kit for Females of Childbearing Potential","" "24","Isotretinoin iPLEDGE","172","10/22/2010","102","Isotretinoin Educational Kit for Males and Females of Nonchildbearing Potential","" "24","Isotretinoin iPLEDGE","172","10/22/2010","103","Medication Guide","" "24","Isotretinoin iPLEDGE","172","10/22/2010","104","Non-Compliance Action Policy","" "24","Isotretinoin iPLEDGE","172","10/22/2010","105","Office Staff Designee Registration/Activation Form","" "24","Isotretinoin iPLEDGE","172","10/22/2010","106","Patient Information/Informed Consent for all patients","" "24","Isotretinoin iPLEDGE","172","10/22/2010","107","Patient Information/Informed Consent for Female Patients who Can Get Pregnant","" "24","Isotretinoin iPLEDGE","172","10/22/2010","108","Patient Monthly Comprehension Questions","" "24","Isotretinoin iPLEDGE","172","10/22/2010","109","Pharmacist Guide for the iPLEDGE Program","" "24","Isotretinoin iPLEDGE","172","10/22/2010","110","Pharmacy Registration Form","" "24","Isotretinoin iPLEDGE","172","10/22/2010","111","Prescriber Contraception Counseling Guide","" "24","Isotretinoin iPLEDGE","172","10/22/2010","112","Prescriber Registration Form","" "24","Isotretinoin iPLEDGE","172","10/22/2010","113","Recognizing Psychiatric Disorders In Adolescents And Young Adults","" "24","Isotretinoin iPLEDGE","172","10/22/2010","114","Request for Exemption for Patients with Serious Medical Reasons","" "24","Isotretinoin iPLEDGE","172","10/22/2010","115","The Guide to Best Practices For the iPLEDGE Program","" "24","Isotretinoin iPLEDGE","172","10/22/2010","116","The iPLEDGE Program Patient Introductory Brochure","" "24","Isotretinoin iPLEDGE","172","10/22/2010","117","Wholesaler to wholesaler shipment request form","" "25","Juxtapid","62","12/21/2012","118","Dear Healthcare Provider Letter","" "25","Juxtapid","62","12/21/2012","119","Dear Professional Society Letter","" "25","Juxtapid","62","12/21/2012","120","Prescriber Enrollment Form","" "25","Juxtapid","62","12/21/2012","121","Prescriber Training Module","" "25","Juxtapid","62","12/21/2012","122","Prescription Authorization Form","" "25","Juxtapid","62","12/21/2012","123","Website","" "27","Kynamro","66","01/29/2013","124","Dear Healthcare Provider Letter","" "27","Kynamro","66","01/29/2013","125","Dear Professional Association Letter","" "27","Kynamro","66","01/29/2013","126","Healthcare Professional Information Brochure","" "27","Kynamro","66","01/29/2013","127","Prescriber Enrollment Form","" "27","Kynamro","66","01/29/2013","128","Prescriber Training Slide Set","" "27","Kynamro","66","01/29/2013","129","Prescription Authorization Form","" "27","Kynamro","66","01/29/2013","130","Summary of Monitoring Recommendations","" "27","Kynamro","66","01/29/2013","131","Website","" "27","Kynamro","66","01/29/2013","132","Website - Landing Page","" "28","Letairis","74","10/19/2012","133","Medication Guide","" "28","Letairis","74","10/19/2012","134","Patient Enrollment and Consent Forms","" "28","Letairis","74","10/19/2012","135","Patient Enrollment Guide","" "28","Letairis","74","10/19/2012","136","Patient Re-enrollment Form","" "28","Letairis","74","10/19/2012","137","Prescriber Enrollment and Agreement Form","" "28","Letairis","74","10/19/2012","138","Prescriber Guide: Letairis and the LEAP Program","" "28","Letairis","74","10/19/2012","139","Prescriber Supplemental Education Materials: Ongoing Education Program Form","" "28","Letairis","74","10/19/2012","140","Website","" "29","Lotronex","75","09/02/2010","141","Educational Mailing: Important Information for Pharmacists","" "29","Lotronex","75","09/02/2010","142","Lotronex Website "for Patients" Section","" "29","Lotronex","75","09/02/2010","143","LOTRONEXPPL Website "For Pharmacists" Section","" "29","Lotronex","75","09/02/2010","144","LotronexPPL Website "For Prescriber" section","" "29","Lotronex","75","09/02/2010","145","Medication Guide","" "29","Lotronex","75","09/02/2010","146","Patient Acknowledgment Form","" "29","Lotronex","75","09/02/2010","147","Patient Follow-Up Survey Pre-Enrollment Form","" "29","Lotronex","75","09/02/2010","148","Prescriber Enrollment Letter","" "29","Lotronex","75","09/02/2010","149","PPL Kit","" "29","Lotronex","75","09/02/2010","150","PPL Kit Overview Letter","" "29","Lotronex","75","09/02/2010","151","PPL Pharmacist Education Slide Deck","" "29","Lotronex","75","09/02/2010","152","PPL Prescriber Education Slide Deck","" "29","Lotronex","75","09/02/2010","153","PPL Stickers Instructions for Pharmacists","" "29","Lotronex","75","09/02/2010","154","PPL stickers","" "29","Lotronex","75","09/02/2010","155","Prescriber Enrollment Form","" "29","Lotronex","75","09/02/2010","156","Prescribing Information","" "30","Lumizyme","78","07/16/2012","157","Healthcare Facility Enrollment and Attestation Form","" "30","Lumizyme","78","07/16/2012","158","Training and Certification for HCPs","" "30","Lumizyme","78","07/16/2012","159","Lumizyme ACE Program: Information for HCPs","" "30","Lumizyme","78","07/16/2012","160","Lumizyme Healthcare Professional Introductory Letter","" "30","Lumizyme","78","07/16/2012","161","Lumizyme Infusion Confirmation Form","" "30","Lumizyme","78","07/16/2012","162","Lumizyme Prescriber Introductory Letter","" "30","Lumizyme","78","07/16/2012","163","Patient Enrollment and Acknowledgment Form","" "30","Lumizyme","78","07/16/2012","164","Prescriber Enrollment and Attestation Form","" "35","Mifeprex","83","06/08/2011","166","Patient Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_PATIENT AGREEMENT.pdf" "35","Mifeprex","83","06/08/2011","167","Prescriber's Agreement and Account Setup Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_PRESCRIBERS AGREEMENT.pdf" "37","Mycophenolate","173","09/25/2012","168","Center Training Confirmation Form","" "37","Mycophenolate","173","09/25/2012","169","DHCP Introductory Letter","" "37","Mycophenolate","173","09/25/2012","170","DHCP Letter for Centers","" "37","Mycophenolate","173","09/25/2012","171","Journal Information Piece","" "37","Mycophenolate","173","09/25/2012","172","Medication Guide","" "37","Mycophenolate","173","09/25/2012","173","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","" "37","Mycophenolate","173","09/25/2012","174","Mycophenolate REMS Brochure for Healthcare Providers","" "37","Mycophenolate","173","09/25/2012","175","Mycophenolate REMS Overview for Patients and Your Birth Control Options","" "37","Mycophenolate","173","09/25/2012","176","Mycophenolate REMS Website","" "37","Mycophenolate","173","09/25/2012","177","Obstetrician/Gynecologist Referral Template Letters for Contraception Counseling","" "37","Mycophenolate","173","09/25/2012","178","Obstetrician/Gynecologist Referral Template Letters for Preconception Counseling","" "37","Mycophenolate","173","09/25/2012","179","Patient-Prescriber Acknowledgement Form","" "37","Mycophenolate","173","09/25/2012","180","Prescriber Training Confirmation Form","" "41","Pomalyst","96","02/08/2013","181","Prescriber Enrollment Form","" "41","Pomalyst","96","02/08/2013","182","Patient Prescription Form","" "41","Pomalyst","96","02/08/2013","183","Patient Prescription Form (Veterans Administration)","" "41","Pomalyst","96","02/08/2013","184","Prescriber Guide to POMALYST REMS program","" "41","Pomalyst","96","02/08/2013","185","POMALYST REMS™ At-A-Glance","" "41","Pomalyst","96","02/08/2013","186","Welcome Letter","" "41","Pomalyst","96","02/08/2013","187","CelgeneRiskManagement.com website screenshot","" "41","Pomalyst","96","02/08/2013","188","Pharmacy Guide to the POMALYST REMS Program","" "41","Pomalyst","96","02/08/2013","189","Education and Counseling Checklist for Pharmacies","" "41","Pomalyst","96","02/08/2013","190","Celgene REMS Programs Pharmacy Training: the POMALYST REMS Program","" "41","Pomalyst","96","02/08/2013","191","Pharmacy Certification Quiz","" "41","Pomalyst","96","02/08/2013","192","Patient-Physician Agreement Form for Adult Male","" "41","Pomalyst","96","02/08/2013","193","Patient-Physician Agreement Form for Male Child","" "41","Pomalyst","96","02/08/2013","194","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","" "41","Pomalyst","96","02/08/2013","195","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","" "41","Pomalyst","96","02/08/2013","196","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","" "41","Pomalyst","96","02/08/2013","197","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","" "41","Pomalyst","96","02/08/2013","198","Patient Guide to POMALYST REMS program","" "41","Pomalyst","96","02/08/2013","199","Emergency Contraception Brochure","" "41","Pomalyst","96","02/08/2013","200","Patient Survey Reminder Card","" "41","Pomalyst","96","02/08/2013","201","POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program education and prescribing safety kit","" "41","Pomalyst","96","02/08/2013","202","POMALYST REMS™ Patient Resource Pack Envelope","" "41","Pomalyst","96","02/08/2013","203","POMALYST Pregnancy Exposure Registry Protocol, including letter and questionnaires","" "45","Qsymia","108","04/16/2013","204","Risk of Birth Defects with Qsymia patient brochure","" "45","Qsymia","108","04/16/2013","205","Healthcare Provider Counseling Tool for Females of Reproductive Potential","" "45","Qsymia","108","04/16/2013","206","Prescriber Dosing and Management Checklist","" "45","Qsymia","108","04/16/2013","207","Online Qsymia REMS training","" "45","Qsymia","108","04/16/2013","208","Print Qsymia REMS training","" "45","Qsymia","108","04/16/2013","209","Dear Healthcare Provider letter","" "45","Qsymia","108","04/16/2013","210","Dear Medical Society letter","" "45","Qsymia","108","04/16/2013","211","Pharmacy Enrollment Form, Independent Pharmacy","" "45","Qsymia","108","04/16/2013","212","Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy","" "45","Qsymia","108","04/16/2013","213","Pharmacy Enrollment Form, Mail Order Pharmacy","" "45","Qsymia","108","04/16/2013","214","Online Qsymia REMS Pharmacy Training module","" "45","Qsymia","108","04/16/2013","215","Print Qsymia REMS Pharmacy Training module","" "45","Qsymia","108","04/16/2013","216","Medication Guide","" "46","Revlimid","111","02/08/2013","217","Education and Counseling Checklist for Pharmacies","" "46","Revlimid","111","02/08/2013","218","Patient Guide","" "46","Revlimid","111","02/08/2013","219","Patient-Physician Agreement Form - Adult Male","" "46","Revlimid","111","02/08/2013","220","Patient-Physician Agreement Form - Female Child Who Can Not Get Pregnant","" "46","Revlimid","111","02/08/2013","221","Patient-Physician Agreement Form - Female Child Who Can Get Pregnant","" "46","Revlimid","111","02/08/2013","222","Patient-Physician Agreement Form - Adult Female Who Can Not Get Pregant","" "46","Revlimid","111","02/08/2013","223","Patient-Physician Agreement Form - Adult Female Who Can Get Pregnant","" "46","Revlimid","111","02/08/2013","224","Patient Registration and Patient-Physician Agreement Form for Male Child","" "46","Revlimid","111","02/08/2013","225","Prescriber Quick Reference Guide","" "46","Revlimid","111","02/08/2013","226","Prescriber_Enrollment_Form","" "46","Revlimid","111","02/08/2013","227","Revlimid REMS at a Glance","" "46","Revlimid","111","02/08/2013","228","Prescriber Materials Letter","" "46","Revlimid","111","02/08/2013","229","Patient Resource Pack","" "46","Revlimid","111","02/08/2013","230","Prescriber Guide","" "46","Revlimid","111","02/08/2013","231","REVLIMID Pregancy Exposure Registry Protocol, including letter and questionnaires","" "47","Rosiglitazone","174","01/25/2013","232","Medication Guide","" "47","Rosiglitazone","174","01/25/2013","233","Patient Enrollment Form","" "47","Rosiglitazone","174","01/25/2013","234","Prescriber Enrollment Form","" "47","Rosiglitazone","174","01/25/2013","235","Prescriber Overview","" "47","Rosiglitazone","174","01/25/2013","236","VA Patient Enrollment Form","" "48","Sabril","115","12/11/2012","237","Dear HCP Medication Taper letter","" "48","Sabril","115","12/11/2012","238","Dear Healthcare Professional Letter","" "48","Sabril","115","12/11/2012","239","Medication Guide","" "48","Sabril","115","12/11/2012","240","Ophthalmologic Assessment Form","" "48","Sabril","115","12/11/2012","241","Patient/Parent/Legal Guardian - Physician Agreement","" "48","Sabril","115","12/11/2012","242","Prescriber Enrollment and Agreement Form","" "48","Sabril","115","12/11/2012","243","Treatment Initiation Form","" "48","Sabril","115","12/11/2012","244","Treatment Maintenance Form","" "49","Soliris","117","09/23/2011","245","Dosing and Administration Guide","" "49","Soliris","117","09/23/2011","246","Medication Guide","" "49","Soliris","117","09/23/2011","247","Patient Safety Brochure, Important Safety Information about Soliris","" "49","Soliris","117","09/23/2011","248","Prescriber Introductory Letter and Enrollment Form","" "49","Soliris","117","09/23/2011","249","Prescriber Safety Brochure, Important Safety Information about Soliris","" "49","Soliris","117","09/23/2011","250","Soliris Patient Safety Card","" "52","Suboxone sublingual film","123","08/30/2010","251","Medication Guide","" "52","Suboxone sublingual film","123","08/30/2010","252","REMS Instruction Letter to Prescribers","" "52","Suboxone sublingual film","123","08/30/2010","253","REMS Introductory Letter to Pharmacists","" "52","Suboxone sublingual film","123","08/30/2010","254","Appropriate Use Checklist","" "52","Suboxone sublingual film","123","08/30/2010","255","Physician Brochure","" "52","Suboxone sublingual film","123","08/30/2010","256","Pharmacist Brochure","" "58","Thalomid","135","02/08/2013","257","Prescriber Guide to THALOMID REMS Program","" "58","Thalomid","135","02/08/2013","258","Thalomid REMS at a Glance","" "58","Thalomid","135","02/08/2013","259","Prescriber Enrollment Form","" "58","Thalomid","135","02/08/2013","260","Patient-Physician Agreement Form - Adult Female Who Can Get Pregnant","" "58","Thalomid","135","02/08/2013","261","Patient-Physician Agreement Form - Adult Female Who Can Not Get Pregnant","" "58","Thalomid","135","02/08/2013","262","Patient-Physician Agreement Form - Female Child Who Can Get Pregnant","" "58","Thalomid","135","02/08/2013","263","Patient-Physician Agreement Form - Adult Male","" "58","Thalomid","135","02/08/2013","264","Patient-Physician Agreement Form - Female Child Who Can Not Get Pregnant","" "58","Thalomid","135","02/08/2013","265","Patient-Physician Agreement Form - Male Child","" "58","Thalomid","135","02/08/2013","266","Education and Prescribing Safety Kit","" "58","Thalomid","135","02/08/2013","267","Welcome Letter","" "58","Thalomid","135","02/08/2013","268","Pharmacy Guide to the THALOMID REMS Program","" "58","Thalomid","135","02/08/2013","269","Pharmacy Enrollment Form","" "58","Thalomid","135","02/08/2013","270","Patient Resource Pack","" "58","Thalomid","135","02/08/2013","271","Patient Guide to THALOMID REMS program","" "58","Thalomid","135","02/08/2013","272","Patient Survey Reminder","" "58","Thalomid","135","02/08/2013","273","CelgeneRiskManagement.com website","" "58","Thalomid","135","02/08/2013","274","THALOMID Pregancy Exposure Registry Protocol, including letter and questionnaires","" "58","Thalomid","135","02/08/2013","275","Emergency Contraception Brochure","" "59","Tikosyn","136","07/11/2011","276","Dear Healthcare Provider Letter for new enrollees","" "59","Tikosyn","136","07/11/2011","277","Dear Healthcare Provider Letter for re-certification","" "59","Tikosyn","136","07/11/2011","278","Dear Pharmacist Letter for new enrollees - Pharmacies","" "59","Tikosyn","136","07/11/2011","279","Dear Pharmacist Letter for re-certification - Pharmacies","" "59","Tikosyn","136","07/11/2011","280","Institution Certification Form","" "59","Tikosyn","136","07/11/2011","281","Medication Guide","" "59","Tikosyn","136","07/11/2011","282","Pharmacy Certification Form","" "59","Tikosyn","136","07/11/2011","283","Prescriber Certification Form","" "59","Tikosyn","136","07/11/2011","284","T.I.P.S._Procedures_Booklet","" "59","Tikosyn","136","07/11/2011","285","Tikosyn Treatment Guidelines","" "59","Tikosyn","136","07/11/2011","286","Tikosyn REMS Website","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","287","(Product-Specific TIRF) Medication Guide","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","288","Chain Pharmacy Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","289","Closed System Pharmacy Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","290","Dear Distributor Letter","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","291","Dear Healthcare Provider Letter","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","292","Dear Inpatient Pharmacy Letter","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","293","Dear Outpatient Pharmacy Letter","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","294","Wholesaler Distributor Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","295","Frequently Asked Questions (FAQs)","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","296","Inpatient Pharmacy Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","297","Outpatient Pharmacy Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","298","Patient-Prescriber Agreement Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","299","Education Program","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","300","Knowledge Assessment","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","301","Prescriber Enrollment Form","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","302","TIRF REMS Access Program Overview (Outpatient)","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","303","TIRF REMS Access Program Overview (Prescribers)","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","304","TIRF REMS Access Website","" "61","Tracleer","139","10/02/2012","305","FRM 549-COP-US, Request for >30-Day Supply","" "61","Tracleer","139","10/02/2012","306","Medication Guide","" "61","Tracleer","139","10/02/2012","307","Patient Essentials Guide","" "61","Tracleer","139","10/02/2012","308","Patient Information Sheet (to be provided to the patient by the certified pharmacy)","" "61","Tracleer","139","10/02/2012","309","Prescriber Essentials guide","" "61","Tracleer","139","10/02/2012","310","Prescriber letter","" "61","Tracleer","139","10/02/2012","311","Prescriber letter from certified pharmacy (accompanies FRM-549-COP-US)","" "61","Tracleer","139","10/02/2012","312","Enrollment and Renewal Form","" "62","Truvada","140","07/16/2012","313","Agreement Form for Initiating TRUVADA for Pre-Exposure Prophylaxis of Sexually Acquired HIV-1 Infection for an uninfected individual taking TRUVADA for a PrEP Indication","" "62","Truvada","140","07/16/2012","314","Checklist for Prescribers to manage an individual considering or taking TRUVADA for a PrEP indication","" "62","Truvada","140","07/16/2012","315","Dear Healthcare Provider Letter","" "62","Truvada","140","07/16/2012","316","Full Prescribing Information","" "62","Truvada","140","07/16/2012","317","Important Safety Information about TRUVADA for a PrEP Indication for Healthcare Providers","" "62","Truvada","140","07/16/2012","318","Important Safety Information about TRUVADA for a PrEP Indication for Uninfected Individuals","" "62","Truvada","140","07/16/2012","319","Medication Guide","" "62","Truvada","140","07/16/2012","320","Prescriber Educational Slide Deck","" "62","Truvada","140","07/16/2012","321","Safety Information Fact Sheet","" "62","Truvada","140","07/16/2012","322","Training Guide for Healthcare Providers","" "63","Tysabri","143","01/20/2012","323","Medication Guide","" "63","Tysabri","143","01/20/2012","324","Educational Slide Set","" "63","Tysabri","143","01/20/2012","325","Program Overview","" "63","Tysabri","143","01/20/2012","326","Prescriber/Patient Enrollment Form - Crohn's Disease","" "63","Tysabri","143","01/20/2012","327","Prescriber/Patient Enrollment Form - MS","" "63","Tysabri","143","01/20/2012","328","Pre-Infusion Patient Checklist","" "63","Tysabri","143","01/20/2012","329","Guidance for Evaluation of New Neurologic Symptoms","" "63","Tysabri","143","01/20/2012","330","Understanding PML for Gastroenterologists","" "63","Tysabri","143","01/20/2012","331","TOUCH On-Line","" "63","Tysabri","143","01/20/2012","332","Change Prescriber Authorization Form","" "63","Tysabri","143","01/20/2012","333","12 Week Questionnaire for Crohn's Disease","" "63","Tysabri","143","01/20/2012","334","Patient Status Report and Reauthorization Questionnaire - Crohn's Disease","" "63","Tysabri","143","01/20/2012","335","Patient Status Report and Reauthorization Questionnaire - MS","" "63","Tysabri","143","01/20/2012","336","Initial Discontinuation Questionnaire - Crohn's Disease","" "63","Tysabri","143","01/20/2012","337","Patient 6-month Discontinuation Questionnaire - Crohn's Disease","" "63","Tysabri","143","01/20/2012","338","Infusion Site Enrollment Form","" "63","Tysabri","143","01/20/2012","339","Inventory Tracking Log","" "63","Tysabri","143","01/20/2012","340","Patient Discontinuation Questionnaire - MS","" "63","Tysabri","143","01/20/2012","341","Certified Pharmacy Enrollment Form","" "64","Versacloz","144","02/06/2013","342","Healthcare Provider Enrollment Form","" "64","Versacloz","144","02/06/2013","343","Pharmacy Enrollment Form","" "64","Versacloz","144","02/06/2013","344","Patient Enrollment Form","" "64","Versacloz","144","02/06/2013","345","Single Patient WBC Count and ANC Monitoring Form","" "64","Versacloz","144","02/06/2013","346","Multiple Patient WBC Count and ANC Monitoring Form","" "64","Versacloz","144","02/06/2013","347","REMS Website","" "62","Truvada","140","07/16/2012","363","REMS Website","" "46","Revlimid","111","02/08/2013","364","Pharmacy Certification Quiz","" "46","Revlimid","111","02/08/2013","365","CelgeneRiskManagement.com website","" "46","Revlimid","111","02/08/2013","366","Education and Prescribing Safety Kit","" "46","Revlimid","111","02/08/2013","367","Patient Prescription Form","" "46","Revlimid","111","02/08/2013","368","Patient Prescription Form (Veterans Administration)","" "46","Revlimid","111","02/08/2013","369","Patient Survey Reminder Card","" "46","Revlimid","111","02/08/2013","370","Pharmacy_Guide","" "46","Revlimid","111","02/08/2013","371","Pharmacy_Training","" "46","Revlimid","111","02/08/2013","372","Emergency Contraception Brochure","" "59","Tikosyn","136","07/11/2011","373","Dear Pharmacist Letter for new enrollees - Institutions","" "59","Tikosyn","136","07/11/2011","374","Dear Pharmacist Letter for re-certification - Institutions","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","375","TIRF REMS Access Program Overview (Inpatient)","" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","376","TIRF REMS Access Program Overview (Chain)","" "24","Isotretinoin iPLEDGE","172","10/22/2010","377","Birth Control Workbook","" "24","Isotretinoin iPLEDGE","172","10/22/2010","378","Contraception Referral Form and Contraception Counseling Guide","" "1","Actemra","179","10/21/2013","379","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_DEAR HEALTHCARE PROVIDER LETTER.pdf" "1","Actemra","179","10/21/2013","380","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_PRESCRIBER EDUCATION SLIDE DECK.pdf" "1","Actemra","179","10/21/2013","381","www.ACTEMRAREMS.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_ACTEMRA REMS WEBSITE SCREENSHOT.pdf" "1","Actemra","179","10/21/2013","382","REMS journal information piece for emergency medicine physicians","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR EMERGENCY MEDICINE PHYSICIANS AND EMERGENCY MEDICAL SERVICES PROFESSIONALS.pdf" "1","Actemra","179","10/21/2013","383","REMS journal information piece for gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR GASTROENTEROLOGISTS AND HEPATOLOGISTS.pdf" "1","Actemra","179","10/21/2013","384","REMS journal information piece for infectious disease specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR INFECTIOUS DISEASE SPECIALISTS.pdf" "1","Actemra","179","10/21/2013","385","REMS journal information piece for internists and internal medicine","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR INTERNISTS AND INTERNAL MEDICINE SUBSPECIALISTS.pdf" "1","Actemra","179","10/21/2013","386","REMS journal information piece for neurologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR NEUROLOGISTS.pdf" "1","Actemra","179","10/21/2013","387","REMS journal information piece for oncologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR ONCOLOGISTS.pdf" "1","Actemra","179","10/21/2013","388","REMS journal information piece for rheumatologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_JOURNAL INFORMATION PIECE FOR RHEUMATOLOGISTS.pdf" "2","Adasuve","324","12/09/2013","389","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "2","Adasuve","324","12/09/2013","390","Healthcare Facility Enrollment Information and Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_HEALTHCARE FACILITY ENROLLMENT INFORMATION AND FORM.pdf" "2","Adasuve","324","12/09/2013","391","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_REMS PROGRAM HEALTHCARE PROVIDER BROCHURE.pdf" "2","Adasuve","324","12/09/2013","392","Steps for Safe Use of ADASUVE","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_STEPS FOR SAFE USE.pdf" "2","Adasuve","324","12/09/2013","393","Order Set / Protocol Template","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_ORDER SET PROTOCOL TEMPLATE.pdf" "2","Adasuve","324","12/09/2013","394","ADASUVE Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_EDUCATION PROGRAM FOR HEALTHCARE PROFESSIONALS.pdf" "2","Adasuve","324","12/09/2013","395","ADASUVE REMS Website Screenshot (www.adasuverems.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_REMS WEBSITE.pdf" "2","Adasuve","324","12/09/2013","396","Wholesaler/Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_WHOLESALER DISTRIBUTOR ENROLLMENT FORM.pdf" "149","Adempas","740","06/11/2014","397","REMS Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS PRESCRIBER ENROLLMENT AND AGREEMENT FORM.pdf" "149","Adempas","740","06/11/2014","398","Prescriber Guide for the Adempas REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_PRESCRIBER GUIDE FOR THE ADEMPAS REMS PROGRAM .pdf" "149","Adempas","740","06/11/2014","399","REMS Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS GUIDE FOR FEMALES WHO CAN GET PREGNANT.pdf" "149","Adempas","740","06/11/2014","400","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_PATIENT ENROLLMENT AND CONSENT FORM .pdf" "149","Adempas","740","06/11/2014","401","REMS Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS REPRODUCTIVE POTENTIAL STATUS FORM .pdf" "149","Adempas","740","06/11/2014","402","REMS Program Website Screenshot (www.adempasREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS PROGRAM WEBSITE .pdf" "149","Adempas","740","06/11/2014","403","REMS Program Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS PROGRAM INPATIENT PHARMACY ENROLLMENT FORM .pdf" "319","Afrezza","752","06/27/2014","404","REMS Letter for Healthcare Providers (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS LETTER FOR HEALTHCARE PROVIDERS (PRINT VERSION).pdf" "319","Afrezza","752","06/27/2014","405","REMS Letter for Healthcare Providers (Email Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS LETTER FOR HEALTHCARE PROVIDERS (EMAIL VERSION).pdf" "319","Afrezza","752","06/27/2014","406","REMS Letter for Professional Societies (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS LETTER FOR PROFESSIONAL SOCIETIES (PRINT VERSION).pdf" "319","Afrezza","752","06/27/2014","407","REMS Letter for Professional Societies (Email Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS LETTER FOR PROFESSIONAL SOCIETIES (EMAIL VERSION).pdf" "319","Afrezza","752","06/27/2014","408","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS FACTSHEET.pdf" "319","Afrezza","752","06/27/2014","409","REMS Website Screenshot (www.AfrezzaREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2014-06-27_REMS WEBSITE.pdf" "6","Aranesp","325","12/31/2013","410","Dear Healthcare Provider (DHCP) Letter to Newly Identified HCPs who may Prescribe, or Prescribe and Dispense, ESAs for Patients with Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_DEAR HEALTHCARE PROVIDER (DHCP) LETTER TO HEALTHCARE PROVIDERS (HCPs) WHO PRESCRIBE ESAs (ERYTHROPOIESIS STIMULATING AGENTS) FOR PATIENTS WITH CANCER.pdf" "6","Aranesp","325","12/31/2013","411","ESA APPRISE Oncology Program Enrollment Form for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM ENROLLMENT FORM FOR HEALTHCARE PROVIDERS.pdf" "6","Aranesp","325","12/31/2013","412","ESA APPRISE Oncology Program Training Module for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM TRAINING MODULE FOR HEALTHCARE PROVIDERS.pdf" "6","Aranesp","325","12/31/2013","413","Steps for Healthcare Providers Who Prescribe, or Prescribe and Dispense, ESAs for Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_STEPS FOR HEALTHCARE PROVIDERS WHO PRESCRIBE, OR PRESCRIBE AND DISPENSE, ESAS FOR PATIENTS WITH CANCER.pdf" "6","Aranesp","325","12/31/2013","414","ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM PATIENT AND HEALTHCARE PROVIDER ACKNOWLEDGMENT FORM.pdf" "6","Aranesp","325","12/31/2013","415","ESA APPRISE Oncology Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM WEB SITE SCREENSHOTS.pdf" "6","Aranesp","325","12/31/2013","416","Dear Healthcare Provider (DHCP) Letter to Directors of Pharmacy/ Administrators of Newly Identified Hospitals That Dispense ESAs to Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_DEAR HEALTHCARE PROVIDER (DHCP) LETTER TO HOSPITALS THAT DISPENSE ESAs (ERYTHROPOIESIS STIMULATING AGENTS) FOR PATIENTS WITH CANCER.pdf" "6","Aranesp","325","12/31/2013","417","ESA APPRISE Oncology Program Enrollment Form for Hospitals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM ENROLLMENT FORM FOR HOSPITALS.pdf" "6","Aranesp","325","12/31/2013","418","ESA APPRISE Oncology Program Training Module for Hospital Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM TRAINING MODULE FOR HOSPITAL DESIGNEES.pdf" "6","Aranesp","325","12/31/2013","419","Steps for Hospitals and Hospital/Institution-affiliated Outpatient Facilities That Dispense ESAs to Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_STEPS FOR HOSPITALS AND HOSPITAL INSTITUTION AFFILIATED OUTPATIENT FACILITIES THAT DISPENSE ESAs TO PATIENTS WITH CANCER.pdf" "6","Aranesp","325","12/31/2013","420","Guidelines for Acknowledgment Form Integration Within Healthcare Systems and Clinics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_GUIDELINES FOR ACKNOWLEDGMENT FORM INTEGRATION WITHIN HEALTHCARE SYSTEMS AND CLINICS.pdf" "313","Aveed","723","03/05/2014","421","AVEED REMS Education Program for Healthcare Providers (with Knowledge Assessment)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS EDUCATION PROGRAM FOR HEALTHCARE PROVIDERS WITH KNOWLEDGE ASSESSMENT.pdf" "313","Aveed","723","03/05/2014","422","AVEED REMS Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_HEALTHCARE PROVIDER ENROLLMENT FORM.pdf" "313","Aveed","723","03/05/2014","423","AVEED REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS PROGRAM AN INTRODUCTION.pdf" "313","Aveed","723","03/05/2014","424","What You Need To Know About AVEED Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_WHAT YOU NEED TO KNOW ABOUT AVEED TREATMENT A PATIENT GUIDE.pdf" "313","Aveed","723","03/05/2014","425","AVEED REMS Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS WEBSITE.pdf" "313","Aveed","723","03/05/2014","426","AVEED REMS Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS EDUCATION PROGRAM FOR HEALTHCARE SETTINGS.pdf" "313","Aveed","723","03/05/2014","427","AVEED REMS Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_HEALTHCARE SETTING ENROLLMENT FORM.pdf" "10","Bydureon","39","01/27/2012","428","Dear Healthcare Professional letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bydureon_2012-01-27_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "10","Bydureon","39","01/27/2012","429","Highlighted Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bydureon_2012-01-27_HIGHLIGHTED INFORMATION FOR PRESCRIBERS .pdf" "10","Bydureon","39","01/27/2012","430","BYDUREON REMS Web Page Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bydureon_2012-01-27_REMS WEBPAGE.pdf" "11","Caprelsa","183","11/27/2013","431","Prescriber Training Program Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_PRESCRIBER TRAINING PROGRAM.pdf" "11","Caprelsa","183","11/27/2013","432","Prescriber Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_PRESCRIBER ENROLLMENT FORM.pdf" "11","Caprelsa","183","11/27/2013","433","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_MEDICATION GUIDE.pdf" "11","Caprelsa","183","11/27/2013","434","CAPRELSA Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_PHARMACY ENROLLMENT FORM.pdf" "11","Caprelsa","183","11/27/2013","435","CAPRELSA REMS Convention Panel","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_REMS_Convention_Panel.pdf" "11","Caprelsa","183","11/27/2013","436","CAPRELSA REMS Website Screenshot (www.caprelsarems.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_REMS_Website.pdf" "11","Caprelsa","183","11/27/2013","437","HCP Education Pamphlet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_HCP_Education_Pamphlet.pdf" "11","Caprelsa","183","11/27/2013","438","HCP Education slides set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_HCP_Education_Slide_Set.pdf" "14","Eliquis","46","12/28/2012","439","DHCP Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2012-12-28_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "14","Eliquis","46","12/28/2012","440","ELIQUIS REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2012-12-28_REMS WEBSITE.pdf" "14","Eliquis","46","12/28/2012","441","Professional Organization Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2012-12-28_DEAR PROFESSIONAL ORGANIZATION LETTER.pdf" "15","Entereg","184","10/18/2013","442","E.A.S.E. ENTEREG REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_E.A.S.E. ENTEREG REMS PROGRAM OVERVIEW.pdf" "15","Entereg","184","10/18/2013","443","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_DEAR HEALTHCARE PROVIDER LETTER.pdf" "15","Entereg","184","10/18/2013","444","Prescriber and Pharmacist Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_PRESCRIBER AND PHARMACIST INFORMATION BROCHURE.pdf" "15","Entereg","184","10/18/2013","445","Hospital Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_HOSPITAL PHARMACY ENROLLMENT FORM.pdf" "15","Entereg","184","10/18/2013","446","E.A.S.E. ENTEREG REMS Program Website Screenshot (www.ENTEREGREMS.COM)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_E.A.S.E. ENTEREG REMS PROGRAM WEBSITE.pdf" "16","Epogen / Procrit","326","12/31/2013","447","Dear Healthcare Provider (DHCP) Letter to Newly Identified HCPs who may Prescribe, or Prescribe and Dispense, ESAs for Patients with Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013- 12-31_DEAR HEALTHCARE PROVIDER (DHCP) LETTER TO HEALTHCARE PROVIDERS (HCPs) WHO PRESCRIBE ESAs (ERYTHROPOIESIS STIMULATING AGENTS) FOR PATIENTS WITH CANCER.pdf" "16","Epogen / Procrit","326","12/31/2013","448","ESA APPRISE Oncology Program Enrollment Form for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM ENROLLMENT FORM FOR HEALTHCARE PROVIDERS.pdf" "16","Epogen / Procrit","326","12/31/2013","449","ESA APPRISE Oncology Program Training Module for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM TRAINING MODULE FOR HEALTHCARE PROVIDERS.pdf" "16","Epogen / Procrit","326","12/31/2013","450","Steps for Healthcare Providers Who Prescribe, or Prescribe and Dispense, ESAs for Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_STEPS FOR HEALTHCARE PROVIDERS WHO PRESCRIBE, OR PRESCRIBE AND DISPENSE, ESAs FOR PATIENTS WITH CANCER.pdf" "16","Epogen / Procrit","326","12/31/2013","451","ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM PATIENT AND HEALTHCARE PROVIDER ACKNOWLEDGMENT FORM.pdf" "16","Epogen / Procrit","326","12/31/2013","452","ESA APPRISE Oncology Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM WEBSITE SCREENSHOTS.pdf" "16","Epogen / Procrit","326","12/31/2013","453","Dear Healthcare Provider (DHCP) Letter to Directors of Pharmacy/ Administrators of Newly Identified Hospitals That Dispense ESAs to Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_DEAR HEALTHCARE PROVIDER (DHCP) LETTER TO HOSPITALS THAT DISPENSE ESAs (ERYTHROPOIESIS STIMULATING AGENTS) FOR PATIENTS WITH CANCER.pdf" "16","Epogen / Procrit","326","12/31/2013","454","ESA APPRISE Oncology Program Enrollment Form for Hospitals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM ENROLLMENT FORM FOR HOSPITALS.pdf" "16","Epogen / Procrit","326","12/31/2013","455","ESA APPRISE Oncology Program Training Module for Hospital Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_ESA APPRISE ONCOLOGY PROGRAM TRAINING MODULE FOR HOSPITAL DESIGNEES.pdf" "16","Epogen / Procrit","326","12/31/2013","456","Steps for Hospitals and Hospital/Institution-affiliated Outpatient Facilities That Dispense ESAs to Patients With Cancer","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_STEPS FOR HOSPITALS AND HOSPITAL INSTITUTION AFFILIATED OUTPATIENT FACILITIES THAT DISPENSE ESAs TO PATIENTS WITH CANCER.pdf" "16","Epogen / Procrit","326","12/31/2013","457","Guidelines for Acknowledgment Form Integration Within Healthcare Systems and Clinics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_GUIDELINES FOR ACKNOWLEDGMENT FORM INTEGRATION WITHIN HEALTHCARE SYSTEMS AND CLINICS.pdf" "19","Forteo","711","08/30/2013","470","Dear HCP (DHCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Forteo_2013-08-30_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "19","Forteo","711","08/30/2013","471","A Direct Mail Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Forteo_2013-08-30_DIRECT MAIL LETTER.pdf" "19","Forteo","711","08/30/2013","472","Highlighted Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Forteo_2013-08-30_HIGHLIGHTED INFORMATION FOR PRESCRIBERS.pdf" "20","Fortesta","744","06/19/2014","473","Medication Guide","" "21","Gattex","754","06/26/2014","474","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "21","Gattex","754","06/26/2014","475","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_DEAR PROFESSIONAL SOCIETY LETTER.pdf" "21","Gattex","754","06/26/2014","476","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_PRESCRIBER EDUCATION SLIDE DECK.pdf" "21","Gattex","754","06/26/2014","477","What you need to know about gattex treatment: a patient and caregiver counseling guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_WHAT YOU NEED TO KNOW ABOUT GATTEX TREATMENT A PATIENT AND CAREGIVER COUNSELING GUIDE.pdf" "21","Gattex","754","06/26/2014","478","Gattex REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_REMS WEBSITE SCREENSHOTS.pdf" "22","Gilenya","186","05/28/2013","479","Dear Healthcare Professional Letter (DHCPL)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2013-05-28_DEAR HEALTHCARE PROFESSIONAL LETTER (DHCPL).pdf" "22","Gilenya","186","05/28/2013","480","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2013-05-28_DEAR PROFESSIONAL SOCIETY LETTER.pdf" "22","Gilenya","186","05/28/2013","481","Guide to Important Safety Information: Using GILENYA in Patients with Relapsing Forms of Multiple Sclerosis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2013-05-28_GUIDE TO IMPORTANT SAFETY INFORMATION USING GILENYA IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS.pdf" "22","Gilenya","186","05/28/2013","482","GILENYA REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2013-05-28_REMS WEBSITE.pdf" "186","Iclusig","327","12/20/2013","483","REMS Letter to Healthcare Providers(print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_DEAR HEALTHCARE PROVIDER LETTER (PRINT VERSION).pdf" "186","Iclusig","327","12/20/2013","484","REMS Letter to Healthcare Providers(email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_DEAR HEALTHCARE PROVIDER LETTER (EMAIL VERSION).pdf" "186","Iclusig","327","12/20/2013","485","REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_DEAR PROFESSIONAL SOCIETY LETTER (PRINT VERSION).pdf" "186","Iclusig","327","12/20/2013","486","REMS Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_DEAR PROFESSIONAL SOCIETY LETTER (EMAIL VERSION).pdf" "186","Iclusig","327","12/20/2013","487","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_REMS FACT SHEET.pdf" "186","Iclusig","327","12/20/2013","488","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_JOURNAL INFORMATION PIECE.pdf" "186","Iclusig","327","12/20/2013","489","Iclusig REMS Website (Landing Page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_REMS WEBSITE.pdf" "25","Juxtapid","187","08/13/2013","490","The Prescriber Training Module screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_PRESCRIBER TRAINING MODULE DOWNLOADABLE PDF AND ONLINE VERSIONS.pdf" "25","Juxtapid","187","08/13/2013","491","Prescriber Enrollment Form-downloadable PDF and online versions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_PRESCRIBER ENROLLMENT FORM DOWNLOADABLE PDF AND ONLINE VERSIONS.pdf" "25","Juxtapid","187","08/13/2013","492","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_DEAR HEALTHCARE PROVIDER (HCP) LETTER.pdf" "25","Juxtapid","187","08/13/2013","493","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_DEAR PROFESSIONAL SOCIETY LETTER.pdf" "25","Juxtapid","187","08/13/2013","494","JUXTAPID REMS Program Website Screenshot (www.JUXTAPIDREMSProgram.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_REMS WEB PAGES.pdf" "25","Juxtapid","187","08/13/2013","495","JUXTAPID REMS Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_PRESCRIPTION AUTHORIZATION FORM.pdf" "26","Krystexxa","188","10/10/2013","496","A Dear Healthcare Provider/ Dear Infusion Site Medical Personnel Letter (DHCP/DISMP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2013-10-10_DEAR HEALTHCARE PROVIDER OR INFUSION SITE MEDICAL PERSONNEL LETTER.pdf" "26","Krystexxa","188","10/10/2013","497","www.KRYSTEXXA.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2013-10-10_REMS WEBPAGES.pdf" "26","Krystexxa","188","10/10/2013","498","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2013-10-10_JOURNAL INFORMATION PIECE.pdf" "27","Kynamro","737","05/07/2014","499","Prescriber Training slide set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_PRESCRIBER TRAINING SLIDE SET.pdf" "27","Kynamro","737","05/07/2014","500","Summary of Monitoring Recommendations","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_SUMMARY OF MONITORING RECOMMENDATIONS.pdf" "27","Kynamro","737","05/07/2014","501","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_PRESCRIBER ENROLLMENT FORM.pdf" "27","Kynamro","737","05/07/2014","502","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_PRESCRIPTION AUTHORIZATION FORM.pdf" "27","Kynamro","737","05/07/2014","503","KYNAMRO REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_WEBSITE SCREEN SHOT LANDING PAGE.pdf" "28","Letairis","700","01/31/2014","504","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_MEDICATION GUIDE.pdf" "28","Letairis","700","01/31/2014","505","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_PRESCRIBER ENROLLMENT AND AGREEMENT FORM.pdf" "28","Letairis","700","01/31/2014","506","Prescriber Guide to the Letairis REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_PRESCRIBER GUIDE FOR THE LETAIRIS REMS PROGRAM.pdf" "28","Letairis","700","01/31/2014","507","Letairis REMS Program Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_REMS PROGRAM GUIDE FOR FEMALES WHO CAN GET PREGNANT.pdf" "28","Letairis","700","01/31/2014","508","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_PATIENT ENROLLMENT AND CONSENT FORM.pdf" "28","Letairis","700","01/31/2014","509","Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_REPRODUCTIVE POTENTIAL STATUS FORM.pdf" "28","Letairis","700","01/31/2014","510","Letairis REMS website (www.letairisrems.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_REMS WEBSITE.pdf" "29","Lotronex","738","05/08/2014","511","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL PRESCRIBER ENROLLMENT FORM.pdf" "29","Lotronex","738","05/08/2014","512","PPL Enrollment Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL ENROLLMENT LETTER.pdf" "29","Lotronex","738","05/08/2014","513","PPL Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL PRESCRIBER EDUCATION SLIDE DECK.pdf" "29","Lotronex","738","05/08/2014","515","LOTRONEXPPL Website For Prescriber Section Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL WEBSITE FOR PRESCRIBERS SECTION WEBSHOTS.pdf" "29","Lotronex","738","05/08/2014","516","PPL Kit Overview Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL KIT OVERVIEW LETTER.pdf" "29","Lotronex","738","05/08/2014","517","Patient Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PATIENT ACKNOWLEDGEMENT FORM.pdf" "29","Lotronex","738","05/08/2014","519","PPL stickers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL STICKERS.pdf" "29","Lotronex","738","05/08/2014","520","Patient Follow-Up Survey Pre-Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PATIENT FOLLOW-UP SURVEY FOR LOTRONEX TABLETS PRE ENROLLMENT FORM.pdf" "29","Lotronex","738","05/08/2014","521","PPL Sticker Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL STICKER SHEET.pdf" "29","Lotronex","738","05/08/2014","522","LOTRONEXPPL Website for Patients Section Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL WEBSITE FOR PATIENTS SECTION.pdf" "29","Lotronex","738","05/08/2014","523","Educational Mailing: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_EDUCATIONAL MAILING IMPORTANT INFORMATION FOR PHARMACISTS.pdf" "29","Lotronex","738","05/08/2014","524","PPL Pharmacist Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PRESCRIBING PROGRAM FOR LOTRONEX PHARMACIST EDUCATION SLIDE DECK.pdf" "29","Lotronex","738","05/08/2014","525","LOTRONEXPPL Website For Pharmacists Section Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL WEBSITE FOR PHARMACISTS SECTION WEBSHOTS.pdf" "29","Lotronex","738","05/08/2014","526","PPL Important Information for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_PPL IMPORTANT INFORMATION FOR PATIENTS.pdf" "36","Multaq","725","03/19/2014","538","Healthcare Professional Information Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_HEALTHCARE PROFESSIONAL INFORMATION SHEET.pdf" "36","Multaq","725","03/19/2014","539","Dear Healthcare Provider letter (permanent AF)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_DEAR HEALTHCARE PROFESSIONAL LETTER (DHCPL) PERMANENT AFIB.pdf" "36","Multaq","725","03/19/2014","540","Dear Healthcare Provider letter (hepatic)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_DEAR HEALTHCARE PROFESSIONAL LETTER (DHCPL) HEPATIC.pdf" "36","Multaq","725","03/19/2014","541","Updated Healthcare Provider Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_HEALTHCARE PROVIDER CHECKLIST.pdf" "36","Multaq","725","03/19/2014","542","Modified REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_REMS WEBSITE.pdf" "314","Myalept","755","06/30/2014","543","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_REMS PROGRAM PRESCRIBER TRAINING MODULE.pdf" "314","Myalept","755","06/30/2014","544","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_PRESCRIBER ENROLLMENT FORM.pdf" "314","Myalept","755","06/30/2014","545","MYALEPT REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_REMS PROGRAM AN INTRODUCTION.pdf" "314","Myalept","755","06/30/2014","546","Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_REMS PROGRAM WEBSITE.pdf" "314","Myalept","755","06/30/2014","547","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_PRESCRIPTION AUTHORIZATION FORM.pdf" "38","Nplate","93","12/06/2011","548","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _DEAR HEALTHCARE PROFESSIONAL LETTER .pdf" "38","Nplate","93","12/06/2011","549","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _DEAR PROFESSIONAL SOCIETY LETTER.pdf" "39","Nulojix","94","06/15/2011","550","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_REMS DOCUMENT .pdf" "39","Nulojix","94","06/15/2011","551","REMS Landing Page Screenshot (www.NULOJIX.com.REMS.aspx)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_REMS WEBSITE LANDING PAGE .pdf" "39","Nulojix","94","06/15/2011","552","Webinar Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_TRAINING FOR HEALTHCARE PROFESSIONALS EDUCATIONAL DECK .pdf" "39","Nulojix","94","06/15/2011","553","Dear HCP Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_DEAR HEALTHCARE PROFESSIONAL LETTER .pdf" "39","Nulojix","94","06/15/2011","554","HCP Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_HCP FACT SHEET .pdf" "39","Nulojix","94","06/15/2011","555","Dear Infusion Specialist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_DEAR INFUSION SPECIALIST LETTER .pdf" "39","Nulojix","94","06/15/2011","556","Pre-Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_PRE-INFUSION CHECKLIST .pdf" "40","Omontys","95","03/27/2012","558","Dear Healthcare Professional letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Omontys_2012-03-27_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "40","Omontys","95","03/27/2012","559","OMONTYS REMS Web Page Landing Page Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Omontys_2012-03-27_REMS SPECIFIC LINK ON OMONTYS WEBSITE LANDING SCREEN SHOT.pdf" "76","Opsumit","191","10/18/2013","561","Opsumit Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_PATIENT ENROLLMENT AND CONSENT FORM.pdf" "76","Opsumit","191","10/18/2013","562","Opsumit REMS Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_REMS GUIDE FOR FEMALES WHO CAN GET PREGNANT.pdf" "76","Opsumit","191","10/18/2013","563","Prescriber Guide for the Opsumit REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_PRESCRIBER GUIDE FOR THE OPSUMIT REMS PROGRAM.pdf" "76","Opsumit","191","10/18/2013","564","Opsumit REMS Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_REMS PRESCRIBER ENROLLMENT AND AGREEMENT FORM.pdf" "76","Opsumit","191","10/18/2013","565","Opsumit REMS Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_REMS REPRODUCTIVE POTENTIAL STATUS FORM.pdf" "76","Opsumit","191","10/18/2013","566","Opsumit REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_REMS WEBSITE.pdf" "76","Opsumit","191","10/18/2013","567","Opsumit REMS Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_INPATIENT PHARMACY ENROLLMENT FORM.pdf" "41","Pomalyst","192","11/15/2013","568","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PRESCRIBER ENROLLMENT FORM.pdf" "41","Pomalyst","192","11/15/2013","569","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PRESCRIPTION FORM.pdf" "41","Pomalyst","192","11/15/2013","570","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PRESCRIPTION FORM VETERANS ADMINISTRATION (VA) ONLY.pdf" "41","Pomalyst","192","11/15/2013","571","Prescriber Guide to POMALYST REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PRESCRIBER GUIDE TO POMALYST REMS PROGRAM.pdf" "41","Pomalyst","192","11/15/2013","572","POMALYST REMS™ At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_REMS AT A GLANCE.pdf" "41","Pomalyst","192","11/15/2013","573","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_DEAR PRESCRIBER WELCOME LETTER.pdf" "41","Pomalyst","192","11/15/2013","574","Celgene Risk Management.com website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_CELGENE RISK MANAGEMENT WEBSITE.pdf" "41","Pomalyst","192","11/15/2013","575","Pharmacy Guide to the POMALYST REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PHARMACY GUIDE TO REMS PROGRAM.pdf" "41","Pomalyst","192","11/15/2013","576","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_REMS EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES.pdf" "41","Pomalyst","192","11/15/2013","577","Celgene REMS Programs Pharmacy Training: the POMALYST REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_CELGENE REMS PROGRAMS PHARMACY TRAINING POMALYST REMS.pdf" "41","Pomalyst","192","11/15/2013","578","Pharmacy Certification Quiz (the POMALYST REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_REMS PHARMACY CERTIFICATION QUIZ.pdf" "41","Pomalyst","192","11/15/2013","579","Patient-Physician Agreement Form for Adult Males","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT MALE.pdf" "41","Pomalyst","192","11/15/2013","580","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR MALE CHILD.pdf" "41","Pomalyst","192","11/15/2013","581","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN NOT GET PREGNANT.pdf" "41","Pomalyst","192","11/15/2013","582","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN GET PREGNANT.pdf" "41","Pomalyst","192","11/15/2013","583","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN NOT GET PREGNANT.pdf" "41","Pomalyst","192","11/15/2013","584","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN GET PREGNANT.pdf" "41","Pomalyst","192","11/15/2013","585","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_REMS PATIENT SURVEY REMINDER.pdf" "41","Pomalyst","192","11/15/2013","586","POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program education and prescribing safety kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_REMS PROGRAM EDUCATION AND PRESCRIBING SAFETY KIT.pdf" "41","Pomalyst","192","11/15/2013","587","POMALYST REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2013-11-15_PATIENT RESOURCE PACK FOR REMS PROGRAM.pdf" "42","Potiga","98","03/19/2012","588","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Potiga_2012-03-19_Dear_Healthcare_Professional_Letter.pdf" "42","Potiga","98","03/19/2012","589","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Potiga_2012-03-19_Dear_Pharmacist_Letter.pdf" "45","Qsymia","108","04/16/2013","591","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_MEDICATION GUIDE.pdf" "45","Qsymia","108","04/16/2013","592","Risk of Birth Defects with Qsymia patient brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_RISK OF BIRTH DEFECTS WITH QSYMIA PATIENT BROCHURE.pdf" "45","Qsymia","108","04/16/2013","593","Healthcare Provider Counseling Tool for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_HEALTHCARE PROVIDER COUNSELING TOOL FOR FEMALES OF REPRODUCTIVE POTENTIAL.pdf" "45","Qsymia","108","04/16/2013","594","Prescriber Dosing and Management Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PRESCRIBER DOSING AND MANAGEMENT CHECKLIST.pdf" "45","Qsymia","108","04/16/2013","595","Online Qsymia REMS training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_ONLINE REMS HEALTHCARE PROVIDER TRAINING PROGRAM.pdf" "45","Qsymia","108","04/16/2013","596","Print Qsymia REMS training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PRINT REMS HEALTHCARE PROVIDER TRAINING PROGRAM.pdf" "45","Qsymia","108","04/16/2013","597","Dear Healthcare Provider","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_DEAR HEALTHCARE PROVIDER LETTER.pdf" "45","Qsymia","108","04/16/2013","598","Dear Medical Society letters","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_DEAR MEDICAL SOCIETY LETTER.pdf" "45","Qsymia","108","04/16/2013","599","Qsymia REMS website landing page screen shot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_REMS WESBITE.pdf" "45","Qsymia","108","04/16/2013","600","Pharmacy Enrollment Form, Independent Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PHARMACY ENROLLMENT FORM INDEPENDENT PHARMACY.pdf" "45","Qsymia","108","04/16/2013","601","Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PHARMACY ENROLLMENT FORM CORPORATE ENTITY OF RETAIL CHAIN PHARMACY.pdf" "45","Qsymia","108","04/16/2013","602","Pharmacy Enrollment Form, Mail Order Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PHARMACY ENROLLMENT FORM MAIL ORDER PHARMACY.pdf" "45","Qsymia","108","04/16/2013","603","Online Qsymia REMS Pharmacy Training module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_ONLINE REMS PHARMACY TRAINING PROGRAM.pdf" "45","Qsymia","108","04/16/2013","604","Print Qsymia REMS Pharmacy Training module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PRINT REMS PHARMACY TRAINING PROGRAM.pdf" "45","Qsymia","108","04/16/2013","605","Important Safety Information","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_IMPORTANT SAFETY INFORMATION.pdf" "45","Qsymia","108","04/16/2013","606","Highlights of Prescribing Information","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_HIGHLIGHTS OF PRESCRIBING INFORMATION.pdf" "45","Qsymia","108","04/16/2013","607","Voice Over (VO) DIRECTIONs FOR Healthcare Professional Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_ONLINE VOICE OVER (VO) DIRECTIONS FOR HEALTHCARE PROVIDER TRAINING PROGRAM.pdf" "45","Qsymia","108","04/16/2013","608","Print Qsymia REMS training (Kaiser HEALTHCARE PROVIDER USE ONLY)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2013-04-16_PRINT REMS HEALTHCARE PROVIDER TRAINING (KAISER HEALTHCARE PROVIDER USE ONLY) .pdf" "46","Revlimid","194","11/15/2013","609","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PRESCRIBER ENROLLMENT FORM.pdf" "46","Revlimid","194","11/15/2013","610","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PRESCRIPTION FORM.pdf" "46","Revlimid","194","11/15/2013","611","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PRESCRIPTION FORM VETERANS ADMINISTRATION (VA) ONLY.pdf" "46","Revlimid","194","11/15/2013","612","Prescriber Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PRESCRIBER GUIDE TO REMS PROGRAM.pdf" "46","Revlimid","194","11/15/2013","613","REVLIMID REMS™ At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_REMS AT A GLANCE.pdf" "46","Revlimid","194","11/15/2013","614","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_DEAR PRESCRIBER WELCOME LETTER.pdf" "46","Revlimid","194","11/15/2013","615","Celgene Risk Management.com website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_CELGENE RISK MANAGEMENT WEBSITE.pdf" "46","Revlimid","194","11/15/2013","616","Pharmacy Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PHARMACY GUIDE TO REMS PROGRAM.pdf" "46","Revlimid","194","11/15/2013","617","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_REMS EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES.pdf" "46","Revlimid","194","11/15/2013","618","Celgene REMS Programs Pharmacy Training: REVLIMID REMS™","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_CELGENE REMS PROGRAM PHARMACY TRAINING REVLIMID REMS.pdf" "46","Revlimid","194","11/15/2013","619","Pharmacy Certification Quiz (the REVLIMID REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_REMS PHARMACY CERTIFICATION QUIZ.pdf" "46","Revlimid","194","11/15/2013","620","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT MALE.pdf" "46","Revlimid","194","11/15/2013","621","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR MALE CHILD.pdf" "46","Revlimid","194","11/15/2013","622","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN NOT GET PREGNANT.pdf" "46","Revlimid","194","11/15/2013","623","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN GET PREGNANT.pdf" "46","Revlimid","194","11/15/2013","624","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN NOT GET PREGNANT.pdf" "46","Revlimid","194","11/15/2013","625","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN GET PREGNANT.pdf" "46","Revlimid","194","11/15/2013","626","Patient Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT GUIDE TO REMS PROGRAM.pdf" "46","Revlimid","194","11/15/2013","627","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_EMERGENCY CONTRACEPTION BROCHURE.pdf" "46","Revlimid","194","11/15/2013","628","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_REMS PATIENT SURVEY REMINDER CARD.pdf" "46","Revlimid","194","11/15/2013","629","REVLIMID Risk Evaluation andMitigation Strategy (REMS)™ Program Education and Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_REMS PROGRAM EDUCATION AND PRESCRIBING SAFETY KIT.pdf" "46","Revlimid","194","11/15/2013","630","REVLIMID REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_PATIENT RESOURCE PACK FOR REMS PROGRAM.pdf" "48","Sabril","195","10/26/2013","632","Dear Healthcare Professional (HCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "48","Sabril","195","10/26/2013","633","Dear HCP Medication Taper Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_DEAR HEALTHCARE PROFESSIONAL TAPER LETTER.pdf" "48","Sabril","195","10/26/2013","634","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_PRESCRIBER ENROLLMENT AND AGREEMENT FORM.pdf" "48","Sabril","195","10/26/2013","635","Treatment Initiation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_TREATMENT INITIATION FORM.pdf" "48","Sabril","195","10/26/2013","636","Treatment Maintenance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_TREATMENT MAINTENANCE FORM.pdf" "48","Sabril","195","10/26/2013","637","Ophthalmologic Assessment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_OPHTHALMOLOGIC ASSESSMENT FORM.pdf" "48","Sabril","195","10/26/2013","638","Patient/Parent/Legal Guardian-Physician Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_PATIENT PARENT LEGAL GUARDIAN PHYSICIAN AGREEMENT FOR SABRIL USE FORM.pdf" "49","Soliris","735","04/30/2014","639","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_DEAR SOLIRIS PRESCRIBER LETTER AND HEALTHCARE PROVIDER ENROLLMENT FORM.pdf" "49","Soliris","735","04/30/2014","640","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_IMPORTANT SAFETY INFORMATION FOR PATIENTS BROCHURE.pdf" "49","Soliris","735","04/30/2014","641","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_IMPORTANT SAFETY INFORMATION FOR THE HEALTHCARE PROVIDER.pdf" "49","Soliris","735","04/30/2014","642","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_DOSING AND ADMINISTRATION GUIDE.pdf" "49","Soliris","735","04/30/2014","643","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_REMS WEBSITE.pdf" "50","Stelara","196","09/20/2013","644","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "50","Stelara","196","09/20/2013","645","Dear Healthcare Professional Letter (Rheumatology)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_DEAR HEALTHCARE PROFESSIONAL LETTER (RHEUMATOLOGY).pdf" "50","Stelara","196","09/20/2013","646","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_DEAR PHARMACIST LETTER.pdf" "50","Stelara","196","09/20/2013","647","REMS Journal Information Piece for Dermatologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_JOURNAL INFORMATION PIECE FOR DERMATOLOGISTS.pdf" "50","Stelara","196","09/20/2013","648","REMS Journal Information Piece for Oncologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_JOURNAL INFORMATION PIECE FOR ONCOLOGISTS.pdf" "50","Stelara","196","09/20/2013","649","REMS Journal Information Piece for Rheumatologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_JOURNAL INFORMATION PIECE FOR RHEUMATOLOGISTS.pdf" "50","Stelara","196","09/20/2013","650","REMS Journal Information Piece for Infectious Disease Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_JOURNAL INFORMATION PIECE FOR INFECTIOUS DISEASE SPECIALISTS.pdf" "50","Stelara","196","09/20/2013","651","REMS Journal Information Piece for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_JOURNAL INFORMATION PIECE FOR GASTROENTEROLOGISTS.pdf" "52","Suboxone sublingual film","731","04/28/2014","653","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_DEAR PRESCRIBER LETTER.pdf" "52","Suboxone sublingual film","731","04/28/2014","654","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_DEAR PHARMACIST LETTER.pdf" "52","Suboxone sublingual film","731","04/28/2014","655","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_APPROPRIATE USE CHECKLIST.pdf" "52","Suboxone sublingual film","731","04/28/2014","656","Prescriber Brochure, “Office‐Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PRESCRIBERS.pdf" "52","Suboxone sublingual film","731","04/28/2014","657","Pharmacist Brochure, “Office‐Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PHARMACISTS.pdf" "52","Suboxone sublingual film","731","04/28/2014","658","SUBOXONE Sublingual Film REMS Website Screenshot (www.SuboxoneFilmREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_REMS WEBSITE.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","661","REMS Instruction Letter to Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_IMPORTANT SAFETY INFORMATION FOR PRESCRIBERS LETTER .pdf" "315","Suboxone sublingual tablets","733","12/22/2011","662","REMS Introductory Letter to Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_IMPORTANT SAFETY INFORMATION FOR PHARMACISTS LETTER.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","663","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_APPROPRIATE USE CHECKLIST.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","664","Physician Brochure, “Important Information for Physicians- Frequently Asked Questions”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_INITIATING OFFICE BASED OPIOID THERAPY IMPORTANT INFORMATION FOR PHYSICIANS FREQUENTLY ASKED QUESTIONS.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","665","Pharmacist Brochure, “Important Information for Pharmacists- Frequently Asked Questions"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_INITIATING OFFICE BASED OPIOID THERAPY IMPORTANT INFORMATION FOR PHARMACISTS FREQUENTLY ASKED QUESTIONS.pdf" "53","Subutex","124","12/22/2011","668","REMS Instruction Letter to Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_IMPORTANT SAFETY INFORMATION FOR PRESCRIBERS LETTER.pdf" "53","Subutex","124","12/22/2011","669","REMS Introductory Letter to Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_IMPORTANT SAFETY INFORMATION FOR PHARMACISTS LETTER.pdf" "53","Subutex","124","12/22/2011","670","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_APPROPRIATE USE CHECKLIST.pdf" "53","Subutex","124","12/22/2011","671","Physician Brochure, “Important Information for Physicians- Frequently Asked Questions”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_INITIATING OFFICE BASED OPIOID THERAPY IMPORTANT INFORMATION FOR PHYSICIANS FREQUENTLY ASKED QUESTIONS.pdf" "53","Subutex","124","12/22/2011","672","Pharmacist Brochure, “Important Information for Pharmacists- Frequently Asked Questions”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_INITIATING OFFICE BASED OPIOID THERAPY IMPORTANT INFORMATION FOR PHARMACISTS FREQUENTLY ASKED QUESTIONS.pdf" "320","Symlin","753","06/27/2014","674","REMS Letter for Health Care Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_DEAR HEALTHCARE PROVIDER LETTER (PRINT VERSION).pdf" "320","Symlin","753","06/27/2014","675","REMS Letter for Health Care Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_DEAR HEALTHCARE PROVIDER LETTER (EMAIL VERSION).pdf" "320","Symlin","753","06/27/2014","676","REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_DEAR PROFESSIONAL ORGANIZATION LETTER (PRINT VERSION).pdf" "320","Symlin","753","06/27/2014","677","REMS Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_DEAR PROFESSIONAL ORGANIZATION LETTER (EMAIL VERSION).pdf" "320","Symlin","753","06/27/2014","678","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_FDA REQUIRED SYMLIN REMS SAFETY INFORMATION FACTSHEET.pdf" "320","Symlin","753","06/27/2014","679","SYMLIN REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_REMS WEBSITE.pdf" "316","Tanzeum","734","04/15/2014","680","The REMS Letter for Healthcare Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_DEAR HEALTHCARE PROVIDER LETTER (PRINT VERSION).pdf" "316","Tanzeum","734","04/15/2014","681","The REMS Letter for Healthcare Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_DEAR HEALTHCARE PROVIDER LETTER (EMAIL VERSION).pdf" "316","Tanzeum","734","04/15/2014","682","The REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_DEAR PROFESSIONAL SOCIETY LETTER (PRINT VERSION).pdf" "316","Tanzeum","734","04/15/2014","683","The REMS Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_DEAR PROFESSIONAL SOCIETY LETTER (EMAIL VERSION).pdf" "316","Tanzeum","734","04/15/2014","684","The REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_FDA REQUIRED REMS SAFETY INFORMATION FACTSHEET.pdf" "316","Tanzeum","734","04/15/2014","685","The TANZEUM REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_REMS WEBSITE .pdf" "317","testosterone (NDA 203098)","750","06/19/2014","686","Medication Guide","" "58","Thalomid","197","11/15/2013","687","Pharmacy Guide to the THALOMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PHARMACY GUIDE TO REMS PROGRAM.pdf" "58","Thalomid","197","11/15/2013","688","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES.pdf" "58","Thalomid","197","11/15/2013","689","Celgene REMS Programs Pharmacy Training: the THALOMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_CELGENE REMS PROGRAMS PHARMACY TRAINING THALOMID REMS.pdf" "58","Thalomid","197","11/15/2013","690","Pharmacy Certification Quiz (the THALOMID REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_REMS PHARMACY CERTIFICATION QUIZ.pdf" "58","Thalomid","197","11/15/2013","691","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT MALE.pdf" "58","Thalomid","197","11/15/2013","692","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR MALE CHILD.pdf" "58","Thalomid","197","11/15/2013","693","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN NOT GET PREGNANT.pdf" "58","Thalomid","197","11/15/2013","694","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR ADULT FEMALE WHO CAN GET PREGNANT.pdf" "58","Thalomid","197","11/15/2013","695","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN NOT GET PREGNANT.pdf" "58","Thalomid","197","11/15/2013","696","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PHYSICIAN AGREEMENT FORM FOR FEMALE CHILD WHO CAN GET PREGNANT.pdf" "58","Thalomid","197","11/15/2013","697","Patient Guide to THALOMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT GUIDE TO REMS PROGRAM.pdf" "58","Thalomid","197","11/15/2013","698","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_EMERGENCY CONTRACEPTION BROCHURE.pdf" "58","Thalomid","197","11/15/2013","699","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_REMS PATIENT SURVEY REMINDER.pdf" "58","Thalomid","197","11/15/2013","700","THALOMID Risk Evaluation and Mitigation Strategy (REMS)™ Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_REMS PROGRAM EDUCATION AND PRESCRIBING SAFETY KIT.pdf" "58","Thalomid","197","11/15/2013","701","THALOMID REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT RESOURCE PACK.pdf" "58","Thalomid","197","11/15/2013","702","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PRESCRIBER ENROLLMENT FORM.pdf" "58","Thalomid","197","11/15/2013","703","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PRESCRIPTION FORM.pdf" "58","Thalomid","197","11/15/2013","704","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PATIENT PRESCRIPTION FORM VETERANS ADMINISTRATION (VA) ONLY.pdf" "58","Thalomid","197","11/15/2013","705","Prescriber Guide to THALOMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_PRESCRIBER GUIDE TO REMS PROGRAM.pdf" "58","Thalomid","197","11/15/2013","706","THALOMID REMS™ At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_REMS AT A GLANCE.pdf" "58","Thalomid","197","11/15/2013","707","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_DEAR PRESCRIBER WELCOME LETTER.pdf" "58","Thalomid","197","11/15/2013","708","Celgene Risk Management.com website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2013-11-15_CELGENE RISK MANAGEMENT WEBSITE.pdf" "59","Tikosyn","198","12/06/2013","709","Dear Healthcare Provider Letter for re-certification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PRESCRIBER LETTER FOR PRESCRIBER RE-CERTIFICATION.pdf" "59","Tikosyn","198","12/06/2013","710","Dear Healthcare Provider Letter for new enrollees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PRESCRIBER LETTER FOR NEW PRESCRIBER CERTIFICATION.pdf" "59","Tikosyn","198","12/06/2013","711","Tikosyn Program Treatment Guidelines","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_TREATMENT GUIDELINES.pdf" "59","Tikosyn","198","12/06/2013","712","Prescriber Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_PRESCRIBER CERTIFICATION FORM.pdf" "59","Tikosyn","198","12/06/2013","713","Tikosyn REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_REMS WEBSITE.pdf" "59","Tikosyn","198","12/06/2013","714","Dear Pharmacist Letter for re-certification (Institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PHARMACIST LETTER FOR INSTITUTION RE CERTIFICATION.pdf" "59","Tikosyn","198","12/06/2013","715","Dear Pharmacist Letter for re-certification (Retail/Mail-order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PHARMACIST LETTER FOR RETAIL OR MAIL ORDER PHARMACY RE CERTIFICATION.pdf" "59","Tikosyn","198","12/06/2013","716","Dear Pharmacist Letter for new enrollees (Institution Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PHARMACIST LETTER FOR NEW INSTITUTION PHARMACY CERTIFICATION .pdf" "59","Tikosyn","198","12/06/2013","717","Dear Pharmacist Letter for new enrollees (Retail/Mail-order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_DEAR PHARMACIST LETTER FOR NEW RETAIL OR MAIL ORDER PHARMACY CERTIFICATION .pdf" "59","Tikosyn","198","12/06/2013","718","Pharmacy Certification Form (Institution Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_INSTITUTION PHARMACY CERTIFICATION FORM.pdf" "59","Tikosyn","198","12/06/2013","719","Pharmacy Certification Form (Retail/Mail-order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_RETAIL OR MAIL ORDER PHARMACY CERTIFICATION FORM.pdf" "59","Tikosyn","198","12/06/2013","720","T.I.P.S. Program Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_TIPS PROCEDURES BOOKLET.pdf" "61","Tracleer","199","07/01/2013","723","Tracleer Enrollment for Patients and Prescribers forms","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_ENROLLMENT FOR PATIENTS AND PRESCRIBERS FORM.pdf" "61","Tracleer","199","07/01/2013","724","Prescriber Essentials guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_PRESCRIBER ESSENTIALS GUIDE.pdf" "61","Tracleer","199","07/01/2013","725","Prescriber Certification form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_PRESCRIBER CERTIFICATION FORM .pdf" "61","Tracleer","199","07/01/2013","726","Tracleer Renewal form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_RENEWAL FORM.pdf" "61","Tracleer","199","07/01/2013","727","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_DEAR PRESCRIBER LETTER.pdf" "61","Tracleer","199","07/01/2013","728","Tracleer REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_REMS WEBSITE.pdf" "61","Tracleer","199","07/01/2013","729","FRM 549-COP-US, Request for > 30-Day Supply","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_FRM 549 COP US 30 PLUS DAY REQUEST AND JUSTIFICATION FORM.pdf" "61","Tracleer","199","07/01/2013","730","Prescriber letter from certified pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_DEAR PRESCRIBER LETTER FROM CERTIFIED PHARMACY.pdf" "61","Tracleer","199","07/01/2013","731","Patient Information Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_PATIENT INFORMATION SHEET.pdf" "61","Tracleer","199","07/01/2013","732","Tracleer Access Program Hospital Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_ACCESS PROGRAM HOSPITAL CERTIFICATION FORM.pdf" "61","Tracleer","199","07/01/2013","733","Dear Hospital Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_DEAR HOSPITAL LETTER.pdf" "61","Tracleer","199","07/01/2013","734","Patient Essentials Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_PATIENT ESSENTIALS GUIDE .pdf" "61","Tracleer","199","07/01/2013","735","Monthly Reminder Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_IMPORTANT REMINDERS FOR PATIENTS WALLET CARD.pdf" "62","Truvada","748","06/18/2014","737","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_DEAR HEALTHCARE PROVIDER LETTER.pdf" "62","Truvada","748","06/18/2014","738","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_TRAINING GUIDE FOR HEALTHCARE PROVIDERS.pdf" "62","Truvada","748","06/18/2014","739","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_HEALTHCARE PROVIDER TRAINING.pdf" "62","Truvada","748","06/18/2014","740","Important Safety Information about TRUVADA for a PrEP Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_IMPORTANT SAFETY INFORMATION ABOUT TRUVADA FOR A PRE EXPOSURE PROPHYLAXIS INDICATION FOR HEALTHCARE PROVIDERS.pdf" "62","Truvada","748","06/18/2014","741","Important Safety Information about TRUVADA to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_IMPORTANT SAFETY INFORMATION ABOUT TRUVADA TO REDUCE THE RISK OF GETTING HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV 1) INFECTION .pdf" "62","Truvada","748","06/18/2014","742","Agreement Form for Initiating TRUVADA for Pre-Exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_AGREEMENT FORM.pdf" "62","Truvada","748","06/18/2014","743","Checklist for Prescribers: Initiation of TRUVADA for Pre-exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_CHECKLIST FOR PRESCRIBERS.pdf" "62","Truvada","748","06/18/2014","744","Safety Information Fact Sheet for Prescribers about TRUVADA for a Pre-exposure Prophylaxis (PrEP) Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_SAFETY INFORMATION FACT SHEET FOR PRESCRIBERS .pdf" "62","Truvada","748","06/18/2014","745","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18-Journal_Information_Piece.pdf" "63","Tysabri","330","12/15/2013","748","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_PRESCRIBER PATIENT ENROLLMENT FORM MULTIPLE SCLEROSIS.pdf" "63","Tysabri","330","12/15/2013","749","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_PRESCRIBER PATIENT ENROLLMENT FORM CROHNS DISEASE.pdf" "63","Tysabri","330","12/15/2013","750","Pre-Infusion Patient Checklist (combined MS and CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_PRE INFUSION PATIENT CHECKLIST.pdf" "63","Tysabri","330","12/15/2013","751","Guidance for Evaluation of New Neurologic Symptoms in Patients Receiving TYSABRI (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_GUIDANCE FOR EVALUATION OF NEW NEUROLOGICAL SYMPTOMS IN PATIENTS RECEIVING TYSABRI.pdf" "63","Tysabri","330","12/15/2013","752","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_UNDERSTANDING PML FOR GASTROENTEROLOGISTS.pdf" "63","Tysabri","330","12/15/2013","753","TOUCH On-Line Website Screenshot (www.TOUCHPROGRAM.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_TOUCH ONLINE WEBSITE.pdf" "63","Tysabri","330","12/15/2013","754","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_CHANGE PRESCRIBER AUTHORIZATION FORM.pdf" "63","Tysabri","330","12/15/2013","755","12 Week Questionnaire for Crohn’s Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_12 WEEK QUESTIONNAIRE FOR CROHNS DISEASE.pdf" "63","Tysabri","330","12/15/2013","756","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_PATIENT STATUS REPORT AND REAUTHORIZATION QUESTIONNAIRE MULTIPLE SCLEROSIS.pdf" "63","Tysabri","330","12/15/2013","757","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_PATIENT STATUS REPORT AND REAUTHORIZATION QUESTIONNAIRE CROHNS DISEASE.pdf" "63","Tysabri","330","12/15/2013","758","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_INITIAL DISCONTINUATION QUESTIONNAIRE MULTIPLE SCLEROSIS.pdf" "63","Tysabri","330","12/15/2013","759","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_INITIAL DISCONTINUATION QUESTIONNAIRE CROHNS DISEASE.pdf" "63","Tysabri","330","12/15/2013","760","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_6 MONTH DISCONTINUATION QUESTIONNAIRE MULTIPLE SCLEROSIS.pdf" "63","Tysabri","330","12/15/2013","761","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_6 MONTH DISCONTINUATION QUESTIONNAIRE CROHNS DISEASE.pdf" "63","Tysabri","330","12/15/2013","762","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_TOUCH PRESCRIBING PROGRAM EDUCATIONAL SLIDE SET.pdf" "63","Tysabri","330","12/15/2013","763","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_TOUCH PRESCRIBING PROGRAM OVERVIEW.pdf" "63","Tysabri","330","12/15/2013","764","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_CERTIFIED PHARMACY ENROLLMENT FORM.pdf" "63","Tysabri","330","12/15/2013","765","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_INFUSION SITE ENROLLMENT FORM.pdf" "64","Versacloz","201","12/05/2013","766","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_HEALTHCARE PROVIDER ENROLLMENT FORM.pdf" "64","Versacloz","201","12/05/2013","767","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_PHARMACY PHARMACIST ENROLLMENT FORM.pdf" "64","Versacloz","201","12/05/2013","768","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_PATIENT ENROLLMENT FORM.pdf" "64","Versacloz","201","12/05/2013","769","Single Patient WBC Count and ANC Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_SINGLE PATIENT WBC COUNT AND ANC MONITORING FORM.pdf" "64","Versacloz","201","12/05/2013","770","Multiple Patient WBC Count and ANC Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_MULTI PATIENT WBC COUNT AND ANC MONITORING FORM.pdf" "64","Versacloz","201","12/05/2013","771","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_REMS WEBSITE.pdf" "65","Vibativ","147","06/21/2013","772","Medication Guide","" "65","Vibativ","147","06/21/2013","773","Dear Healthcare Provider (DHCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vibativ_2013-06-21_Dear Healthcare Provider Letter.pdf" "66","Victoza","149","05/18/2011","774","Reminder Dear Healthcare Professional Letter for Primary Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2011-05-18_DEAR HEALTHCARE PROFESSIONAL LETTER FOR PRIMARY CARE PROVIDERS.pdf" "66","Victoza","149","05/18/2011","775","Direct Mail Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2011-05-18_DIRECT MAIL LETTER.pdf" "66","Victoza","149","05/18/2011","776","VICTOZA® REMS landing page screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2011-05-18_REMS WEBSITE LANDING PAGE SCREENSHOT.pdf" "67","Vivitrol","202","07/29/2013","777","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2013-07-29_Full.pdf" "67","Vivitrol","202","07/29/2013","778","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2013-07-29_REMS DOCUMENT.pdf" "67","Vivitrol","202","07/29/2013","779","Dear Healthcare Provider (DHCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2013-07-29_DEAR HEALTHCARE PROVIDER LETTER.pdf" "67","Vivitrol","202","07/29/2013","780","VIVITROL Patient Counseling Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2013-07-29_PATIENT COUNSELING TOOL .pdf" "67","Vivitrol","202","07/29/2013","781","Key Techniques to Reduce Severe Injection Site Reactions poster","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2013-07-29_KEY TECHNIQUES TO REDUCE SEVERE INJECTION SITE REACTIONS.pdf" "69","Xeljanz","727","03/26/2014","782","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_MEDICATION GUIDE.pdf" "69","Xeljanz","727","03/26/2014","783","Dear Healthcare Provider letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_DEAR HEALTHCARE PROVIDER LETTER.pdf" "69","Xeljanz","727","03/26/2014","784","Dear Pharmacist letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_DEAR PHARMACIST LETTER.pdf" "69","Xeljanz","727","03/26/2014","785","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_JOURNAL INFORMATION PIECE FOR EMERGENCY MEDICINE SPECIALISTS.pdf" "69","Xeljanz","727","03/26/2014","786","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_JOURNAL INFORMATION PIECE FOR FAMILY PRACTITIONERS, GENERAL PRACTITIONERS, AND INTERNAL MEDICINE SPECIALISTS.pdf" "69","Xeljanz","727","03/26/2014","787","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_JOURNAL INFORMATION PIECE FOR INFECTIOUS DISEASE SPECIALISTS.pdf" "69","Xeljanz","727","03/26/2014","788","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_JOURNAL INFORMATION PIECE FOR PHARMACISTS.pdf" "69","Xeljanz","727","03/26/2014","789","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_JOURNAL INFORMATION PIECE FOR RHEUMATOLOGISTS OR RHEUMATOLOGY HEALTHCARE PROVIDERS (INCLUDING PHYSICIAN ASSISTANTS AND NURSE PRACTITIONERS).pdf" "69","Xeljanz","727","03/26/2014","790","Landing page for the XELJANZ REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2014-03-26_REMS WEBSITE SCREENSHOT.pdf" "70","Xenazine","205","08/02/2013","791","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_REMS DOCUMENT.pdf" "70","Xenazine","205","08/02/2013","792","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_DEAR HEALTHCARE PROFESSIONAL LETTER.pdf" "70","Xenazine","205","08/02/2013","793","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_DEAR PHARMACIST LETTER.pdf" "70","Xenazine","205","08/02/2013","794","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_Full.pdf" "70","Xenazine","205","08/02/2013","795","Prescribing Xenazine(tetrabenazine) Tablets: A Healthcare Professional Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_A HEALTHCARE PROFESSIONAL GUIDE.pdf" "70","Xenazine","205","08/02/2013","796","Patient/Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_PATIENT CAREGIVER COUNSELING GUIDE.pdf" "70","Xenazine","205","08/02/2013","797","Initial Dosing Plan","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_INITIAL DOSING PLAN.pdf" "70","Xenazine","205","08/02/2013","798","Xenazine Fact Sheet for Healthcare Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xenazine_2013-08-02_FACT SHEET FOR HEALTHCARE PROFESSIONALS.pdf" "71","Xiaflex","206","12/06/2013","799","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_DEAR HEALTHCARE PROVIDER LETTER.pdf" "71","Xiaflex","206","12/06/2013","800","Training Guide for the Administration of XIAFLEX for Dupuytren’s contracture","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_TRAINING GUIDE FOR THE ADMINISTRATION OF XIAFLEX FOR DUPUYTRENS CONTRACTURE.pdf" "71","Xiaflex","206","12/06/2013","801","XIAFLEX Procedure Training Video for Dupuytren’s Contracture","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_TRAINING VIDEO FOR TREATMENT OF DUPUYTRENS CONTRACTURE.pdf" "71","Xiaflex","206","12/06/2013","802","XIAFLEX REMS Program Website Screenshot (www.XIAFLEXREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_REMS WEBSITE.pdf" "71","Xiaflex","206","12/06/2013","803","REMS Training Guide for Administering XIAFLEX for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_TRAINING GUIDE FOR ADMINISTERING XIALFEX FOR PEYRONIES DISEASE.pdf" "71","Xiaflex","206","12/06/2013","804","REMS Training Video for Administering XIAFLEX for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_TRAINING VIDEO FOR ADMINISTERING XIAFLEX FOR PEYRONIES DISEASE.pdf" "71","Xiaflex","206","12/06/2013","805","Healthcare Provider Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_HEALTHCARE PROVIDER ENROLLMENT FORM FOR PEYRONIES DISEASE.pdf" "71","Xiaflex","206","12/06/2013","806","Patient Counseling Tool: What You Need to Know About XIAFLEX Treatment for Peyronie’s disease: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_WHAT YOU NEED TO KNOW ABOUT XIAFLEX TREATMENT FOR PEYRONIES DISEASE A PATIENT GUIDE.pdf" "71","Xiaflex","206","12/06/2013","807","XIAFLEX REMS Pharmacy/Healthcare Setting Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_PHARMACY OR HEALTHCARE SETTING ENROLLMENT FORM FOR PEYRONIES DISEASE.pdf" "72","Yervoy","162","02/16/2012","808","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_DEAR HEALTHCARE PROVIDER LETTER.pdf" "72","Yervoy","162","02/16/2012","809","Immune-Mediated Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_IMMUNE MEDIATED ADVERSE REACTION MANAGEMENT GUIDE.pdf" "72","Yervoy","162","02/16/2012","810","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_PATIENT WALLET CARD.pdf" "72","Yervoy","162","02/16/2012","811","Nursing Immune-Mediated Adverse Reaction Symptom Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_NURSING IMMUNE MEDIATED ADVERSE REACTION CHECKLIST.pdf" "72","Yervoy","162","02/16/2012","812","REMS-dedicated Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_REMS WEBSITE.pdf" "321","Zydelig","758","07/23/2014","813","REMS Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_DEAR HEALTHCARE PROVIDER LETTER.pdf" "321","Zydelig","758","07/23/2014","814","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_DEAR PROFESSIONAL SOCIETY LETTER.pdf" "321","Zydelig","758","07/23/2014","815","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_FACT SHEET.pdf" "321","Zydelig","758","07/23/2014","816","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_FDA REQUIRED SAFETY INFORMATION.pdf" "321","Zydelig","758","07/23/2014","817","Zydelig REMS Website (Landing Page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_REMS WEBSITE.pdf" "321","Zydelig","758","07/23/2014","818","Zydelig Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_PATIENT SAFETY INFORMATION CARD.pdf" "74","Zyprexa Relprevv","167","03/27/2013","819","Medication Guide","" "74","Zyprexa Relprevv","167","03/27/2013","820","Zyprexa Relprevv Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_PATIENT CARE PROGRAM INSTRUCTIONS BROCHURE.pdf" "74","Zyprexa Relprevv","167","03/27/2013","821","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_PRESCRIBER REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","822","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_PHARMACY REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","823","Buy & Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_BUY AND BILL PHARMACY SERVICE PROVIDER REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","824","Zyprexa Relprevv Healthcare Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_TRAINING FOR HEALTHCARE PROFESSIONALS.pdf" "74","Zyprexa Relprevv","167","03/27/2013","825","Zyprexa Relprevv Reconstitution and Administration Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_INSTRUCTIONS TO RECONSTITUTE AND ADMINISTER ZYPREXA RELPREVV.pdf" "74","Zyprexa Relprevv","167","03/27/2013","826","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_HEALTHCARE FACILITLY REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","827","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_PATIENT REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","828","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_SINGLE PATIENT INJECTION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","829","Multiple Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_MULTIPLE PATIENT INJECTION FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","830","Post-Injection Delirium/Sedation Syndrome Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_POST INJECTION DELIRIUM OR SEDATION SYNDROME (PDSS) FORM.pdf" "74","Zyprexa Relprevv","167","03/27/2013","831","PATIENT CARE PROGRAM Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_PATIENT CARE PROGRAM WEBSITE.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","832","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_DEAR PRESCRIBER LETTER.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","833","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_DEAR PHARMACIST LETTER.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","834","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_APPROPRIATE USE CHECKLIST.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","835","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PRESCRIBERS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","836","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PHARMACISTS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","837","BTOD REMS Website (www.btodrems.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_REMS WEBSITE.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","841","The Guide to Best Practices For the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_THE GUIDE TO BEST PRACTICES FOR THE IPLEDGE PROGRAM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","842","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PRESCRIBER CONTRACEPTION COUNSELING GUIDE.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","843","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_BE PREPARED BE PROTECTED VIDEO SCRIPT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","844","Recognizing Psychiatric Disorders In Adolescents And Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_RECOGNIZING PSYCHIATRIC DISORDERS IN ADOLESCENTS AND YOUNG ADULTS.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","845","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_REQUEST FOR EXEMPTION FOR PATIENTS WITH SERIOUS MEDICAL REASONS.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","846","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_OFFICE STAFF DESIGNEE REGISTRATION FORM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","847","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_REGISTERING AND MANAGING OFFICE STAFF DESIGNEES INSTRUCTIONS.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","848","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PRESCRIBER REGISTRATION FORM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","849","Pharmacist Guide for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_THE PHARMACIST GUIDE FOR THE IPLEDGE PROGRAM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","850","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PHARMACY REGISTRATION FORM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","851","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_GUIDE TO ISOTRETINOIN FOR FEMALE PATIENTS WHO CAN GET PREGNANT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","852","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_GUIDE TO ISOTRETINOIN FOR MALE PATIENTS AND FEMALE PATIENTS WHO CANNOT GET PREGNANT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","853","The iPLEDGE Program Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PATIENT INTRODUCTORY BROCHURE.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","854","Isotretinoin Educational Kit for Males and Females of Nonchildbearing Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_ISOTRETINOIN EDUCATIONAL KIT FOR MALE PATIENTS AND FEMALE PATIENTS WHO CANNOT GET PREGNANT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","855","Isotretinoin Educational Kit for Females of Childbearing Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_ISOTRETINOIN EDUCATIONAL KIT FOR FEMALES WHO CAN GET PREGNANT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","856","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PATIENT INFORMATION INFORMED CONSENT (FOR ALL PATIENTS).pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","857","Patient Information/Informed Consent for Females of Childbearing Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PATIENT INFORMATION INFORMED CONSENT ABOUT BIRTH DEFECTS (FOR FEMALE PATIENTS WHO CAN GET PREGNANT).pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","858","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PATIENT COMPREHENSION QUESTIONS.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","859","iPLEDGE wholesaler agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_WHOLESALER ACKNOWLEDGMENT FORM.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","860","Wholesaler 2 wholesaler shipment request form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_WHOLESALER TO WHOLESALER SHIPMENT REQUEST.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","861","ANNUAL IPLEDGE REPORT CONTENTS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_ANNUAL IPLEDGE REPORT CONTENTS.pdf" "37","Mycophenolate","209","09/27/2013","862","Mycophenolate REMS Brochure for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_BROCHURE FOR HEALTHCARE PROVIDER.pdf" "37","Mycophenolate","209","09/27/2013","863","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_PATIENT PRESCRIBER ACKNOWLEDGMENT FORM.pdf" "37","Mycophenolate","209","09/27/2013","864","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_PRESCRIBER TRAINING CONFIRMATION FORM.pdf" "37","Mycophenolate","209","09/27/2013","865","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_CENTER TRAINING CONFIRMATION FORM.pdf" "37","Mycophenolate","209","09/27/2013","866","DHCP Letter for Centers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_DEAR CENTER DIRECTOR LETTER.pdf" "37","Mycophenolate","209","09/27/2013","867","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_JOURNAL INFORMATION PIECE.pdf" "37","Mycophenolate","209","09/27/2013","868","DHCP Introductory Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_DEAR HEALTHCARE PROVIDER LETTER.pdf" "37","Mycophenolate","209","09/27/2013","869","Obstetrician/Gynecologist Referral Template Letters for Contraception Counseling","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_OB GYN CONTRACEPTION COUNSELING LETTER.pdf" "37","Mycophenolate","209","09/27/2013","870","Obstetrician/Gynecologist Referral Template Letters for Preconception Counseling","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_OB GYN PRECONCEPTION COUNSELING LETTER.pdf" "37","Mycophenolate","209","09/27/2013","871","Mycophenolate REMS Overview for Patients and Your Birth Control Options","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_OVERVIEW & YOUR BIRTH CONTROL OPTIONS BOOKLET.pdf" "37","Mycophenolate","209","09/27/2013","872","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_PREGNANCY REGISTRY FREQUENTLY ASKED QUESTIONS FOR PATIENTS.pdf" "37","Mycophenolate","209","09/27/2013","873","Mycophenolate REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_REMS WEBSITE.pdf" "47","Rosiglitazone","739","05/07/2014","874","Training Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_TRAINING SLIDE DECK.pdf" "47","Rosiglitazone","739","05/07/2014","875","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_DEAR HEALTHCARE PROVIDER LETTER.pdf" "47","Rosiglitazone","739","05/07/2014","876","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_DEAR PROFESSIONAL SOCIETY LETTER.pdf" "47","Rosiglitazone","739","05/07/2014","877","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_REMS WEBSITE.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","878","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_DEAR HEALTHCARE PROVIDER LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","879","Dear Pharmacy Letters (Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_DEAR OUTPATIENT PHARMACY LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","880","Dear Pharmacy Letters (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_DEAR INPATIENT PHARMACY LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","881","Dear Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_DEAR DISTRIBUTOR LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","882","Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_WHOLESALER DISTRIBUTOR ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","883","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PRESCRIBER ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","884","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PATIENT PRESCRIBER AGREEMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","885","TIRF REMS Access Patient and Caregiver Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR PATIENTS AND CAREGIVERS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","886","TIRF REMS Access Prescriber Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR PRESCRIBERS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","887","The TIRF REMS Access Program Overview (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR INDEPENDENT OUTPATIENT PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","888","The TIRF REMS Access Program Overview (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR CHAIN OUTPATIENT PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","889","The TIRF REMS Access Program Overview (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR CLOSED SYSTEM OUTPATIENT PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","890","The TIRF REMS Access Program Overview (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_PROGRAM OVERVIEW FOR INPATIENT PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","891","TIRF REMS Access Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_EDUCATION PROGRAM FOR PRESCRIBERS AND PHARMACISTS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","892","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_KNOWLEDGE ASSESSMENT.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","893","Pharmacy Enrollment Form (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_INDEPENDENT OUTPATIENT PHARMACY ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","894","Pharmacy Enrollment Form (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_CHAIN OUTPATIENT PHARMACY ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","895","Pharmacy Enrollment Form (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_CLOSED SYSTEM OUTPATIENT PHARMACY ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","896","Pharmacy Enrollment Form (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_INPATIENT PHARMACY ENROLLMENT FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","897","Frequently Asked Questions (FAQs)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_FREQUENTLY ASKED QUESTIONS (FAQs).pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","898","TIRF REMS Access Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_REMS WEBSITE.pdf" "43","Prolia","745","06/16/2014","899","DHCP Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2014-06-16_dear_healthcare_professional_letter.pdf" "43","Prolia","745","06/16/2014","900","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2014-06-16_Medication_Guide.pdf" "39","Nulojix","94","06/15/2011","901","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_Journal Information Piece.pdf" "66","Victoza","760","07/31/2014","902","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS SLIDES.pdf" "66","Victoza","760","07/31/2014","903","The REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS LETTER FOR PROFESSIONAL SOCIETIES (PRINT VERSION).pdf" "66","Victoza","760","07/31/2014","904","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS WEBSITE (LANDING PAGE).pdf" "66","Victoza","760","07/31/2014","905","The REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS FACTSHEET.pdf" "66","Victoza","760","07/31/2014","906","The REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS LETTER FOR HEALTHCARE PROVIDERS (PRINT VERSION).pdf" "62","Truvada","748","06/18/2014","908","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_REMS WEBSITE.pdf" "49","Soliris","735","04/30/2014","909","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_MEDICATION GUIDE.pdf" "49","Soliris","735","04/30/2014","910","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-04-30_PATIENT SAFETY CARD.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","912","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Patient_Counseling_Document_(PCD)_on_Extended_Release_Long_Acting_Opioid Analgesics.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","913","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_FDA_Blueprint_for_ Prescriber_Education_for_Extended_Release_and_Long_Acting_Opioid_Analgesics.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","914","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Prescriber Letter 1.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","915","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Prescriber Letter 2.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","916","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Prescriber Letter 3.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","917","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Professional_Organization_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","918","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Professional_Organization_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","919","ER/LA Opioid Analgesic REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_ERLA Opioid Analgesic REMS website.pdf" "14","Eliquis","764","08/12/2014","920","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2014-08-12_DEAR_HEALTHCARE_PROFESSIONAL_LETTER.pdf" "14","Eliquis","764","08/12/2014","921","Professional Organization Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2014-08-12_PROFESSIONAL_ORGANIZATION_LETTER.pdf" "14","Eliquis","764","08/12/2014","922","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2014-08-12_ELIQUIS_REMS_WEBSITE.pdf" "322","Trulicity","771","09/18/2014","923","REMS factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS factsheet.pdf" "322","Trulicity","771","09/18/2014","924","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS full.pdf" "322","Trulicity","771","09/18/2014","925","REMS Letter for Healthcare Providers email format","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS Letter for Healthcare Providers email format.pdf" "322","Trulicity","771","09/18/2014","926","REMS Letter for Healthcare Providers print format","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS Letter for Healthcare Providers print format.pdf" "322","Trulicity","771","09/18/2014","927","REMS Letter for Professional Societies email format","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS Letter for Professional Societies email format.pdf" "322","Trulicity","771","09/18/2014","928","REMS Letter for Professional Societies print format","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS Letter for Professional Societies print format.pdf" "322","Trulicity","771","09/18/2014","929","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS website.pdf" "322","Trulicity","771","09/18/2014","930","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2014-09-18_REMS_document.pdf" "49","Soliris","772","10/10/2014","931","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Dosing and Administration Guide.pdf" "49","Soliris","772","10/10/2014","933","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Patient Safety Brochure, Important Safety Information about Soliris.pdf" "49","Soliris","772","10/10/2014","934","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Prescriber Introductory Letter and Enrollment Form.pdf" "49","Soliris","772","10/10/2014","935","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Prescriber Safety Brochure, Important Safety Information about Soliris.pdf" "49","Soliris","772","10/10/2014","936","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_REMS document.pdf" "49","Soliris","772","10/10/2014","937","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_REMS full.pdf" "49","Soliris","772","10/10/2014","938","Soliris Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Soliris Patient Safety Card.pdf" "49","Soliris","772","10/10/2014","939","Soliris REMS website (SolirisREMS.com) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2014-10-10_Soliris REMS website (SolirisREMS.com).pdf" "41","Pomalyst","767","09/12/2014","940","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Celgene REMS Programs Pharmacy Training.pdf" "41","Pomalyst","767","09/12/2014","941","Celgene Risk Management.com Website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Celgene Risk Management.com website.pdf" "41","Pomalyst","767","09/12/2014","942","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Education and Counseling Checklist for Pharmacies_formatted.pdf" "41","Pomalyst","767","09/12/2014","943","Patient Guide to POMALYST REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient Guide to POMALYST REMS™ Program.pdf" "41","Pomalyst","767","09/12/2014","944","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient Prescription Form (Veterans Administration).pdf" "41","Pomalyst","767","09/12/2014","945","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient Prescription Form.pdf" "41","Pomalyst","767","09/12/2014","946","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient Survey Reminder Card_formatted.pdf" "41","Pomalyst","767","09/12/2014","947","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant.pdf" "41","Pomalyst","767","09/12/2014","948","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant.pdf" "41","Pomalyst","767","09/12/2014","949","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant.pdf" "41","Pomalyst","767","09/12/2014","950","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant.pdf" "41","Pomalyst","767","09/12/2014","951","Patient-Physician Agreement Form for Adult Males","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for Adult Males.pdf" "41","Pomalyst","767","09/12/2014","952","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Patient-Physician Agreement Form for Male Child.pdf" "41","Pomalyst","767","09/12/2014","953","Pharmacy Certification Quiz (the POMALYST REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Pharmacy Certification Quiz (the POMALYST REMS™ Program).pdf" "41","Pomalyst","767","09/12/2014","954","POMALYST REMS™ At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_POMALYST REMS™ At-A-Glance_formatted.pdf" "41","Pomalyst","767","09/12/2014","955","POMALYST REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_POMALYST REMS™ Patient Resource Pack Envelope_formatted.pdf" "41","Pomalyst","767","09/12/2014","956","POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program education and prescribing safety kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program education and prescribing safety kit_formatted.pdf" "41","Pomalyst","767","09/12/2014","957","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Prescriber Enrollment Form_formatted.pdf" "41","Pomalyst","767","09/12/2014","958","Prescriber Guide to POMALYST REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Prescriber Guide to POMALYST REMS™ Program_formatted.pdf" "41","Pomalyst","767","09/12/2014","959","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_REMS document.pdf" "41","Pomalyst","767","09/12/2014","960","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_REMS full.pdf" "41","Pomalyst","767","09/12/2014","961","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2014-09-12_Welcome Letter.pdf" "45","Qsymia","768","09/26/2014","962","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia _2014-09-26_Full REMS.pdf" "45","Qsymia","768","09/26/2014","963","Risk of Birth Defects with Qsymia Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Risk of Birth Defects with Qsymia Patient Brochure.pdf" "45","Qsymia","768","09/26/2014","964","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_REMS document.pdf" "45","Qsymia","768","09/26/2014","965","QsymiaREMS.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_QsymiaREMS.com.pdf" "45","Qsymia","768","09/26/2014","966","Print Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Print Qsymia REMS Pharmacy Training Module.pdf" "45","Qsymia","768","09/26/2014","967","Print Qsymia REMS HCP Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Print Qsymia REMS HCP Training Program.pdf" "45","Qsymia","768","09/26/2014","968","Prescriber Dosing and Management Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Prescriber Dosing and Management Checklist.pdf" "45","Qsymia","768","09/26/2014","969","Pharmacy Enrollment Form - Mail Order Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Pharmacy Enrollment Form - Mail Order Pharmacy.pdf" "45","Qsymia","768","09/26/2014","970","Pharmacy Enrollment Form - Independent Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Pharmacy Enrollment Form - Independent Pharmacy.pdf" "45","Qsymia","768","09/26/2014","971","Pharmacy Enrollment Form - Corporate Entity of Retail Chain Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Pharmacy Enrollment Form - Corporate Entity of Retail Chain Pharmacy.pdf" "45","Qsymia","768","09/26/2014","972","Online Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Online Qsymia REMS Pharmacy Training Module.pdf" "45","Qsymia","768","09/26/2014","973","Online Qsymia REMS HCP Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Online Qsymia REMS HCP Training Program.pdf" "45","Qsymia","768","09/26/2014","974","Healthcare Provider Counseling Tool for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Healthcare Provider Counseling Tool for Females of Reproductive Potential.pdf" "45","Qsymia","768","09/26/2014","975","Dear Medical Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Dear Medical Society Letter.pdf" "45","Qsymia","768","09/26/2014","976","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2014-09-26_Dear Healthcare Provider Letter.pdf" "46","Revlimid","769","09/12/2014","977","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Celgene REMS Programs Pharmacy Training.pdf" "46","Revlimid","769","09/12/2014","978","Celgene Risk Management.com website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Celgene Risk Management.com website.pdf" "46","Revlimid","769","09/12/2014","979","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Education and Counseling Checklist for Pharmacies_formatted.pdf" "46","Revlimid","769","09/12/2014","980","Patient Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient Guide to REVLIMID REMS™ Program_formatted.pdf" "46","Revlimid","769","09/12/2014","981","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient Prescription Form (Veterans Administration).pdf" "46","Revlimid","769","09/12/2014","982","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient Prescription Form.pdf" "46","Revlimid","769","09/12/2014","983","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient Survey Reminder Card_formatted.pdf" "46","Revlimid","769","09/12/2014","984","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant.pdf" "46","Revlimid","769","09/12/2014","985","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant.pdf" "46","Revlimid","769","09/12/2014","986","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Adult Male.pdf" "46","Revlimid","769","09/12/2014","987","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Female Child Who Can Get Pregnant.pdf" "46","Revlimid","769","09/12/2014","988","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant.pdf" "46","Revlimid","769","09/12/2014","989","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Patient-Physician Agreement Form for Male Child.pdf" "46","Revlimid","769","09/12/2014","990","Pharmacy Certification Quiz (the REVLIMID REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Pharmacy Certification Quiz (the REVLIMID REMS™ Program).pdf" "46","Revlimid","769","09/12/2014","991","Pharmacy Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Pharmacy Guide to REVLIMID REMS™ Program.pdf" "46","Revlimid","769","09/12/2014","992","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Prescriber Enrollment Form_formatted.pdf" "46","Revlimid","769","09/12/2014","993","Prescriber Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Prescriber Guide to REVLIMID REMS™ Program_formatted.pdf" "46","Revlimid","769","09/12/2014","994","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_REMS document.pdf" "46","Revlimid","769","09/12/2014","995","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_REMS full.pdf" "46","Revlimid","769","09/12/2014","996","REVLIMID REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_REVLIMID REMS At-A-Glance_formatted.pdf" "46","Revlimid","769","09/12/2014","997","REVLIMID REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_REVLIMID REMS™ Patient Resource Pack Envelope.pdf" "46","Revlimid","769","09/12/2014","998","REVLIMID Risk Evaluation and Mitgation Strategy (REMS)™ Program Education and Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_REVLIMID Risk Evaluation and Mitgation Strategy (REMS)™ Program Education and Safety Kit_formatted.pdf" "46","Revlimid","769","09/12/2014","999","Welcome letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2014.09.12_Welcome letter.pdf" "58","Thalomid","770","09/12/2014","1000","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","770","09/12/2014","1001","Celgene Risk Management.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Celgene_Risk_Management.com_website.pdf" "58","Thalomid","770","09/12/2014","1002","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Education_and_Counseling_Checklist_for_Pharmacies_formatted.pdf" "58","Thalomid","770","09/12/2014","1003","Patient Guide to THALOMID REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient_Guide_to_THALOMID_REMS_Program_formatted.pdf" "58","Thalomid","770","09/12/2014","1004","Patient Prescription Form (Veterans Administration","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient_Prescription_Form_(Veterans Administration).pdf" "58","Thalomid","770","09/12/2014","1005","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient_Survey_Reminder_Card_formatted.pdf" "58","Thalomid","770","09/12/2014","1006","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","770","09/12/2014","1007","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","770","09/12/2014","1008","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","770","09/12/2014","1009","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","770","09/12/2014","1010","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_for_Adult_Male.pdf" "58","Thalomid","770","09/12/2014","1011","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Patient-Physician_Agreement_Form_for_Male_Child.pdf" "58","Thalomid","770","09/12/2014","1012","Pharmacy Certification Quiz (the THALOMID REMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Pharmacy_Certification_Quiz_(the_THALOMID_REMS_Program).pdf" "58","Thalomid","770","09/12/2014","1013","Pharmacy Guide to the THALOMID REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Pharmacy_Guide_to_the_THALOMID_REMS_Program.pdf" "58","Thalomid","770","09/12/2014","1014","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Prescriber_Enrollment_Form_formatted.pdf" "58","Thalomid","770","09/12/2014","1015","Prescriber Guide to THALOMID REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Prescriber_Guide_to_THALOMID_REMS_Program.pdf" "58","Thalomid","770","09/12/2014","1016","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_REMS_document.pdf" "58","Thalomid","770","09/12/2014","1017","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_REMS_full.pdf" "58","Thalomid","770","09/12/2014","1018","THALOMID REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_THALOMID_REMS_At-A-Glance_formatted.pdf" "58","Thalomid","770","09/12/2014","1019","THALOMID REMS Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_THALOMID_REMS_Patient_Resource_Pack_Envelope_formatted.pdf" "58","Thalomid","770","09/12/2014","1020","THALOMID Risk Evaluation and Mitigation Strategy (REMS) Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_THALOMID_Risk_Evaluation_and_Mitigation_Strategy_(REMS)_Program_Education_and_Prescribing_Safety_Kit_formatted.pdf" "58","Thalomid","770","09/12/2014","1021","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2014.09.12_Welcome_Letter.pdf" "2","Adasuve","324","12/09/2013","1022","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_REMS DOCUMENT.pdf" "2","Adasuve","324","12/09/2013","1023","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_13-12-09_Full.pdf" "6","Aranesp","325","12/31/2013","1024","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_REMS DOCUMENT.pdf" "6","Aranesp","325","12/31/2013","1025","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aranesp_2013-12-31_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","1026","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2013-09-04_Full.pdf" "11","Caprelsa","183","11/27/2013","1028","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_Full.pdf" "11","Caprelsa","183","11/27/2013","1029","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2013-11-27_REMS DOCUMENT.pdf" "313","Aveed","723","03/05/2014","1031","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_Full.pdf" "313","Aveed","723","03/05/2014","1032","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS DOCUMENT.pdf" "15","Entereg","184","10/18/2013","1033","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_REMS DOCUMENT.pdf" "15","Entereg","184","10/18/2013","1034","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2013-10-18_Full.pdf" "16","Epogen / Procrit","326","12/31/2013","1035","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_REMS DOCUMENT.pdf" "16","Epogen / Procrit","326","12/31/2013","1036","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/EpogenProcrit_2013-12-31_Full.pdf" "17","Opioid Analgesic REMS","765","08/19/2014","1038","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2014-08-19_Full.pdf" "18","Extraneal","710","02/25/2014","1039","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2014-02-25_Full.pdf" "18","Extraneal","710","02/25/2014","1041","Extraneal Patient Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2014-02-25_Extraneal Patient Kit.pdf" "18","Extraneal","710","02/25/2014","1042","Extraneal PD Nurse Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2014-02-25_Extraneal PD Nurse Training Tool .pdf" "18","Extraneal","710","02/25/2014","1043","EXTRANEAL Patient Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2014-02-25_Patient Training Tool.pdf" "18","Extraneal","710","02/25/2014","1044","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2014-02-25_REMS DOCUMENT .pdf" "21","Gattex","754","06/26/2014","1045","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_Full.pdf" "21","Gattex","754","06/26/2014","1046","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2014-06-26_REMS DOCUMENT.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","1047","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_Full.pdf" "24","Isotretinoin iPLEDGE","208","04/12/2012","1048","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_REMS DOCUMENT.pdf" "25","Juxtapid","187","08/13/2013","1050","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_Full.pdf" "25","Juxtapid","187","08/13/2013","1051","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2013-08-13_REMS DOCUMENT.pdf" "27","Kynamro","737","05/07/2014","1052","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_Full.pdf" "27","Kynamro","737","05/07/2014","1053","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2014-05-07_REMS DOCUMENT.pdf" "28","Letairis","700","01/31/2014","1054","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_Full.pdf" "28","Letairis","700","01/31/2014","1055","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_REMS DOCUMENT.pdf" "29","Lotronex","738","05/08/2014","1056","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_Full.pdf" "29","Lotronex","738","05/08/2014","1057","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2014-05-08_REMS DOCUMENT.pdf" "35","Mifeprex","83","06/08/2011","1058","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_Full.pdf" "35","Mifeprex","83","06/08/2011","1059","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_REMS DOCUMENT.pdf" "314","Myalept","755","06/30/2014","1060","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_Full.pdf" "314","Myalept","755","06/30/2014","1061","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2014-06-30_REMS DOCUMENT.pdf" "37","Mycophenolate","209","09/27/2013","1062","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_Full.pdf" "37","Mycophenolate","209","09/27/2013","1063","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2013-09-27_REMS DOCUMENT.pdf" "76","Opsumit","191","10/18/2013","1065","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_Full.pdf" "76","Opsumit","191","10/18/2013","1066","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2013-10-18_REMS DOCUMENT.pdf" "47","Rosiglitazone","739","05/07/2014","1067","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_Full.pdf" "47","Rosiglitazone","739","05/07/2014","1068","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rosiglitazone_2014-05-07_REMS DOCUMENT.pdf" "48","Sabril","195","10/26/2013","1069","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_Full.pdf" "48","Sabril","195","10/26/2013","1070","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2013-10-26_REMS DOCUMENT.pdf" "52","Suboxone sublingual film","731","04/28/2014","1071","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_Full.pdf" "52","Suboxone sublingual film","731","04/28/2014","1072","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual film_2014-04-28_REMS DOCUMENT.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","1073","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_Full.pdf" "315","Suboxone sublingual tablets","733","12/22/2011","1074","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone sublingual tablets_2011-12-22_REMS DOCUMENT.pdf" "53","Subutex","124","12/22/2011","1075","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_Full.pdf" "53","Subutex","124","12/22/2011","1076","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Subutex_2011-12-22_REMS DOCUMENT.pdf" "59","Tikosyn","198","12/06/2013","1077","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06-Full.pdf" "59","Tikosyn","198","12/06/2013","1078","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2013-12-06_REMS DOCUMENT.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","1079","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","1080","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2013-11-07_REMS DOCUMENT.pdf" "61","Tracleer","199","07/01/2013","1081","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_Full.pdf" "61","Tracleer","199","07/01/2013","1082","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_REMS DOCUMENT .pdf" "62","Truvada","748","06/18/2014","1083","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_Full.pdf" "62","Truvada","748","06/18/2014","1084","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2014-06-18_REMS DOCUMENT.pdf" "63","Tysabri","330","12/15/2013","1085","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_Full.pdf" "63","Tysabri","330","12/15/2013","1086","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2013-12-15_REMS DOCUMENT.pdf" "64","Versacloz","201","12/05/2013","1087","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_Full.pdf" "64","Versacloz","201","12/05/2013","1088","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Versacloz_2013-12-06_REMS DOCUMENT.pdf" "71","Xiaflex","206","12/06/2013","1089","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_Full.pdf" "71","Xiaflex","206","12/06/2013","1090","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2013-12-06_REMS DOCUMENT.pdf" "74","Zyprexa Relprevv","167","03/27/2013","1091","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_Full.pdf" "74","Zyprexa Relprevv","167","03/27/2013","1092","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2013-03-27_REMS DOCUMENT.pdf" "12","Chantix","773","10/15/2014","1093","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Chantix_2014-10-15_REMS document .pdf" "28","Letairis","774","10/29/2014","1094","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.pdf" "28","Letairis","774","10/29/2014","1095","Letairis REMS Program Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Letairis REMS Program Guide for Females Who Can Get Pregnant.pdf" "28","Letairis","774","10/29/2014","1096","Letairis REMS Website Screenshot (www.letairisrems.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Letairis REMS website (www.letairisrems.com).pdf" "28","Letairis","774","10/29/2014","1098","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Patient Enrollment and Consent Form.pdf" "28","Letairis","774","10/29/2014","1099","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Prescriber Enrollment and Agreement Form.pdf" "28","Letairis","774","10/29/2014","1100","Prescriber Guide to the Letairis REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_Prescriber Guide to the Letairis REMS Program.pdf" "28","Letairis","774","10/29/2014","1101","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_REMS document.pdf" "28","Letairis","774","10/29/2014","1102","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-10-29_REMS full.pdf" "4","Androgel 1%","779","11/12/2014","1103","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Androgel 1%_2014-11-12_REMS DOCUMENT.pdf" "5","Androgel 1.62%","780","11/14/2014","1104","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Androgel 1.62%_2014-11-14_REMS document.pdf" "65","Vibativ","781","11/12/2014","1105","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vibativ_2014.11.12_REMS full.pdf" "340","Lemtrada","782","11/14/2014","1106","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_ LEMTRADA REMS Education Program for Prescribers.pdf" "340","Lemtrada","782","11/14/2014","1107","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA Patient Safety Information Card.pdf" "340","Lemtrada","782","11/14/2014","1108","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Education Program for Healthcare Facilities.pdf" "340","Lemtrada","782","11/14/2014","1109","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Healthcare Facility Enrollment Form.pdf" "340","Lemtrada","782","11/14/2014","1110","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Infusion Checklist.pdf" "340","Lemtrada","782","11/14/2014","1111","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Knowledge Assessment.pdf" "340","Lemtrada","782","11/14/2014","1112","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Patient Authorization and Baseline Lab Form.pdf" "340","Lemtrada","782","11/14/2014","1113","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Patient Enrollment Form.pdf" "340","Lemtrada","782","11/14/2014","1114","Patient Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Patient Reminder Letter.pdf" "340","Lemtrada","782","11/14/2014","1115","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Patient Status Form.pdf" "340","Lemtrada","782","11/14/2014","1116","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Patient Status Reminder Letter.pdf" "340","Lemtrada","782","11/14/2014","1117","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Pharmacy Enrollment Form.pdf" "340","Lemtrada","782","11/14/2014","1118","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS prescriber enrollment form.pdf" "340","Lemtrada","782","11/14/2014","1119","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Prescription Ordering Form.pdf" "340","Lemtrada","782","11/14/2014","1120","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_LEMTRADA REMS Program Overview.pdf" "340","Lemtrada","782","11/14/2014","1121","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_REMS document.pdf" "340","Lemtrada","782","11/14/2014","1122","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_REMS full.pdf" "340","Lemtrada","782","11/14/2014","1123","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_REMS Letter for Healthcare Providers (print and email versions).pdf" "340","Lemtrada","782","11/14/2014","1124","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_The LEMTRADA REMS Website.pdf" "340","Lemtrada","782","11/14/2014","1125","What You Need to Know About LEMTRADA Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_What You Need to Know About LEMTRADA Treatment A Patient Guide.pdf" "340","Lemtrada","782","11/14/2014","1126","LEMTRADA Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2014.11.14_What You Need to Know about LEMTRADA Treatment and Infusion Reactions A Patient Guide.pdf" "341","Blincyto","783","12/03/2014","1127","BLINCYTO REMS Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_BLINCYTO REMS Fact Sheet for Providers.pdf" "341","Blincyto","783","12/03/2014","1128","BLINCYTO REMS Website (landing page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_BLINCYTO REMS Website (landing page).pdf" "341","Blincyto","783","12/03/2014","1129","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_REMS document.pdf" "341","Blincyto","783","12/03/2014","1130","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_REMS full.pdf" "341","Blincyto","783","12/03/2014","1131","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_REMS Letter for Healthcare Providers (email and print versions).pdf" "341","Blincyto","783","12/03/2014","1132","REMS Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_REMS Letter for Hospital and Home Healthcare Pharmacists (email and print versions).pdf" "341","Blincyto","783","12/03/2014","1133","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2014.12.03_REMS Letter for Professional Societies (email and print versions).pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1134","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_APPROPRIATE USE CHECKLIST .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1135","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_DEAR PHARMACIST LETTER.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1136","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_DEAR PRESCRIBER LETTER .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1137","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_FULL.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1138","Pharmacists Brochure, Office-Based Buprenorphine Therapy for Opioid Dependence Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_PHARMACISTS BROCHURE, OFFICE-BASED BURPENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PHARMACISTS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1139","Prescriber Brochure, Office-Based Burprenorphine Therapy for Opioid Dependence Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_PRESCRIBER BROCHURE, OFFICE-BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PRESCRIBERS .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1140","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06_REMS DOCUMENT .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","1141","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2014-06-06-REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1142","FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_FDA BLUEPRINT FOR PRESCRIBER EDUCATION.pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1143","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_FULL.pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1144","Patient Counseling Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PATIENT COUNSELING DOCUMENT (PCD).pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1145","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PRESCRIBER LETTER1.pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1146","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PRESCRIBER LETTER2 .pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1147","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PRESCRIBER LETTER3 .pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1148","Professional Organization Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER1 .pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1149","Professional Organization Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER2.pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1150","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","784","11/20/2014","1151","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-11-20_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1152","FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_FDA BLUEPRINT FOR PRESCRIBER EDUCATION.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1153","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_FULL.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1154","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PATIENT COUNSELING DOCUMENT (PCD).pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1155","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PRESCRIBER LETTER 1.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1156","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PRESCRIBER LETTER 2.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1157","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PRESCRIBER LETTER 3.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1158","Professional Organization Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1159","Professional Organization Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1160","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_REMS DOCUMENT.pdf" "17","Opioid Analgesic REMS","790","12/29/2014","1161","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-12-29_REMS WEBSITE.pdf" "342","Saxenda","789","12/23/2014","1162","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_FULL.pdf" "342","Saxenda","789","12/23/2014","1163","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS DOCUMENT .pdf" "342","Saxenda","789","12/23/2014","1164","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS FACTSHEET .pdf" "342","Saxenda","789","12/23/2014","1165","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS LETTER FOR HEALTHCARE PROVIDERS .pdf" "342","Saxenda","789","12/23/2014","1166","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS LETTER FOR PROFESSIONAL SOCIETIES .pdf" "342","Saxenda","789","12/23/2014","1167","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS SLIDES.pdf" "342","Saxenda","789","12/23/2014","1168","REMS Website (Landing Page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2014-12-23_REMS WEBSITE (LANDING PAGE) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1169","Dear Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_DEAR DISTRIBUTOR LETTER .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1170","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_DEAR HEALTHCARE PROVIDER LETTER .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1171","Dear Pharmacy Letter (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_DEAR PHARMACY LETTER (INPATIENT) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1172","Dear Pharmacy Letter (Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_DEAR PHARMACY LETTERS (OUTPATIENT) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1173","Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_DISTRIBUTOR ENROLLMENT FORM .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1174","Frequently Asked Questions (FAQs)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_FREQUENTLY ASKED QUESTIONS (FAQS) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1175","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_FULL.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1176","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_KNOWLEDGE ASSESSMENT .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1177","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PATIENT PRESCRIBER AGREEMENT FORM .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1178","Pharmacy Enrollment Form (Chain Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PHARMACY ENROLLMENT FORM (CHAIN OUTPATIENT).pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1179","Pharmacy Enrollment Form (Closed System Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PHARMACY ENROLLMENT FORM (CLOSED SYSTEM OUTPATIENT).pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1180","Pharmacy Enrollment Form (Independent Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PHARMACY ENROLLMENT FORM (INDEPENDENT OUTPATIENT).pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1181","Pharmacy Enrollment Form (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PHARMACY ENROLLMENT FORM (INPATIENT PHARMACY).pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1182","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_PRESCRIBER ENROLLMENT FORM .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1183","REMS Access Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS WEBSITE .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1184","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_REMS DOCUMENT .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1185","TIRF REMS Access Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS EDUCATION PROGRAM .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1186","TIRF REMS Access Patient and Caregiver Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PATIENT AND CAREGIVER OVERVIEW .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1187","TIRF REMS Access Prescriber Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PRESCRIBER PROGRAM OVERVIEW .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1188","TIRF REMS Access Program Overview (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PROGRAM OVERVIEW (CHAIN OUTPATIENT PHARMACIES) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1189","TIRF REMS Access Program Overview (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PROGRAM OVERVIEW (CLOSED SYSTEM OUTPATIENT PHARMACIES) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1190","TIRF REMS Access Program Overview (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PROGRAM OVERVIEW (INDEPENDENT OUTPATIENT PHARMACIES) .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","1191","TIRF REMS Access Program Overview (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2014-12-24_TIRF REMS ACCESS PROGRAM OVERVIEW (INPATIENT PHARMACIES).pdf" "74","Zyprexa Relprevv","785","10/30/2014","1192","Healthcare Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30 _HEALTHCARE PROFESSIONAL TRAINING .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1193","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30 _PATIENT REGISTRATION FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1194","Buy and Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_BUY AND BILL PHARMACY SERVICE PROVIDER REGISTRATION FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1195","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_FULL.pdf" "74","Zyprexa Relprevv","785","10/30/2014","1196","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_HEALTHCARE FACILITY REGISTRATION FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1197","Multiple Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_MULTIPLE PATIENT INJECTION FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1198","Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PATIENT CARE PROGRAM INSTRUCTIONS BROCHURE .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1199","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PHARMACY REGISTRATION FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1200","Post Injection Delirium Sedation Syndrome (PDSS) Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_POST INJECTION DELIRIUM SEDATION SYNDROME (PDSS) FORM .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1201","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PRESCRIBER REGISTRATION FORM.pdf" "74","Zyprexa Relprevv","785","10/30/2014","1202","Reconstitution and Administration Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_RECONSTITUTION AND ADMINISTRATION TRAINING.pdf" "74","Zyprexa Relprevv","785","10/30/2014","1203","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_REMS DOCUMENT .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1204","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_REMS WEBSITE .pdf" "74","Zyprexa Relprevv","785","10/30/2014","1205","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_SINGLE PATIENT INJECTION FORM .pdf" "149","Adempas","740","06/11/2014","1206","Patient Enrollment and Consent Form (VA Use Only)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_PATIENT ENROLLMENT AND CONSENT FORM (VA USE ONLY) .pdf" "149","Adempas","740","06/11/2014","1207","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_Full.pdf" "149","Adempas","740","06/11/2014","1208","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_REMS DOCUMENT.pdf" "343","Natpara","791","01/23/2015","1210","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Patient-Brochure.pdf" "343","Natpara","791","01/23/2015","1211","Patient-Prescriber Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Patient-Prescriber-Acknowledgment-Form.pdf" "343","Natpara","791","01/23/2015","1212","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Pharmacy-Enrollment-Form.pdf" "343","Natpara","791","01/23/2015","1213","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Prescriber-Enrollment-Form.pdf" "343","Natpara","791","01/23/2015","1214","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_REMS-document.pdf" "343","Natpara","791","01/23/2015","1215","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_REMS-full.pdf" "343","Natpara","791","01/23/2015","1216","Natpara REMS program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_REMS-Program-An-Introduction.pdf" "343","Natpara","791","01/23/2015","1217","Training Module for Pharmacy Representatives","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Training-Module-for-Pharmacy-Representatives.pdf" "343","Natpara","791","01/23/2015","1218","Training Module for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Training-Module-for-Prescribers.pdf" "343","Natpara","791","01/23/2015","1219","Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2015-01-23_Website.pdf" "1","Actemra","179","10/21/2013","1220","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_Full.pdf" "1","Actemra","179","10/21/2013","1221","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actemra_2013-10-21_REMS DOCUMENT.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1222","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_DEAR PRESCRIBER LETTER .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1223","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12 _DEAR PHARMACIST LETTER .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1224","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_APPROPRIATE USE CHECKLIST .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1225","Prescriber Brochure: “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PRESCRIBERS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1226","Pharmacist Brochure: "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_OFFICE BASED BUPRENORPHINE THERAPY FOR OPIOID DEPENDENCE IMPORTANT INFORMATION FOR PHARMACISTS .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1227","BTOD REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_REMS WEBSITE.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1228","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_FULL.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","1229","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-02-12_REMS DOCUMENT .pdf" "46","Revlimid","793","02/17/2015","1230","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PRESCRIBER ENROLLMENT FORM .pdf" "46","Revlimid","793","02/17/2015","1231","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PRESCRIPTION FORM .pdf" "46","Revlimid","793","02/17/2015","1232","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PRESCRIPTION FORM VETERANS ADMINISTRATION (VA) ONLY.pdf" "46","Revlimid","793","02/17/2015","1233","Prescriber Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PRESCRIBER GUIDE TO REMS PROGRAM .pdf" "46","Revlimid","793","02/17/2015","1234","REVLIMID REMS™ At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_AT A GLANCE .pdf" "46","Revlimid","793","02/17/2015","1235","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_WELCOME LETTER .pdf" "46","Revlimid","793","02/17/2015","1236","Celgene Risk Management.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_CELGENE RISK MANAGEMENT.COM WEBSITE .pdf" "46","Revlimid","793","02/17/2015","1237","Pharmacy Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PHARMACY GUIDE TO REMS PROGRAM .pdf" "46","Revlimid","793","02/17/2015","1238","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_REMS EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES .pdf" "46","Revlimid","793","02/17/2015","1239","Celgene REMS Programs Pharmacy Training: REVLIMID REMS™","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_CELGENE REMS PROGRAM PHARMACY TRAINING REVLIMID REMS .pdf" "46","Revlimid","793","02/17/2015","1240","Pharmacy Certification Quiz (the REVLIMID REMS™ Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17 PHARMACY CERTIFICATION QUIZ .pdf" "46","Revlimid","793","02/17/2015","1241","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM ADULT MALE .pdf" "46","Revlimid","793","02/17/2015","1242","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM MALE CHILD .pdf" "46","Revlimid","793","02/17/2015","1243","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM ADULT FEMALE WHO CAN NOT GET PREGNANT.pdf" "46","Revlimid","793","02/17/2015","1244","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM ADULT FEMALE WHO CAN GET PREGNANT .pdf" "46","Revlimid","793","02/17/2015","1245","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM FEMALE CHILD WHO CAN NOT GET PREGNANT .pdf" "46","Revlimid","793","02/17/2015","1246","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT PHYSICIAN AGREEMENT FORM FEMALE CHILD WHO CAN GET PREGNANT .pdf" "46","Revlimid","793","02/17/2015","1247","Patient Guide to REVLIMID REMS™ Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT GUIDE TO REVLIMID REMS PROGRAM .pdf" "46","Revlimid","793","02/17/2015","1248","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_EMERGENCY CONTRACEPTION BROCHURE .pdf" "46","Revlimid","793","02/17/2015","1249","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT SURVEY REMINDER CARD.pdf" "46","Revlimid","793","02/17/2015","1250","REVLIMID Risk Evaluation and Mitgation Strategy (REMS)™ Program Education and Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_REMS PROGRAM EDUCATION AND PRESCRIBING SAFETY KIT .pdf" "46","Revlimid","793","02/17/2015","1251","REVLIMID REMS™ Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_PATIENT RESOURCE PACK ENVELOPE .pdf" "46","Revlimid","793","02/17/2015","1252","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_REMS DOCUMENT .pdf" "46","Revlimid","793","02/17/2015","1253","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/REVLIMID_2015-02-17_FULL.pdf" "345","Xywav and Xyrem","796","02/27/2015","1254","XYREM REMS Program Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PRESCRIBER ENROLLMENT FORM .pdf" "345","Xywav and Xyrem","796","02/27/2015","1255","XYREM REMS Program Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PRESCRIBER BROCHURE .pdf" "345","Xywav and Xyrem","796","02/27/2015","1256","XYREM REMS Program Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PATIENT ENROLLMENT FORM .pdf" "345","Xywav and Xyrem","796","02/27/2015","1257","XYREM REMS Program Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PRESCRIPTION FORM .pdf" "345","Xywav and Xyrem","796","02/27/2015","1258","XYREM REMS Program Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PATIENT QUICK START GUIDE .pdf" "345","Xywav and Xyrem","796","02/27/2015","1259","XYREM REMS Program Website (www.XYREMREMS.com) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_REMS WEBSITE.pdf" "345","Xywav and Xyrem","796","02/27/2015","1260","XYREM REMS Program Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_CERTIFIED PHARMACY TRAINING PROGRAM.pdf" "345","Xywav and Xyrem","796","02/27/2015","1261","XYREM REMS Program Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_PATIENT COUNSELING CHECKLIST .pdf" "345","Xywav and Xyrem","796","02/27/2015","1263","XYREM REMS Program Risk Management Report Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_RISK MANAGEMENT REPORT FORM .pdf" "345","Xywav and Xyrem","796","02/27/2015","1264","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_REMS DOCUMENT .pdf" "345","Xywav and Xyrem","796","02/27/2015","1265","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_FULL.pdf" "43","Prolia","797","02/26/2015","1266","DHCP Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PROLIA_2015-02-26_DEAR HEALTHCARE PROVIDER LETTER .pdf" "43","Prolia","797","02/26/2015","1269","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PROLIA_2015-02-26_REMS DOCUMENT .pdf" "43","Prolia","797","02/26/2015","1270","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PROLIA_2015-02-26_FULL.pdf" "344","Farydak","795","02/23/2015","1271","REMS Letter to Healthcare Providers (print and email versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_DEAR HEALTHCARE PROVIDER LETTER (PRINT AND EMAIL VERSIONS) .pdf" "344","Farydak","795","02/23/2015","1272","REMS Letter for Professional Societies (print and email versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_DEAR PROFESSIONAL SOCIETIES LETTER (PRINT AND EMAIL VERSIONS) .pdf" "344","Farydak","795","02/23/2015","1273","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_FACTSHEET .pdf" "344","Farydak","795","02/23/2015","1274","The Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_JOURNAL INFORMATION PIECE .pdf" "344","Farydak","795","02/23/2015","1275","FARYDAK REMS Website Landing Page Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_REMS WEBSITE .pdf" "344","Farydak","795","02/23/2015","1276","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_REMS DOCUMENT .pdf" "344","Farydak","795","02/23/2015","1277","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_FULL.pdf" "319","Afrezza","798","04/20/2015","1278","Letter for Healthcare Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_Letter for Healthcare Providers (email version).pdf" "319","Afrezza","798","04/20/2015","1279","Letter for Healthcare Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_Letter for Healthcare Providers (print version).pdf" "319","Afrezza","798","04/20/2015","1280","Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_Letter for Professional Societies (print version).pdf" "319","Afrezza","798","04/20/2015","1281","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_REMS Factsheet.pdf" "319","Afrezza","798","04/20/2015","1282","REMS Website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_REMS Website screenshot.pdf" "319","Afrezza","798","04/20/2015","1283","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_REMS_document.pdf" "319","Afrezza","798","04/20/2015","1284","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2015.04.20_REMS_full.pdf" "319","Afrezza","798","04/20/2015","1285","Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aftrezza_2015.04.20_Letter for Professional Societies (email version).pdf" "41","Pomalyst","801","04/23/2015","1286","Celgene REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Celgene_REMS Programs_Pharmacy_Training.pdf" "41","Pomalyst","801","04/23/2015","1287","Celgene Risk Management.com website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Celgene_Risk Management.com_website_screenshot.pdf" "41","Pomalyst","801","04/23/2015","1288","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "41","Pomalyst","801","04/23/2015","1289","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","801","04/23/2015","1290","Patient Guide to Pomalyst REMS program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient_Guide_to_Pomalyst_REMS_program.pdf" "41","Pomalyst","801","04/23/2015","1291","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient_Prescription_Form.pdf" "41","Pomalyst","801","04/23/2015","1292","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient_Prescription_Form_(Veterans Administration).pdf" "41","Pomalyst","801","04/23/2015","1293","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient_Survey_Reminder_Card.pdf" "41","Pomalyst","801","04/23/2015","1294","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_ Agreement_Form_for_Adult_Female_Who Can_Not_Get_Pregnant.pdf" "41","Pomalyst","801","04/23/2015","1295","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_Agreement_Form_for_a_Female_Child_ Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","801","04/23/2015","1296","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_Agreement_Form_for_a_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","801","04/23/2015","1297","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","801","04/23/2015","1298","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_Agreement_Form_for_Adult_Male .pdf" "41","Pomalyst","801","04/23/2015","1299","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Patient-Physician_Agreement_Form_for_Male_Child.pdf" "41","Pomalyst","801","04/23/2015","1300","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Pharmacy_certification_quiz.pdf" "41","Pomalyst","801","04/23/2015","1301","Pharmacy Guide to the POMALYST REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Pharmacy_Guide.pdf" "41","Pomalyst","801","04/23/2015","1302","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_POMALYST_REMS_ Patient_Resource_Pack_Envelope.pdf" "41","Pomalyst","801","04/23/2015","1303","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Pomalyst_REMS_At-A-Glance.pdf" "41","Pomalyst","801","04/23/2015","1304","POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program education and prescribing safety kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Pomalyst_Risk_Evaluation_and_Mitigation_Strategy_(REMS)_program_education_and_prescribing_safety_kit.pdf" "41","Pomalyst","801","04/23/2015","1305","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Prescriber Enrollment Form.pdf" "41","Pomalyst","801","04/23/2015","1306","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Prescriber_Guide.pdf" "41","Pomalyst","801","04/23/2015","1307","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_REMS_document.pdf" "41","Pomalyst","801","04/23/2015","1308","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_REMS_full.pdf" "41","Pomalyst","801","04/23/2015","1309","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-04-23_Welcome_Letter.pdf" "346","Ionsys","802","04/30/2015","1310","Dear Healthcare Provider Letters","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_Dear_Healthcare_Provider_Letters.pdf" "346","Ionsys","802","04/30/2015","1311","Dear Hospital Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_Dear_Hospital_Pharmacy_Letter.pdf" "346","Ionsys","802","04/30/2015","1312","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_Hospital_Enrollment_Form.pdf" "346","Ionsys","802","04/30/2015","1313","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_Knowledge_Assessment.pdf" "346","Ionsys","802","04/30/2015","1314","REMS website mockups screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_REMS_website_screenshot.pdf" "346","Ionsys","802","04/30/2015","1315","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_REMS_document.pdf" "346","Ionsys","802","04/30/2015","1316","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_REMS_full.pdf" "346","Ionsys","802","04/30/2015","1317","Safety Brochure: Guide for Nurses and Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-04-30_Safety Brochure_Guide_for_Nurses_and_Pharmacists.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1318","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Dear Pharmacist Letter.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1319","Enrollment Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Enrollment Letter.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1320","Patient Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Patient Acknowledgment Form.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1321","Patient Follow-Up Survey Pre-Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Patient Follow-Up Survey Pre-Enrollment Form.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1322","Pharmacist Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Pharmacist Education Slide Deck.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1323","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Prescriber Education Slide Deck.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1324","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Prescriber Enrollment Form.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1325","Prescriber Enrollment Kit Overview Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Prescriber Enrollment Kit Overview Letter.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1326","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_REMS document.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1327","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_REMS full.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1328","REMS website for Pharmacists Section web screen shots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_REMS website mockups screenshot.pdf" "347","Alosetron (moved to shared system, do not use)","803","05/04/2015","1329","Stickers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2015.05.04_Stickers.pdf" "4","Androgel 1%","804","05/11/2015","1330","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Androgel_1_2015.05.11_REMS_document.pdf" "5","Androgel 1.62%","807","05/11/2015","1331","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Androgel_1.62_2015.05.11_REMS_document.pdf" "7","Axiron","808","05/11/2015","1332","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2015.05.11_REMS_document.pdf" "20","Fortesta","806","05/11/2015","1333","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fortesta_2015.05.11_REMS_document.pdf" "56","Testim","805","05/11/2015","1334","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testim_2015.05.11_REMS_document.pdf" "57","testosterone (NDA 202763)","809","05/11/2015","1335","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone (NDA 202763)_2015.05.11_REMS_document.pdf" "317","testosterone (NDA 203098)","810","05/11/2015","1336","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone (NDA 203098)_2015.05.11_REMS_document.pdf" "318","Vogelxo","751","06/04/2014","1337","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vogelxo_2015.05.11_REMS_document.pdf" "63","Tysabri","812","05/12/2015","1338","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_REMS DOCUMENT .pdf" "63","Tysabri","812","05/12/2015","1339","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_Full.pdf" "63","Tysabri","812","05/12/2015","1340","Guidance for evaluation of new neurological symptoms in patients receiving TYSABRI","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_GUIDANCE FOR EVALUATION OF NEW NEUROLOGICAL SYMPTOMS IN PATIENTS RECEIVING TYSABRI.pdf" "63","Tysabri","812","05/12/2015","1341","Patient/Prescriber Enrollment Form-MS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_PRESCRIBER PATIENT ENROLLMENT FORM - MS .pdf" "63","Tysabri","812","05/12/2015","1342","Patient Status Report and Reauthorization Questionnaire-MS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_PATIENT STATUS REPORT AND REAUTHORIZATION QUESTIONNAIRE - MS .pdf" "63","Tysabri","812","05/12/2015","1343","Initial Discontinuation Questionnaire-MS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_INITIAL DISCONTINUATION QUESTIONNAIRE-MS .pdf" "63","Tysabri","812","05/12/2015","1344","6-Month Discontinuation Questionnaire-MS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_6 MONTHS DISCONTINUATION QUESTIONNAIRE - MS.pdf" "63","Tysabri","812","05/12/2015","1345","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_UNDERSTANDING PML FOR GASTROENTEROLOGISTS.pdf" "63","Tysabri","812","05/12/2015","1346","Prescriber/Patient Enrollment Form-CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_PRESCRIBER PATIENT ENROLLMENT FORM CROHNS DISEASE .pdf" "63","Tysabri","812","05/12/2015","1347","Patient Status Report and Reauthorization Questionnaire-CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_PATIENT STATUS REPORT AND REAUTHORIZATION QUESTIONNAIRE-CROHNS DISEASE .pdf" "63","Tysabri","812","05/12/2015","1348","12-Week Questionnaire for CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_12 WEEK QUESTIONNAIRE FOR CROHNS DISEASE .pdf" "63","Tysabri","812","05/12/2015","1349","Initial Discontinuation Questionnaire-CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_INITIAL DISCONTINUATION QUESTIONNAIRE - CROHNS DISEASE .pdf" "63","Tysabri","812","05/12/2015","1350","6-Month Discontinuation Questionnaire-CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_6 MONTH DISCONTINUATION QUESTIONNAIRE-CROHNS DISEASE .pdf" "63","Tysabri","812","05/12/2015","1351","Change Prescriber Authorization","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_CHANGE PRESCRIBER AUTHORIZATION FORM .pdf" "63","Tysabri","812","05/12/2015","1352","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_INFUSION SITE ENROLLMENT FORM.pdf" "63","Tysabri","812","05/12/2015","1353","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_PRE INFUSION PATIENT CHECKLIST .pdf" "63","Tysabri","812","05/12/2015","1354","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_CERTIFIED PHARMACY ENROLLMENT FORM .pdf" "63","Tysabri","812","05/12/2015","1355","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_TOUCH PRESCRIBING PROGRAM EDUCATIONAL SLIDE SET.pdf" "63","Tysabri","812","05/12/2015","1356","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_TOUCH PRESCRIBING PROGRAM OVERVIEW.pdf" "63","Tysabri","812","05/12/2015","1357","TOUCH Online REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2015-05-12_TOUCH ONLINE REMS WEBSITE .pdf" "22","Gilenya","813","05/14/2015","1358","Dear Healthcare Provider Letter (DHCPL)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_DEAR HEALTHCARE PROFESSIONAL LETTER (DHCPL) .pdf" "22","Gilenya","813","05/14/2015","1359","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_DEAR PROFESSIONAL SOCIETY LETTER .pdf" "22","Gilenya","813","05/14/2015","1360","Guide to Important Safety Information: Using GILENYA in Patients with Relapsing Forms of Multiple Sclerosis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_GUIDE TO IMPORTANT SAFETY INFORMATION - USING GILENYA IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS .pdf" "22","Gilenya","813","05/14/2015","1361","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_REMS WEBSITE.pdf" "22","Gilenya","813","05/14/2015","1362","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_Full.pdf" "22","Gilenya","813","05/14/2015","1363","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gilenya_2015-05-14_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1364","Patient Counseling Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-07-09_PATIENT COUNSELING DOCUMENT (PCD) .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1365","FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-07-09_FDA BLUEPRINT FOR PRESCRIBER EDUCATION .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1366","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opioids_2012-07-09_PRESCRIBER LETTER 1.pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1367","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opioids_2012-07-09_PRESCRIBER LETTER 2 .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1368","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opiods_2012-07-09_PRESCRIBER LETTER 3 .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1369","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opioids_2012-07-09_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1370","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opioids_2012-07-09_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2 .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1371","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_Opioids_2012-07-09_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1372","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-07-09_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","169","07/09/2012","1373","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-07-09_Full.pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1374","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PATIENT COUNSELING DOCUMENT (PCD) .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1375","FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_FDA BLUEPRINT FOR PRESCRIBER EDUCATION .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1376","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PRESCRIBER LETTER 1 .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1377","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PRESCRIBER LETTER 2.pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1378","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PRESCRIBER LETTER 3 .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1379","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1380","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2 .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1381","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1382","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","717","10/25/2013","1383","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2013-10-25_Full.pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1384","Patient Counseling Document (PCD) on Extended Release/Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PATIENT COUNSELING DOCUMENT (PCD) .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1385","FDA Blueprint for Prescriber Education for Extended Release and long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_FDA BLUEPRINT FOR PRESCRIBER EDUCATION .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1386","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PRESCRIBER LETTER 1 .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1387","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PRESCRIBER LETTER 2 .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1388","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PRESCRIBER LETTER 3 .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1389","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1390","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2 .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1391","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1392","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","170","08/28/2012","1393","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2012-08-28_Full .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1394","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PATIENT COUNSELING DOCUMENT (PCD) .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1395","FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_FDA BLUEPRINT FOR PRESCRIBER EDUCATION .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1396","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PRESCRIBER LETTER 1 .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1397","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PRESCRIBER LETTER 2 .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1398","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PRESCRIBER LETTER 3 .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1399","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1400","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2.pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1401","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1402","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","756","06/30/2014","1403","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-06-30_Full .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1404","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PATIENT COUNSELING DOCUMENT (PCD) .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1405","FDA Blueprint for Prescriber Education for Extended Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_FDA BLUEPRINT FOR PRESCRIBER EDUCATION .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1406","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PRESCRIBER LETTER 1 .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1407","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PRESCRIBER LETTER 2 .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1408","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PRESCRIBER LETTER 3 .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1409","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 1 .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1410","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_PROFESSIONAL ORGANIZATION LICENSING BOARD LETTER 2 .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1411","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_REMS WEBSITE .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1412","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_REMS DOCUMENT .pdf" "17","Opioid Analgesic REMS","763","07/23/2014","1413","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA Opioids_2014-07-23_Full.pdf" "43","Prolia","814","05/21/2015","1415","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_LETTER_FOR_HEALTHCARE_PROVIDERS.pdf" "43","Prolia","814","05/21/2015","1416","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_LETTER_FOR_PROFESSIONAL_SOCIETIES.pdf" "43","Prolia","814","05/21/2015","1417","Patient Counseling Chart for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_PATIENT_COUNSELING_CHART_FOR_HEALTHCARE_PROVIDERS.pdf" "43","Prolia","814","05/21/2015","1418","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_PATIENT_BROCHURE.pdf" "43","Prolia","814","05/21/2015","1419","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_JOURNAL_INFORMATION_PIECE.pdf" "43","Prolia","814","05/21/2015","1420","REMs Website (landing page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_REMS_WEBSITE_(LANDING_PAGE).pdf" "43","Prolia","814","05/21/2015","1421","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_REMS_DOCUMENT.pdf" "43","Prolia","814","05/21/2015","1422","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2015-05-21_Full.pdf" "14","Eliquis","764","08/12/2014","1423","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2014-08-12_Full.pdf" "14","Eliquis","764","08/12/2014","1424","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Eliquis_2014-08-12_REMS_DOCUMENT.pdf" "19","Forteo","711","08/30/2013","1427","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Forteo_2013-08-30_Full.pdf" "19","Forteo","711","08/30/2013","1428","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Forteo_2013-08-30_REMS DOCUMENT.pdf" "186","Iclusig","327","12/20/2013","1429","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_Full.pdf" "186","Iclusig","327","12/20/2013","1430","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2013-12-20_REMS DOCUMENT.pdf" "26","Krystexxa","188","10/10/2013","1431","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2013-10-10_Full.pdf" "26","Krystexxa","188","10/10/2013","1432","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2013-10-10_REMS DOCUMENT.pdf" "36","Multaq","725","03/19/2014","1433","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_Full.pdf" "36","Multaq","725","03/19/2014","1434","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Multaq_2014-03-19_REMS DOCUMENT.pdf" "38","Nplate","93","12/06/2011","1435","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _REMS DOCUMENT.pdf" "38","Nplate","93","12/06/2011","1436","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06_Full.pdf" "39","Nulojix","94","06/15/2011","1437","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nulojix_2011-06-15_Full.pdf" "40","Omontys","95","03/27/2012","1438","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Omontys_2012-03-27_Full.pdf" "40","Omontys","95","03/27/2012","1439","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Omontys_2012-03-27_REMS DOCUMENT.pdf" "42","Potiga","98","03/19/2012","1441","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Potiga_2012-03-19_REMS_Document.pdf" "42","Potiga","98","03/19/2012","1442","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Potiga_2012-03-19_REMS_full.pdf" "320","Symlin","753","06/27/2014","1444","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_REMS DOCUMENT.pdf" "320","Symlin","753","06/27/2014","1446","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2014-06-27_Full.pdf" "316","Tanzeum","734","04/15/2014","1447","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_REMS DOCUMENT.pdf" "316","Tanzeum","734","04/15/2014","1448","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2014-04-15_Full.pdf" "66","Victoza","760","07/31/2014","1450","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full_REMS DOCUMENT.pdf" "66","Victoza","760","07/31/2014","1451","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2014-07-31_Full.pdf" "72","Yervoy","162","02/16/2012","1452","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_Full.pdf" "72","Yervoy","162","02/16/2012","1453","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yervoy_2012-02-16_REMS DOCUMENT.pdf" "321","Zydelig","758","07/23/2014","1454","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_Full.pdf" "321","Zydelig","758","07/23/2014","1455","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2014-07-23_REMS DOCUMENT.pdf" "69","Xeljanz","792","02/11/2015","1456","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Dear_Healthcare_Professional_Letter.pdf" "69","Xeljanz","792","02/11/2015","1457","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Dear_Pharmacist_Letter.pdf" "69","Xeljanz","792","02/11/2015","1458","Journal Information Piece For Emergency Medicine Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Journal_Information_Piece_For_Emergency_Medicine_Specialists.pdf" "69","Xeljanz","792","02/11/2015","1459","Journal Information Piece For Family Practitioners General Practitioners and Internal Medicine Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Journal_Information_Piece_For_Family_Practitioners_General_Practitioners_and_Internal_Medicine_Specialists.pdf" "69","Xeljanz","792","02/11/2015","1460","Journal Information Piece For Infectious Disease Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Journal_Information_Piece_For_Infectious_Disease_Specialists.pdf" "69","Xeljanz","792","02/11/2015","1461","Journal Information Piece For Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Journal_Information_Piece_For_Pharmacists.pdf" "69","Xeljanz","792","02/11/2015","1462","Journal Information Piece For Rheumatologists or Rheumatology Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Journal_Information_Piece_For_Rheumatologists_or_Rheumatology_Healthcare_Providers.pdf" "69","Xeljanz","792","02/11/2015","1463","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_REMS_document.pdf" "69","Xeljanz","792","02/11/2015","1464","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_REM_full..pdf" "69","Xeljanz","792","02/11/2015","1465","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.02.11_Screenshot_of_the_Proposed_REMS_Website.pdf" "73","Zyban","729","03/27/2014","1466","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyban_2014.03.27_REMS_document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1467","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_DEAR_PRESCRIBER_LETTER.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1468","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_DEAR_PHARMACIST_LETTER.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1469","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_APPROPRIATE_USE_CHECKLIST.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1470","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_OFFICE_BASED_BUPRENORPHINE_THERAPY_FOR_OPIOID_DEPENDENCE_IMPORTANT_INFORMATION_FOR_PRESCRIBERS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1471","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_OFFICE_BASED_BUPRENORPHINE_THERAPY_FOR_OPIOID_DEPENDENCE_IMPORTANT_INFORMATION_FOR_PHARMACISTS.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1472","BTOD REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_REMS_WEBSITE_SCREENSHOT.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1473","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_REMS_DOCUMENT.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","1474","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-06-04_FULL.pdf" "50","Stelara","196","09/20/2013","1475","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_Full.pdf" "50","Stelara","196","09/20/2013","1476","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Stelara_2013-09-20_REMS DOCUMENT.pdf" "71","Xiaflex","816","10/20/2014","1477","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_DEAR_HEALTHCARE_PROVIDER_LETTER.pdf" "71","Xiaflex","816","10/20/2014","1478","Training Guide for the Administration of Xiaflex for Dupuytren's Contracture","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_TRAINING_GUIDE_FOR_THE_ADMINISTRATION_OF_XIAFLEX_FOR_DUPUYTRENS_CONTRACTURE.pdf" "71","Xiaflex","816","10/20/2014","1479","Training Video for Dupuytren's Contracture","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_PROCEDURE_TRAINING_VIDEO_FOR_DUPUYTRENS_CONTRACTURE.pdf" "71","Xiaflex","816","10/20/2014","1480","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_REMS_WEBSITE_SCREENSHOT.pdf" "71","Xiaflex","816","10/20/2014","1481","Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_TRAINING_GUIDE_FOR_ADMINISTERING_XIAFLEX_FOR_PEYRONIES_DISEASE.pdf" "71","Xiaflex","816","10/20/2014","1482","Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_TRAINING_VIDEO_FOR_ADMINISTERING_XIAFLEX_FOR_PEYRONIES_DISEASE.pdf" "71","Xiaflex","816","10/20/2014","1483","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_HEALTHCARE_PROVIDER_ENROLLMENT_FORM_FOR_PEYRONIES_DISEASE.pdf" "71","Xiaflex","816","10/20/2014","1484","Patient Counseling Tool, "What You Need to Know about Xiaflex Treatment for Peyronie's Disease: A Patient Guide"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_WHAT_YOU_NEED_TO_KNOW_ABOUT_XIAFLEX_TREATMENT_FOR_PEYRONIES_DISEASE_A_PATIENT_GUIDE.pdf" "71","Xiaflex","816","10/20/2014","1485","Pharmacy/Healthcare Setting Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_PHARMACY_HEALTHCARE_SETTING_ENROLLMENT_FORM_FOR_PEYRONIES_DISEASE.pdf" "71","Xiaflex","816","10/20/2014","1486","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_Full.pdf" "71","Xiaflex","816","10/20/2014","1487","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2014-10-20_REMS_DOCUMENT.pdf" "69","Xeljanz","817","06/19/2015","1488","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_REMS_full.pdf" "69","Xeljanz","817","06/19/2015","1489","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_REMS_document.pdf" "69","Xeljanz","817","06/19/2015","1490","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Dear_HealthCare_Provider_Letter.pdf" "69","Xeljanz","817","06/19/2015","1491","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Dear_Pharmacist_Letter.pdf" "69","Xeljanz","817","06/19/2015","1492","Journal Information Piece for Emergency Medicine Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Journal_Information_Piece_for_Emergency_Medicine_Specialists.pdf" "69","Xeljanz","817","06/19/2015","1493","Journal Information Piece for Family Practitioners, General Practitioners, and Internal Medicine Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Journal_Information_Piece_for_Family_Practitioners_General_Practitioners_and_Internal_Medicine_Specialists.pdf" "69","Xeljanz","817","06/19/2015","1494","Journal Information Piece for Infectious Disease Specialists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Journal_Information_Piece_for_Infectious_Disease_Specialists.pdf" "69","Xeljanz","817","06/19/2015","1495","Journal Information Piece for Rheumatologists or Rheumatology Healthcare Providers (including physician assistants and nurse practitioners)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Journal_Information_Piece_for_Rheumatologists_or_Rheumatology_HealthcareProviders.pdf" "69","Xeljanz","817","06/19/2015","1496","Screenshot of the Proposed REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Screenshot_of_the_Proposed_REMS_Website.pdf" "69","Xeljanz","817","06/19/2015","1497","Journal Information Piece for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeljanz_2015.06.19_Journal_Information_Piece_for_Pharmacists.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1498","Screenshot ER/LA Opioid Analgesics REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_ERLA_Opioid_Analgesic_REMS_website.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1499","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1500","Patient Counseling Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Patient_Counseling_Document_on_Extended-Release_Long-Acting_Opioid_Analgesics.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1501","Prescriber Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1502","Prescriber Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1503","Prescriber Letter #3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1504","Professional Organization/Licensing Board Letter #1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Professional_Organization_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1505","Professional Organization/Licensing Board Letter #2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_Professional_Organization_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1506","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015.06.26_REMS_document.pdf" "17","Opioid Analgesic REMS","818","06/26/2015","1507","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_REMS_full.pdf" "57","testosterone (NDA 202763)","819","07/01/2015","1508","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_(NDA_202763)_07-01-2015_REMS_document.pdf" "66","Victoza","820","07/01/2015","1509","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_document.pdf" "66","Victoza","820","07/01/2015","1510","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_Factsheet.pdf" "66","Victoza","820","07/01/2015","1511","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_full.pdf" "66","Victoza","820","07/01/2015","1512","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_Letter_for_Healthcare_Providers.pdf" "66","Victoza","820","07/01/2015","1513","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_Letter_for_Professional_Societies.pdf" "66","Victoza","820","07/01/2015","1514","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_REMS_Slides.pdf" "66","Victoza","820","07/01/2015","1515","Screenshot Victoza REMS website (landing page)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2015.07.01_screenshot_Victoza_REMS_Website_(landing page).pdf" "59","Tikosyn","822","07/08/2015","1516","Dear Healthcare Provider (HCP) Letter for Re-Certification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_HCP_LETTER_FOR_RE-CERTIFICATION.pdf" "59","Tikosyn","822","07/08/2015","1517","Dear Healthcare Provider (HCP) Letter for New Enrollees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_HCP_LETTER_FOR_NEW_ENROLLEES.pdf" "59","Tikosyn","822","07/08/2015","1518","Prescriber Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_PRESCRIBER_CERTIFICATION_FORM.pdf" "59","Tikosyn","822","07/08/2015","1519","Dear Pharmacist Letter for Re-Certification (Institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_PHARMACIST_LETTER_FOR_RE-CERTIFICATION_IN_INSTITUTION.pdf" "59","Tikosyn","822","07/08/2015","1520","Dear Pharmacist Letter for Re-Certification (Retail or Mail Order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_PHARMACIST_LETTER_FOR_RE-CERTIFICATION_IN_RETAIL_OR_MAIL_ORDER_PHARMACIES.pdf" "59","Tikosyn","822","07/08/2015","1521","Dear Pharmacist Letter for New Enrollees (Institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_PHARMACIST_LETTER_FOR_NEW_ENROLLEES_IN_INSTITUTION.pdf" "59","Tikosyn","822","07/08/2015","1522","Dear Pharmacist Letter for New Enrollees (Retail or Mail Order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_DEAR_PHARMACIST_LETTER_FOR_NEW_ENROLLEES_IN_RETAIL_OR_MAIL_ORDER_PHARMACIES.pdf" "59","Tikosyn","822","07/08/2015","1523","Tikosyn Program Treatment Guidelines","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_TIKOSYN_PROGRAM_TREATMENT_GUIDELINES.pdf" "59","Tikosyn","822","07/08/2015","1524","Pharmacy Certification Form (Institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_PHARMACY_CERTIFICATION_FORM_FOR_INSTITUTIONS.pdf" "59","Tikosyn","822","07/08/2015","1525","Pharmacy Certification Form (Retail or Mail Order Pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_PHARMACY_CERTIFICATION_FORM_FOR_RETAIL_OR_MAIL_ORDER_PHARMACIES.pdf" "59","Tikosyn","822","07/08/2015","1526","T.I.P.S. Program Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_TIPS_PROGRAM_BROCHURE.pdf" "59","Tikosyn","822","07/08/2015","1527","Tikosyn REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_TIKOSYN_REMS_WEBSITE_SCREENSHOTS.pdf" "59","Tikosyn","822","07/08/2015","1528","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn _2015-07-08_REMS_DOCUMENT.pdf" "59","Tikosyn","822","07/08/2015","1529","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-07-08_Full.pdf" "345","Xywav and Xyrem","823","07/15/2015","1530","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_REMS_document.pdf" "345","Xywav and Xyrem","823","07/15/2015","1531","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","823","07/15/2015","1532","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","823","07/15/2015","1533","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","823","07/15/2015","1534","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescription_Form.pdf" "345","Xywav and Xyrem","823","07/15/2015","1535","Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","823","07/15/2015","1536","Website (www.xyremrems.com) screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_website_(www.XYREMREMS.com).pdf" "345","Xywav and Xyrem","823","07/15/2015","1537","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","823","07/15/2015","1538","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","823","07/15/2015","1539","Risk Management Report Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_RISK MANAGEMENT REPORT FORM .pdf" "29","Lotronex","824","07/24/2015","1540","Educational Mailing: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_Educational_Mailing_Important_Information_for_Pharmacists.pdf" "29","Lotronex","824","07/24/2015","1541","Website for Patients Section Webshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_LOTRONEXPPL_Website_for_Patients_Sections.pdf" "29","Lotronex","824","07/24/2015","1542","Website For Pharmacists Section Webshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_LOTRONEXPPL_Website_For_Pharmacists_Section_webshots.pdf" "29","Lotronex","824","07/24/2015","1543","Patient Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_Patient_Acknowledgement_Form.pdf" "29","Lotronex","824","07/24/2015","1544","Patient Follow-Up Survey Pre-Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_Patient_Follow-Up_Survey_Pre-Enrollment_Form.pdf" "29","Lotronex","824","07/24/2015","1545","Enrollment Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Enrollment_Letter.pdf" "29","Lotronex","824","07/24/2015","1546","Kit (front cover only)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Kit_(front_cover).pdf" "29","Lotronex","824","07/24/2015","1547","Kit Overview Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Kit_Overview_Letter.pdf" "29","Lotronex","824","07/24/2015","1548","Pharmacist Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Pharmacist_Education_Slide_Deck.pdf" "29","Lotronex","824","07/24/2015","1549","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Prescriber_Education_Slide_Deck.pdf" "29","Lotronex","824","07/24/2015","1550","Sticker Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Sticker_Sheet.pdf" "29","Lotronex","824","07/24/2015","1551","Stickers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_Stickers.pdf" "29","Lotronex","824","07/24/2015","1552","Website For Prescriber Section Webshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_PPL_website_for_prescriber_section_webshots.pdf" "29","Lotronex","824","07/24/2015","1553","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_Prescriber_Enrollment_Form.pdf" "29","Lotronex","824","07/24/2015","1554","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_REMS_document.pdf" "29","Lotronex","824","07/24/2015","1555","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_REMS_full.pdf" "29","Lotronex","824","07/24/2015","1556","Retail Pack - Patient Follow-Up Survey Pre-Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2015.07.24_Retail_Pack-Patient_Follow-Up_Survey_Pre-Enrollment_Form.pdf" "316","Tanzeum","825","07/27/2015","1557","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_document.pdf" "316","Tanzeum","825","07/27/2015","1558","REMS factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_factsheet.pdf" "316","Tanzeum","825","07/27/2015","1559","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_full.pdf" "316","Tanzeum","825","07/27/2015","1560","Letter for Healthcare Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_Letter_for_Healthcare_Providers.pdf" "316","Tanzeum","825","07/27/2015","1561","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_website_screenshot.pdf" "322","Trulicity","826","07/27/2015","1562","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_TRULICITY_REMS_Website_screenshot.pdf" "322","Trulicity","826","07/27/2015","1563","Letter for Professional Societies (print)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_Letter_for_Professional_Societies_print.pdf" "322","Trulicity","826","07/27/2015","1564","Letter for Professional Societies (email)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_Letter_for_Professional_Societies_email.pdf" "322","Trulicity","826","07/27/2015","1565","Letter for Healthcare Providers (print)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_Letter_for_Healthcare_Providers_print.pdf" "322","Trulicity","826","07/27/2015","1566","Letter for Healthcare Providers (email)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_Letter_for_Healthcare_Providers_email.pdf" "322","Trulicity","826","07/27/2015","1567","Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_Factsheet.pdf" "322","Trulicity","826","07/27/2015","1568","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015-07-27_REMS_document.pdf" "322","Trulicity","826","07/27/2015","1569","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2015.07.28_REMS_full.pdf" "27","Kynamro","827","07/28/2015","1570","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2015.07.28_REMS_full.pdf" "27","Kynamro","827","07/28/2015","1571","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescriber_Enrollment_Form.pdf" "27","Kynamro","827","07/28/2015","1572","Prescriber Training slide set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescriber_Training_slide_set.pdf" "27","Kynamro","827","07/28/2015","1573","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescription_Authorization_Form.pdf" "27","Kynamro","827","07/28/2015","1574","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_REMS_document.pdf" "27","Kynamro","827","07/28/2015","1575","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_REMS_website_screenshot.pdf" "27","Kynamro","827","07/28/2015","1576","Summary of Monitoring Recommendations","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Summary_of_Monitoring_Recommendations.pdf" "26","Krystexxa","828","07/30/2015","1577","Dear Healthcare Provider/ Dear Infusion Site Medical Personnel Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2015.07.30_Dear_Healthcare_Provider_Dear_Infusion_Site_Medical_Personnel_Letter.pdf" "26","Krystexxa","828","07/30/2015","1578","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2015.07.30_Journal_Information_Piece.pdf" "26","Krystexxa","828","07/30/2015","1579","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2015.07.30_REMS_document.pdf" "26","Krystexxa","828","07/30/2015","1580","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2015.07.30_REMS_full.pdf" "26","Krystexxa","828","07/30/2015","1581","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Krystexxa_2015.07.30_REMS_website_screenshot.pdf" "345","Xywav and Xyrem","823","07/15/2015","1582","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_REMS_full.pdf" "348","testosterone 1.62% (ANDA 204268)","829","08/04/2015","1583","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_1.62_gel_2015.08.04_REMS_document.pdf" "349","testosterone (ANDA 204571)","830","08/05/2015","1584","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_(ANDA_204571)_2015.08.05_REMS_document.pdf" "320","Symlin","831","08/07/2015","1585","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015.08_REMS_full.pdf" "320","Symlin","831","08/07/2015","1586","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_document.pdf" "320","Symlin","831","08/07/2015","1587","REMS factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_Factsheet.pdf" "320","Symlin","831","08/07/2015","1588","REMS Letter for Health Care Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_Letter_for_Health_Care_Providers_(email_version).pdf" "320","Symlin","831","08/07/2015","1589","REMS Letter for Health Care Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_Letter_for_Health_Care_Providers_(print_version).pdf" "320","Symlin","831","08/07/2015","1590","REMS Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_Letter_for_Professional_Societies_(email_version).pdf" "320","Symlin","831","08/07/2015","1591","REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_Letter_for_Professional_Societies_(print_version).pdf" "320","Symlin","831","08/07/2015","1592","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015_08_07_REMS_website_screenshot.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1593","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015.08.10_REMS_full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1594","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1595","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1596","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1597","Pharmacist Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_Pharmacist_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1598","Prescriber Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_Prescriber_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1599","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_REMS_document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","1600","BTOD REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2015-08-10_screenshot_BTOD_REMS_website.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1601","ER/LA Opioid Analgesic REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_ERLA_opioid_analgesic_REMS_website_screenshot.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1602","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1603","Patient Counseling Document (PCD) on Extended-Release/Long- Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Patient_Counseling_Document.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1604","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Prescriber_Letter1.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1605","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Prescriber_Letter2.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1606","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Prescriber_Letter3.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1607","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Professional_Organization_Licensing_Board_Letter1.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1608","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_Professional_Organization_Licensing_Board_Letter2.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1609","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-08-13_REMS_document.pdf" "17","Opioid Analgesic REMS","833","08/13/2015","1610","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-08-13_REMS_full.pdf" "350","Addyi","834","08/18/2015","1611","Individual Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Individual_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","834","08/18/2015","1612","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Inpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","834","08/18/2015","1613","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Knowledge_Assessment.pdf" "350","Addyi","834","08/18/2015","1614","Multiple Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Multiple_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","834","08/18/2015","1615","Patient-Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Patient-Provider_Agreement_Form.pdf" "350","Addyi","834","08/18/2015","1616","Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Prescriber_and_Pharmacy_Training.pdf" "350","Addyi","834","08/18/2015","1617","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Prescriber_Enrollment_Form.pdf" "350","Addyi","834","08/18/2015","1618","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_REMS_document.pdf" "350","Addyi","834","08/18/2015","1619","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_REMS_full.pdf" "350","Addyi","834","08/18/2015","1620","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2015-08-18_Website_screenshots.pdf" "3","Ampyra","22","01/22/2010","1621","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ampyra_2010-01-22_REMS_Document.pdf" "8","Brilinta","37","07/20/2011","1622","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brilinta_2011-07-20_REMS_Document.pdf" "30","Lumizyme","76","05/24/2010","1623","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumizyme_2010-05-24_REMS_Document.pdf" "32","Metoclopramide (ANDA 71402)","82","09/16/2009","1624","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Metoclopramide_Oral_Solution_(ANDA71)_2009-09-16_REMS_Document.pdf" "44","Promacta","102","11/20/2008","1625","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Promacta_2008-11-20_REMS_Document.pdf" "44","Promacta","103","03/05/2010","1626","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Promacta_2010-03-05_REMS_Document.pdf" "44","Promacta","104","02/25/2011","1627","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Promacta_2011-02-25_REMS_Document.pdf" "44","Promacta","105","12/06/2011","1628","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Promacta_2011-12-06_REMS_Document.pdf" "55","Tasigna","127","06/17/2010","1629","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tasigna_2010-06-17_REMS_Document.pdf" "55","Tasigna","128","01/14/2011","1630","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tasigna_2011-01-14_REMS_Document.pdf" "55","Tasigna","130","11/18/2011","1631","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tasigna_2011-11-18_REMS_Document.pdf" "68","Xarelto","152","11/04/2011","1632","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xarelto_2011-11-04_REMS_Document.pdf" "176","Dilantin oral suspension","241","01/17/2011","1633","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dilantin_oral_suspension_2011-01-17_REMS_Document.pdf" "177","Duetact","243","09/09/2009","1634","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Duetact_2009-09-09_REMS_Document.pdf" "178","Dulera","245","06/22/2010","1635","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dulera_2010-06-22_REMS_Document.pdf" "179","Dysport","248","04/29/2009","1636","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dysport_2009-04-29_REMS_Document.pdf" "151","Actonel","250","01/25/2011","1637","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actonel_2011-01-25_REMS_Document.pdf" "152","Actonel with calcium","251","01/25/2011","1638","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actonel_with_calcium_2011-01-25_REMS_Document.pdf" "156","Actos","252","09/09/2009","1639","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actos_2009-09-09_REMS_Document.pdf" "153","Actoplus Met","254","09/14/2009","1640","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus_Met_2009-09-14_REMS_Document.pdf" "153","Actoplus Met","255","08/04/2011","1641","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus _Met_2011-08-04_REMS_Document.pdf" "155","Actoplus Met XR","257","08/04/2011","1642","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus_Met_XR_2011-08-04_REMS_Document.pdf" "158","Advair HFA","261","06/27/2011","1643","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Advair_HFA_2011-06-27_REMS_Document.pdf" "180","Serevent Diskus","262","11/18/2010","1644","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Serevant_Diskus_2010-11-18_REMS_Document.pdf" "180","Serevent Diskus","263","06/27/2011","1645","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Serevent_Diskus_2011-06-27_REMS_Document.pdf" "160","Arcapta Neohaler","266","07/01/2011","1646","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Arcapta_2011-07-01_REMS_Document.pdf" "162","Avelox","268","04/27/2009","1647","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Avelox_2009-04-27_REMS_Document.pdf" "165","Boniva","273","01/25/2011","1648","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Boniva_2011-01-25_REMS Document.pdf" "165","Boniva","273","01/25/2011","1649","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Boniva_2011-01-25_REMS_Document.pdf" "166","Botox/Botox Cosmetic","274","07/31/2009","1650","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Botox_2009-07-31_REMS_Document.pdf" "167","Brovana","277","02/16/2011","1651","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brovana_2011-02-16_REMS_Document.pdf" "168","Byetta","278","10/30/2009","1652","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Byetta_2009-10-30_REMS_Document.pdf" "169","Cambia","279","06/17/2009","1653","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Cambia_2009-06-17_REMS_Document.pdf" "170","Carbatrol","280","01/26/2011","1654","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carbatrol_2011-01-26_REMS_Document.pdf" "171","Celontin","281","10/11/2010","1655","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Celontin_2010-10-11_REMS_Document.pdf" "181","Cipro","286","04/27/2009","1656","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Cipro_2009-04-27_REMS_Document.pdf" "173","Colcrys (NDA 022351)","288","07/30/2009","1657","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Colcrys_2009-07-30_REMS_Document.pdf" "183","Colcrys (NDA 022353)","292","10/16/2009","1658","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Colcrys_2009-10-16_REMS_Document.pdf" "175","Creon","296","04/30/2009","1659","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Creon_2009-04-30_REMS_Document.pdf" "153","Actoplus Met","298","10/21/2009","1660","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus_Met_2009-10-21_REMS_Document.pdf" "33","Metoclopramide (ANDA 074703)","328","09/15/2009","1661","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Metoclopramide_Oral_Solution_(ANDA74)_2009-09-15_REMS_Document.pdf" "34","Metoclopramide (ANDA 072744)","329","09/15/2009","1662","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Metoclopramide_Oral_Solution_(ANDA72)_2009-09-15_REMS_Document.pdf" "155","Actoplus Met XR","335","12/22/2010","1663","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus_Met_XR_2010-12-22_REMS_Document.pdf" "156","Actos","337","08/04/2011","1664","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actos_2011-08-04_REMS_Document.pdf" "156","Actos","338","02/03/2011","1665","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actos_2011-02-03_REMS_Document.pdf" "158","Advair HFA","340","01/04/2011","1666","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Advair_HFA_2011-01-04_REMS_Document.pdf" "158","Advair HFA","342","09/15/2009","1667","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Advair_HFA_2009-09-15_REMS_Document.pdf" "157","Advair Diskus","344","01/04/2011","1668","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Advair_Diskus_2011-01-04_REMS_Document.pdf" "3","Ampyra","347","11/17/2011","1669","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ampyra_2011-11-17_REMS_Document.pdf" "163","Banzel","351","11/14/2008","1670","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Banzel_2008-11-14_REMS_Document.pdf" "163","Banzel","352","11/08/2010","1671","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Banzel_2010-11-08_REMS_Document.pdf" "163","Banzel","353","03/03/2011","1672","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Banzel_2011-03-03_REMS_Document.pdf" "166","Botox/Botox Cosmetic","359","10/15/2010","1673","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Botox_2010-10-15_REMS_Document.pdf" "166","Botox/Botox Cosmetic","361","08/24/2011","1674","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Botox_2011-08-24_REMS_Document.pdf" "182","Colcrys (NDA 022352)","366","07/29/2009","1675","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Colcrys_2009-07-29_REMS_Document.pdf" "182","Colcrys (NDA 022352)","367","04/29/2010","1676","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Colcrys_2010-04-29_REMS_Document.pdf" "174","Copegus","368","10/08/2010","1677","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copegus_2010-10-08_REMS_Document.pdf" "175","Creon","370","08/12/2010","1678","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Creon_2010-08-12_REMS_Document.pdf" "177","Duetact","371","08/04/2011","1679","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Duetact_2011-08-04_REMS_Document.pdf" "178","Dulera","372","08/18/2011","1680","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dulera_2011-08-18_REMS_Document.pdf" "187","Edluar","374","03/13/2009","1681","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Edluar_2009-03-13_REMS_Document.pdf" "187","Edluar","375","12/17/2010","1682","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Edluar_2010-12-17_REMS_Document.pdf" "188","Effient","377","07/10/2009","1683","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Effient_2009-07-10_REMS_Document.pdf" "188","Effient","379","12/06/2010","1684","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Effient_2010-12-06_REMS_Document.pdf" "188","Effient","380","09/26/2011","1685","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Effient_2011-09-26_REMS_Document.pdf" "189","Enbrel","384","06/03/2010","1686","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Enbrel_2010-06-03_REMS_Document.pdf" "190","Epzicom","389","02/02/2011","1687","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Epzicom_2011-02-02_REMS_Document.pdf" "191","Equetro","391","10/24/2010","1688","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Equetro_2010-10-24_REMS_Document.pdf" "192","Extavia","393","08/14/2009","1689","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extavia_2009-08-14_REMS_Document.pdf" "193","Factive","398","04/27/2009","1690","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Factive_2009-04-27_REMS_Document.pdf" "194","Foradil","400","05/18/2011","1691","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Foradil_2011-05-18_REMS_Document.pdf" "195","Fosamax","401","01/25/2011","1692","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fosamax_2011-01-25_REMS_Document.pdf" "196","Fosamax Plus D","403","01/25/2011","1693","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fosamax_Plus_D_2011-01-25_REMS_Document.pdf" "197","Gabitril","406","10/11/2010","1694","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gabitril_2010-10-11_REMS_Document.pdf" "198","Gralise","408","01/28/2011","1695","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gralise_2011-01-28_REMS_Document.pdf" "23","H.P. Acthar Gel","414","10/15/2010","1696","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/H._P._Acthar_Gel_2010-10-15_REMS_Document.pdf" "200","Humira","415","04/08/2010","1697","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Humira_2010-04-08_REMS_Document.pdf" "201","Infergen","420","08/07/2009","1698","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Infergen_2009-08-07_REMS_Document.pdf" "202","Intron A","421","05/02/2008","1699","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Intron_A_2008-05-02_REMS_Document.pdf" "202","Intron A","422","08/07/2009","1700","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Intron_A_2009-08-07_REMS_Document.pdf" "204","Invirase","428","10/06/2010","1701","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Invirase_2010-10-06_REMS_Document.pdf" "205","Janumet","430","02/26/2010","1702","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Janumet_2010-02-26_REMS_Document.pdf" "206","Januvia","432","02/26/2010","1703","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Januvia_2010-02-26_REMS_Document.pdf" "207","Kalbitor","435","12/01/2009","1704","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kalbitor_2009-12-01_REMS_Document.pdf" "207","Kalbitor","436","08/17/2011","1705","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kalbitor_2011-08-17_REMS_Document.pdf" "209","Kaletra","440","04/06/2009","1706","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kaletra_2009-04-06_REMS_Document.pdf" "209","Kaletra","441","02/24/2011","1707","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kaletra_2011-02-24_REMS_Document.pdf" "209","Kaletra","444","06/14/2010","1708","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kaletra_2010-06-14_REMS_Document.pdf" "210","Keppra","454","04/23/2009","1709","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Keppra_2009-04-23_REMS_Document.pdf" "215","Ketek","456","12/08/2010","1710","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ketek_2010-12-08_REMS_Document.pdf" "216","Klonopin","458","09/01/2010","1711","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Klonopin_2010-09-01_REMS_Document.pdf" "217","Lamictal","461","10/24/2010","1713","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lamictal_2010-10-24_REMS_Document.pdf" "219","Lariam","467","08/20/2009","1714","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lariam_2009-08-20_REMS_Document.pdf" "220","Levaquin","469","04/27/2009","1715","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Levaquin_2009-04-27_REMS_Document.pdf" "221","Lyrica","471","04/23/2009","1716","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lyrica_2009-04-23_REMS_Document.pdf" "221","Lyrica","472","01/04/2010","1717","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lyrica_2010-01-04_REMS_Document.pdf" "228","Morphine Sulfate Oral Solution","482","01/25/2010","1718","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Morphine_Sulfate_2010-01-25_REMS_Document.pdf" "230","Mysoline","486","07/21/2010","1719","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mysoline_2010-07-21_REMS_Document.pdf" "232","Neurontin","492","10/11/2010","1720","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Neurontin_2010-10-11_REMS_Document.pdf" "233","Noroxin","494","04/27/2009","1721","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Noroxin_2009-04-27_REMS_Document.pdf" "234","Nuvigil","497","10/21/2010","1722","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nuvigil_2010-10-21_REMS_Document.pdf" "235","Provigil","499","10/21/2010","1723","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Provigil_2010-10-21_REMS_Document.pdf" "236","Oleptro","501","02/02/2010","1724","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Oleptro_2010-02-02_REMS_Document.pdf" "237","Osmoprep","503","10/13/2009","1725","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Osmoprep_2009-10-13_REMS_Document.pdf" "238","Visicol","505","10/13/2009","1726","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Visicol_2009-10-13_REMS_Document.pdf" "239","Oxycodone hydrochloride oral solution","507","10/20/2010","1727","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Oxycodone_Hydrochloride_2010-10-20_REMS_Document.pdf" "240","Pancreaze","509","04/12/2010","1728","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pancreaze_2010-04-12_REMS_Document.pdf" "241","Peganone","511","06/07/2010","1729","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Peganone_2010-06-07_REMS_Document.pdf" "242","Pegasys","513","02/23/2011","1730","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegasys_2011-02-23_REMS_Document.pdf" "242","Pegasys","514","10/31/2008","1731","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegasys_2008-10-31_REMS_Document.pdf" "242","Pegasys","516","08/07/2009","1732","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegasys_2009-08-07_REMS_Document.pdf" "242","Pegasys","517","05/24/2010","1733","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegasys_2010-05-24_REMS_Document.pdf" "243","PegIntron","519","12/11/2008","1734","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegintron_2008-12-11_REMS Document.pdf" "243","PegIntron","520","08/07/2009","1735","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegintron_2009-08-07_REMS_Document.pdf" "243","PegIntron","521","02/01/2011","1736","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegintron_2011-02-01_REMS_Document.pdf" "244","PegIntron Rebetol Combopack","523","06/13/2008","1737","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pegintron_Rebetol_2008-06-13_REMS_Document.pdf" "245","Pennsaid","525","11/04/2009","1738","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pennsaid_2009-11-04_REMS_Document.pdf" "245","Pennsaid","526","03/25/2010","1739","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pennsaid_2010-03-25_REMS_Document.pdf" "246","Plavix","528","02/01/2011","1740","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Plavix_2011-02-01_REMS_Document.pdf" "247","Perforomist","530","02/01/2011","1741","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Perforomist_2011-02-01_REMS_Document.pdf" "248","Pradaxa","532","10/19/2010","1742","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pradaxa_2010-10-19_REMS_Document.pdf" "249","Propylthiouracil","534","04/01/2010","1743","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Propylthiouracil_2010-04-01_REMS_Document.pdf" "251","Qualaquin","537","06/15/2010","1744","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qualaquin_2010-06-15_REMS_Document.pdf" "252","Rapamune","539","11/23/2010","1745","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rapamune_2010-11-23_REMS_Document.pdf" "253","Rebetol","541","11/06/2009","1746","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rebetol_2009-11-06_REMS_Document.pdf" "253","Rebetol","542","10/28/2010","1747","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rebetol_2010-10-28_REMS_Document.pdf" "254","Reclast","544","01/25/2011","1748","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Reclast_2011-01-25_REMS_Document.pdf" "255","Reglan","546","09/04/2009","1749","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Reglan_2009-09-04_REMS_Document.pdf" "257","Remicade","551","02/17/2011","1750","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Remicade_2011-02-17_REMS_Document.pdf" "257","Remicade","552","11/18/2009","1751","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Remicade_2009-11-18_REMS_Document.pdf" "259","Rozerem","556","10/20/2008","1752","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Rozerem_2008-10-20_REMS_Document.pdf" "260","Samsca","558","05/19/2009","1753","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Samsca_2009-05-19_REMS_Document.pdf" "260","Samsca","559","09/23/2011","1754","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Samsca_2011-09-23_REMS_Document.pdf" "261","Savella","561","01/14/2009","1755","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Savella_2009-01-14_REMS_Document.pdf" "261","Savella","562","02/02/2010","1756","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Savella_2010-02-02_REMS_Document.pdf" "263","Seroquel","569","12/02/2009","1757","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Seroquel_XR_2009-12-02_REMS_Document.pdf" "266","Simponi","577","04/24/2009","1758","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Simponi_2009-04-24_REMS_Document.pdf" "266","Simponi","579","07/29/2010","1759","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Simponi_2010-07-29_REMS_Document.pdf" "267","Sucraid","581","11/20/2008","1760","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sucraid_2008-11-20_REMS_Document.pdf" "268","Suprep Bowel Prep Kit","583","08/05/2010","1761","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suprep_2010-08-05_REMS_Document.pdf" "269","Sutent","585","07/01/2010","1762","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sutent_2010-07-01_REMS_Document.pdf" "270","Symbicort","587","02/27/2009","1763","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symbicort_2009-02-27_REMS_Document.pdf" "270","Symbicort","588","08/18/2011","1764","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symbicort_2011-08-18_REMS_Document.pdf" "270","Symbicort","589","02/16/2011","1765","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symbicort_2011-02-16_REMS_Document.pdf" "271","Symbyax","591","03/19/2009","1766","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symbyax_2009-03-19_REMS_Document.pdf" "272","Tegretol","594","03/03/2011","1767","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegretol_2011-03-03_REMS_Document.pdf" "273","Topamax","596","04/23/2009","1768","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Topamax_2009-04-23_REMS_Document.pdf" "273","Topamax","597","03/04/2011","1769","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Topamax_2011-03-04_REMS_Document.pdf" "274","Tranxene","599","06/07/2010","1770","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tranxene_2010-06-07_REMS_Document.pdf" "284","Trileptal","631","03/03/2011","1771","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trileptal_2011-03-03_REMS_Document.pdf" "285","Trilipix","633","12/15/2008","1772","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trilipix_2008-12-15_REMS_Document.pdf" "285","Trilipix","634","09/14/2010","1773","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trilipix_2010-09-14_REMS_Document.pdf" "286","Trizivir","640","08/04/2010","1774","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trizivir_2010-08-04_REMS_ Document.pdf" "287","Ziagen","643","08/04/2010","1775","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ziagen_2010-08-04_REMS_ Document.pdf" "288","Tyzeka","645","01/23/2009","1776","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyzeka_2009-01-23_REMS_Document.pdf" "288","Tyzeka","646","04/28/2009","1777","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyzeka_2009-04-28_REMS_Document.pdf" "288","Tyzeka","647","09/10/2010","1778","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyzeka_2010-09-10_REMS_Document.pdf" "289","Venlafaxine ER","649","05/20/2008","1779","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Venlafaxine_ER_2008-05-20_REMS_Document.pdf" "290","Videx","651","01/25/2010","1780","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Videx_2010-01-25_REMS_Document.pdf" "291","Viibryd","653","01/21/2011","1781","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Viibyrd_2011-01-21_REMS_Document.pdf" "292","Vimpat","656","04/20/2010","1782","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vimpat_2010-04-20_REMS_Document.pdf" "293","Viramune","661","01/07/2011","1783","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Viramune_2011-01-07_REMS_Document.pdf" "293","Viramune","662","07/20/2010","1784","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Viramune_2010-07-20_REMS_Document.pdf" "293","Viramune","663","01/13/2010","1785","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Viramune_2010-01-13_REMS_Document.pdf" "294","Votrient","666","10/19/2009","1786","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Votrient_2009-10-19_REMS_Document.pdf" "295","Wellbutrin","668","02/26/2010","1787","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Wellbutrin_2010-02-26_REMS_Document.pdf" "297","Xeomin","673","07/30/2010","1788","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xeomin_2010-07-30_REMS_Document.pdf" "298","Xolair","675","07/24/2009","1789","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xolair_2009-07-24_REMS_Document.pdf" "298","Xolair","676","12/21/2010","1790","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xolair_2010-12-21_REMS_Document.pdf" "299","Zarontin","678","09/14/2010","1791","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zarontin_2010-09-14_REMS_Document.pdf" "300","Zenpep","680","08/27/2009","1792","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zenpep_2009-08-27_REMS_Document.pdf" "301","Zerit","682","12/10/2010","1793","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zerit_2010-12-10_REMS_Document.pdf" "303","Zolpimist","686","12/19/2008","1794","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zolpimist_2008-12-19_REMS_Document.pdf" "303","Zolpimist","687","10/11/2010","1795","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zolpimist_2010-10-11_REMS_Document.pdf" "304","Zonegran","689","04/23/2009","1796","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zonegran_2009-04-23_REMS_Document.pdf" "304","Zonegran","690","04/19/2010","1797","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zonegran_2010-04-19_REMS_Document.pdf" "305","Zortress","693","11/21/2011","1798","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zortress_2011-11-21_REMS_Document.pdf" "306","Zyprexa","696","12/04/2009","1799","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_2009-12-04-19_REMS_Document.pdf" "201","Infergen","703","07/02/2010","1800","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Infergen_2010-07-02_REMS Document.pdf" "309","Metoclopramide (ANDA 073680)","707","09/11/2009","1801","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Metoclopramide_Oral_Solution_(ANDA73)_2009-09-11_REMS_Document.pdf" "250","Proquin XR","708","04/27/2009","1802","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Proquin_XR_2009-04-27_REMS_Document.pdf" "312","Wellbutrin XL","719","02/26/2010","1803","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Wellbutrin_XL_2010-02-26_REMS_Document.pdf" "314","Myalept","836","08/27/2015","1804","Myalept REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_Myalept_REMS_Program_An_Introduction.pdf" "314","Myalept","836","08/27/2015","1805","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_Prescriber_Enrollment_Form.pdf" "314","Myalept","836","08/27/2015","1806","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_Prescriber_Training_Module.pdf" "314","Myalept","836","08/27/2015","1807","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_Prescription_Authorization_Form.pdf" "314","Myalept","836","08/27/2015","1808","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_REMS_document.pdf" "314","Myalept","836","08/27/2015","1809","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2015.08.27_REMS_full.pdf" "314","Myalept","836","08/27/2015","1810","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_08-27-2015_REMS_program_website.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1811","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Guide_to_Isotretinoin_for_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1812","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Guide_to_Isotretinoin_for_Male_Patients_and_Female_Patients_who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1814","Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Isotretinoin_Educational_Kit_for_Males_and_Females_of_Non-Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1816","Isotretinoin Educational Kit for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Isotretinoin_Educational_Kit_for_Females_of_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1818","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Patient_Monthly_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1819","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Instructions_for_Managing_Office_Staff_Designees.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1820","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Office_Staff_Designee_Registration_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1821","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Patient_Information_Informed_Consent_for_all_patients.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1822","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Patient_Information_Informed_Consent_for_Females_of_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1823","Pharmacist Guide for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1824","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1825","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1826","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1827","Recognizing Psychiatric Disorders In Adolescents And Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Recognizing_Psychiatric_Disorders_In_Adolescents_And_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1828","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_REMS_document.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1829","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Request_for_Exemption_for_Patients_with_Serious_Medical_Reasons.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1830","The Guide to Best Practices For the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_The_Guide_to_Best_Practices_For_the_iPLEDGE_Program.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1831","The iPLEDGE Program Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_The_iPLEDGE_Program_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1832","transcript for DVD: Be Prepared, Be Protected","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_transcript_DVD_Be_Prepared_Be_Protected.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1833","transcript for DVD: Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_transcript_DVD_Be_Aware_Video.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1834","Wholesaler agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_Wholesaler_Agreement.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1835","Wholesaler to wholesaler shipment request form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_09-03-2015_wholesaler_to_wholesaler_shipment_request_form.pdf" "24","Isotretinoin iPLEDGE","837","09/03/2015","1836","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/isotretinoin_2015-09-03_REMS_full.pdf" "58","Thalomid","838","09/13/2015","1837","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_REMS_document.pdf" "58","Thalomid","838","09/13/2015","1838","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Prescriber_Enrollment_Form.pdf" "58","Thalomid","838","09/13/2015","1839","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Patient_Prescription_Form.pdf" "58","Thalomid","838","09/13/2015","1840","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Patient_Prescription_Form_VA.pdf" "58","Thalomid","838","09/13/2015","1841","Prescriber Guide to Thalomid REMS program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Prescriber_Guide.pdf" "58","Thalomid","838","09/13/2015","1842","Thalomid REMS REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_At-A-Glance.pdf" "58","Thalomid","838","09/13/2015","1843","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Welcome_Letter.pdf" "58","Thalomid","838","09/13/2015","1844","Celgene Risk Management.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Celgene_website.pdf" "58","Thalomid","838","09/13/2015","1845","Pharmacy Guide to Thalomid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Pharmacy_Guide.pdf" "58","Thalomid","838","09/13/2015","1846","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Education_Counseling_Checklist.pdf" "58","Thalomid","838","09/13/2015","1847","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","838","09/13/2015","1848","Pharmacy Certification Quiz (the Thalomid REMS program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","838","09/13/2015","1849","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_for_Adult_Male.pdf" "58","Thalomid","838","09/13/2015","1850","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_for_Male_Child.pdf" "58","Thalomid","838","09/13/2015","1851","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","838","09/13/2015","1852","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","838","09/13/2015","1853","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","838","09/13/2015","1854","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","838","09/13/2015","1855","Patient Guide to Thalomid REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Patient_Guide.pdf" "58","Thalomid","838","09/13/2015","1856","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Emergency_Contraception_Brochure.pdf" "58","Thalomid","838","09/13/2015","1857","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","838","09/13/2015","1858","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","838","09/13/2015","1859","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","838","09/13/2015","1860","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-09-13_REMS_full.pdf" "351","Clozapine","840","09/15/2015","1885","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_REMS_document.pdf" "351","Clozapine","840","09/15/2015","1886","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","840","09/15/2015","1887","Knowledge Assessment for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Knowledge_Assessment_for_Healthcare_Providers.pdf" "351","Clozapine","840","09/15/2015","1888","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Prescriber_Enrollment_Form.pdf" "351","Clozapine","840","09/15/2015","1889","Prescriber Designee Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Prescriber_Designee_Enrollment_Form.pdf" "351","Clozapine","840","09/15/2015","1890","What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Guide_for_Patients_and_Caregivers.pdf" "351","Clozapine","840","09/15/2015","1892","REMS Program website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_REMS_Program_website.pdf" "351","Clozapine","840","09/15/2015","1893","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","840","09/15/2015","1894","Chain Headquarters Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Chain_Headquarters_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","840","09/15/2015","1895","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_Patient_Enrollment_Form.pdf" "351","Clozapine","840","09/15/2015","1896","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_REMS_full.pdf" "46","Revlimid","842","09/13/2015","1897","Celgene REMS Programs Pharmacy Training: Revlimid REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Celgene_REMS_Programs_Pharmacy_Training.pdf" "46","Revlimid","842","09/13/2015","1898","Celgene Risk Management.com Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Celgene_website.pdf" "46","Revlimid","842","09/13/2015","1899","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Education_Counseling_Checklist.pdf" "46","Revlimid","842","09/13/2015","1900","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Emergency_Contraception_Brochure.pdf" "46","Revlimid","842","09/13/2015","1901","Patient Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Patient_Guide.pdf" "46","Revlimid","842","09/13/2015","1902","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Patient_Prescription_Form.pdf" "46","Revlimid","842","09/13/2015","1903","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Patient_Prescription_Form_VA.pdf" "46","Revlimid","842","09/13/2015","1904","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","842","09/13/2015","1905","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","842","09/13/2015","1906","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","842","09/13/2015","1907","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_for_Adult_Male.pdf" "46","Revlimid","842","09/13/2015","1908","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","842","09/13/2015","1909","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","842","09/13/2015","1910","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_PPAF_for_Male_Child.pdf" "46","Revlimid","842","09/13/2015","1911","Pharmacy Certification Quiz (the Revlimid REMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","842","09/13/2015","1912","Pharmacy Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Pharmacy_Guide.pdf" "46","Revlimid","842","09/13/2015","1913","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Prescriber_Enrollment_Form.pdf" "46","Revlimid","842","09/13/2015","1914","Prescriber Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Prescriber_Guide .pdf" "46","Revlimid","842","09/13/2015","1915","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_REMS_document.pdf" "46","Revlimid","842","09/13/2015","1916","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_REMS_Full.pdf" "46","Revlimid","842","09/13/2015","1917","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_At-A-Glance.pdf" "46","Revlimid","842","09/13/2015","1918","Revlimid REMS Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","842","09/13/2015","1919","Revlimid Risk Evaluation and Mitgation Strategy (REMS) Program Education and Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","842","09/13/2015","1920","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-09-13_Welcome_Letter.pdf" "41","Pomalyst","843","09/14/2015","1921","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_REMS_full.pdf" "41","Pomalyst","843","09/14/2015","1922","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_REMS_document.pdf" "41","Pomalyst","843","09/14/2015","1923","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","843","09/14/2015","1924","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Patient_Prescription_Form .pdf" "41","Pomalyst","843","09/14/2015","1925","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Patient_Prescription_Form_VA.pdf" "41","Pomalyst","843","09/14/2015","1926","Prescriber Guide to Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Prescriber_Guide.pdf" "41","Pomalyst","843","09/14/2015","1927","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_At-A-Glance.pdf" "41","Pomalyst","843","09/14/2015","1928","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Welcome_Letter.pdf" "41","Pomalyst","843","09/14/2015","1929","Celgene Risk Management Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Celgene_website.pdf" "41","Pomalyst","843","09/14/2015","1930","Pharmacy Guide to Pomalyst REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Pharmacy_Guide .pdf" "41","Pomalyst","843","09/14/2015","1931","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Education_Counseling_Checklist.pdf" "41","Pomalyst","843","09/14/2015","1932","Celgene REMS Programs Pharmacy Training: Pomalyst REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","843","09/14/2015","1933","Pharmacy Certification Quiz (the Pomalyst REMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","843","09/14/2015","1934","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_for_Adult_Male.pdf" "41","Pomalyst","843","09/14/2015","1935","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_for_Male_Child.pdf" "41","Pomalyst","843","09/14/2015","1936","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","843","09/14/2015","1937","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","843","09/14/2015","1938","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","843","09/14/2015","1939","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","843","09/14/2015","1940","Patient Guide to Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Patient_Guide.pdf" "41","Pomalyst","843","09/14/2015","1941","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","843","09/14/2015","1942","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Patient_Survey_Reminder_Card.pdf" "41","Pomalyst","843","09/14/2015","1943","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","843","09/14/2015","1944","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-09-14_Patient_Resource_Pack_Envelope.pdf" "351","Clozapine","840","09/15/2015","1945","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/clozapine_2015-09-15_ANC_Lab_Reporting_Form.pdf" "320","Symlin","844","09/18/2015","1946","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_full.pdf" "320","Symlin","844","09/18/2015","1947","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_document.pdf" "320","Symlin","844","09/18/2015","1948","REMS factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_factsheet.pdf" "320","Symlin","844","09/18/2015","1949","REMS Letter for Health Care Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_Letter_Health_Care_Providers_(email).pdf" "320","Symlin","844","09/18/2015","1950","REMS Letter for Health Care Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_Letter_Health_Care_Providers_(print).pdf" "320","Symlin","844","09/18/2015","1951","REMS Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_Letter_Professional_Societies_(email).pdf" "320","Symlin","844","09/18/2015","1952","REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_Letter_Professional_Societies_(print).pdf" "320","Symlin","844","09/18/2015","1953","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Symlin_2015-9-18_REMS_website_screenshot.pdf" "340","Lemtrada","846","09/18/2015","1954","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_REMS_full.pdf" "340","Lemtrada","846","09/18/2015","1955","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_REMS_document.pdf" "340","Lemtrada","846","09/18/2015","1956","The REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_DHCP_Letter.pdf" "340","Lemtrada","846","09/18/2015","1957","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_REMS_website_screenshot.pdf" "340","Lemtrada","846","09/18/2015","1958","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Program_Overview.pdf" "340","Lemtrada","846","09/18/2015","1959","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Education_Program_Prescribers.pdf" "340","Lemtrada","846","09/18/2015","1960","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Knowledge_Assessment.pdf" "340","Lemtrada","846","09/18/2015","1961","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","846","09/18/2015","1962","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Patient_Enrollment_Form.pdf" "340","Lemtrada","846","09/18/2015","1963","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Patient_Status_Form.pdf" "340","Lemtrada","846","09/18/2015","1964","What You Need to Know About Lemtrada Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_A_Patient_Guide.pdf" "340","Lemtrada","846","09/18/2015","1965","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Prescription_Ordering_Form.pdf" "340","Lemtrada","846","09/18/2015","1966","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Patient_Authorization_Baseline_Lab.pdf" "340","Lemtrada","846","09/18/2015","1967","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Patient_Reminder_Letter.pdf" "340","Lemtrada","846","09/18/2015","1968","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","846","09/18/2015","1969","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","846","09/18/2015","1970","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Education_Program_Healthcare_Facilities.pdf" "340","Lemtrada","846","09/18/2015","1971","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Infusion_Checklist.pdf" "340","Lemtrada","846","09/18/2015","1972","What You Need to Know about LEMTRADA Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Infusion_Reactions_A_Patient_Guide.pdf" "340","Lemtrada","846","09/18/2015","1974","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2015-09-18_Patient_Safety_Information_Card.pdf" "352","Suboxone/Subutex","850","09/22/2015","1975","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2015-09-22_REMS_full.pdf" "352","Suboxone/Subutex","850","09/22/2015","1976","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_REMS_document.pdf" "352","Suboxone/Subutex","850","09/22/2015","1977","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","850","09/22/2015","1978","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","850","09/22/2015","1979","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","850","09/22/2015","1980","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_Prescriber_Brochure.pdf" "352","Suboxone/Subutex","850","09/22/2015","1981","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_Pharmacist_Brochure.pdf" "352","Suboxone/Subutex","850","09/22/2015","1982","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_09-22-2015_REMS_website_screenshot.pdf" "353","testosterone (ANDA 076744)","851","09/25/2015","1983","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_ANDA_076744_2015-09-25_REMS_document.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1984","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_REMS_full.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1985","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_REMS_document.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1986","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_PCD.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1987","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Blueprint.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1988","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1989","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1990","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1991","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Professional_Letter_1.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1992","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_Professional_Letter_2.pdf" "17","Opioid Analgesic REMS","853","10/02/2015","1993","ER/LA Opioid Analgesic REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2015-10-02_website_screenshot.pdf" "28","Letairis","852","10/02/2015","1994","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_REMS_full.pdf" "28","Letairis","852","10/02/2015","1995","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_REMS_document.pdf" "28","Letairis","852","10/02/2015","1996","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Prescriber_Enrollment_and_Agreement_Form.pdf" "28","Letairis","852","10/02/2015","1997","Prescriber Guide to the Letairis REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Prescriber_Guide_to_the_Letairis_REMS_Program.pdf" "28","Letairis","852","10/02/2015","1998","Letairis REMS Program Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Program_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "28","Letairis","852","10/02/2015","1999","Patient Enrollment and Consent Forms","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Patient_Enrollment_and_Consent_Form.pdf" "28","Letairis","852","10/02/2015","2000","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Change_in_Reproductive_Potential_Status.pdf" "28","Letairis","852","10/02/2015","2001","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2015-10-02_Letairis_REMS_website_screenshot.pdf" "18","Extraneal","855","10/16/2015","2002","Patient Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_10_16_2015_Patient_Kit.pdf" "18","Extraneal","855","10/16/2015","2003","Patient Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_10_16_2015_Patient_Training_Tool.pdf" "18","Extraneal","855","10/16/2015","2004","Peritoneal Dialysis Nurse Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_10_16_2015_PD_Nurse_Training_Tool.pdf" "18","Extraneal","855","10/16/2015","2005","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_10_16_2015_REMS_document.pdf" "18","Extraneal","855","10/16/2015","2006","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2015-10-16_REMS_full.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2007","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_REMS_full.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2008","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_REMS_document.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2009","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_PCD.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2010","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2011","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_Prescriber_Letter1.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2012","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_Prescriber_Letter2.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2013","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_Prescriber_Letter3.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2014","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_Professional_Org_Letter1.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2015","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_Professional_Org_Letter2.pdf" "17","Opioid Analgesic REMS","856","10/23/2015","2016","ER/LA Opioid Analgesic REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2015-10-23_REMS_website_screenshot.pdf" "48","Sabril","857","10/22/2015","2017","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_REMS_full.pdf" "48","Sabril","857","10/22/2015","2018","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_REMS_document.pdf" "48","Sabril","857","10/22/2015","2019","Dear Healthcare Professional (HCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_DHCP_letter.pdf" "48","Sabril","857","10/22/2015","2020","Dear HCP Medication Taper Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_DHCP_taper_letter.pdf" "48","Sabril","857","10/22/2015","2021","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_prescriber_enrollment.pdf" "48","Sabril","857","10/22/2015","2022","Treatment Initiation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_treatment_initiation_form.pdf" "48","Sabril","857","10/22/2015","2023","Treatment Maintenance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_treatment_maintenance_form.pdf" "48","Sabril","857","10/22/2015","2024","Ophthalmologic Assessment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_ophthalmologic_assessment_form.pdf" "48","Sabril","857","10/22/2015","2025","Patient/Parent/Legal Guardian-Physician Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2015-10-22_patient_physician_agreement.pdf" "58","Thalomid","858","10/27/2015","2026","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_REMS_document.pdf" "58","Thalomid","858","10/27/2015","2027","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Prescriber_Enrollment_Form.pdf" "58","Thalomid","858","10/27/2015","2028","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Patient_Prescription_Form.pdf" "58","Thalomid","858","10/27/2015","2029","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Patient_Prescription_Form_VA.pdf" "58","Thalomid","858","10/27/2015","2030","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Prescriber_Guide.pdf" "58","Thalomid","858","10/27/2015","2031","Thalomid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_At-A-Glance.pdf" "58","Thalomid","858","10/27/2015","2032","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Welcome_Letter.pdf" "58","Thalomid","858","10/27/2015","2033","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Celgene_website.pdf" "58","Thalomid","858","10/27/2015","2034","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Pharmacy_Guide.pdf" "58","Thalomid","858","10/27/2015","2035","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Education_Counseling_Checklist.pdf" "58","Thalomid","858","10/27/2015","2036","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","858","10/27/2015","2037","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","858","10/27/2015","2038","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_for_Adult_Male.pdf" "58","Thalomid","858","10/27/2015","2039","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_for_Male_Child.pdf" "58","Thalomid","858","10/27/2015","2040","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","858","10/27/2015","2041","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","858","10/27/2015","2042","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","858","10/27/2015","2043","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","858","10/27/2015","2044","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Patient_Guide.pdf" "58","Thalomid","858","10/27/2015","2045","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Emergency_Contraception_Brochure.pdf" "58","Thalomid","858","10/27/2015","2046","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","858","10/27/2015","2047","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","858","10/27/2015","2048","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_Patient_Resource_Pack_Envelope.pdf" "41","Pomalyst","859","10/27/2015","2049","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_REMS_document.pdf" "41","Pomalyst","859","10/27/2015","2050","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","859","10/27/2015","2051","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Patient_Prescription_Form.pdf" "41","Pomalyst","859","10/27/2015","2052","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomlayst_2015-10-27_Patient_Prescription_Form_VA.pdf" "41","Pomalyst","859","10/27/2015","2053","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Prescriber_Guide.pdf" "41","Pomalyst","859","10/27/2015","2054","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_At-A-Glance.pdf" "41","Pomalyst","859","10/27/2015","2055","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Welcome_Letter.pdf" "41","Pomalyst","859","10/27/2015","2056","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Celgene_website.pdf" "41","Pomalyst","859","10/27/2015","2057","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Pharmacy_Guide.pdf" "41","Pomalyst","859","10/27/2015","2058","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Education_Counseling_Checklist.pdf" "41","Pomalyst","859","10/27/2015","2059","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","859","10/27/2015","2060","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","859","10/27/2015","2061","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_for_Adult_Male.pdf" "41","Pomalyst","859","10/27/2015","2062","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_for_Male_Child.pdf" "41","Pomalyst","859","10/27/2015","2063","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","859","10/27/2015","2064","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","859","10/27/2015","2065","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","859","10/27/2015","2066","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","859","10/27/2015","2067","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Patient_Guide.pdf" "41","Pomalyst","859","10/27/2015","2068","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","859","10/27/2015","2069","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Patient_Survey_Reminder_Card.pdf" "41","Pomalyst","859","10/27/2015","2070","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","859","10/27/2015","2071","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","858","10/27/2015","2072","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-10-27_REMS_full.pdf" "41","Pomalyst","859","10/27/2015","2073","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-10-27_REMS_full.pdf" "46","Revlimid","860","10/27/2015","2074","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_REMS_document.pdf" "46","Revlimid","860","10/27/2015","2075","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Prescriber_Enrollment_Form.pdf" "46","Revlimid","860","10/27/2015","2076","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Patient_Prescription_Form.pdf" "46","Revlimid","860","10/27/2015","2077","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Patient_Prescription_Form_VA.pdf" "46","Revlimid","860","10/27/2015","2078","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Prescriber_Guide.pdf" "46","Revlimid","860","10/27/2015","2079","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_At-A-Glance.pdf" "46","Revlimid","860","10/27/2015","2080","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Welcome_Letter.pdf" "46","Revlimid","860","10/27/2015","2081","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Celgene_website.pdf" "46","Revlimid","860","10/27/2015","2082","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Pharmacy_Guide.pdf" "46","Revlimid","860","10/27/2015","2083","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Education_Counseling_Checklist.pdf" "46","Revlimid","860","10/27/2015","2084","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Celgene_REMS_Programs_Pharmacy_Training.pdf" "46","Revlimid","860","10/27/2015","2085","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","860","10/27/2015","2086","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_for_Adult_Male.pdf" "46","Revlimid","860","10/27/2015","2087","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_for_Male_Child.pdf" "46","Revlimid","860","10/27/2015","2088","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","860","10/27/2015","2089","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","860","10/27/2015","2090","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","860","10/27/2015","2091","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","860","10/27/2015","2092","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Patient_Guide.pdf" "46","Revlimid","860","10/27/2015","2093","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Emergency_Contraception_Brochure.pdf" "46","Revlimid","860","10/27/2015","2094","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","860","10/27/2015","2095","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","860","10/27/2015","2096","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","860","10/27/2015","2097","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-10-27_REMS_full.pdf" "355","testosterone 1% (ANDA 076737)","861","11/05/2015","2099","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_(ANDA_076737)_2015-11-05_REMS_document.pdf" "346","Ionsys","862","11/12/2015","2100","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_Dear_Healthcare_Provider_Letter.pdf" "346","Ionsys","862","11/12/2015","2101","Dear Hospital Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_Dear_Hospital_Pharmacy_Letter.pdf" "346","Ionsys","862","11/12/2015","2102","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_Hospital_Enrollment_Form.pdf" "346","Ionsys","862","11/12/2015","2103","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_Knowledge_Assessment.pdf" "346","Ionsys","862","11/12/2015","2104","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_REMS_Document.pdf" "346","Ionsys","862","11/12/2015","2105","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_REMS_Full.pdf" "346","Ionsys","862","11/12/2015","2106","REMS Website Mockups Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_REMS_Website_Mockups_Screenshot.pdf" "346","Ionsys","862","11/12/2015","2107","Safety Brochure Guide for Nurses and Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2015-11-12_Safety_Brochure_Guide_for_Nurses_and_Pharmacists.pdf" "37","Mycophenolate","863","11/13/2015","2108","Brochure for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","863","11/13/2015","2109","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","863","11/13/2015","2110","DHCP Letter for Centers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_DHCP_Letter_for_Centers.pdf" "37","Mycophenolate","863","11/13/2015","2111","DHCP Introductory Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Dear_Healthcare_Provider_Letter.pdf" "37","Mycophenolate","863","11/13/2015","2112","Patient Brochure: What You Need to Know About Mycophenolate","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Patient_Brochure_What_You_Need_To_Know_About_Mycophenolate.pdf" "37","Mycophenolate","863","11/13/2015","2113","Obstetrician/Gynecologist Referral Template Letter for Contraception Counseling","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Obstetrician_Gynecologist_Referral_Template_Letter_for_Contraception_Counseling.pdf" "37","Mycophenolate","863","11/13/2015","2114","Obstetrician/Gynecologist Referral Template Letter for Preconception Counseling","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Obstetrician_Gynecologist_Referall_Template_Letter_for_Preconception_Counseling.pdf" "37","Mycophenolate","863","11/13/2015","2115","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Patient_Prescriber_Acknowledgement_Form.pdf" "37","Mycophenolate","863","11/13/2015","2116","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","863","11/13/2015","2117","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_REMS_Document.pdf" "37","Mycophenolate","863","11/13/2015","2118","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_REMS_Full.pdf" "37","Mycophenolate","863","11/13/2015","2119","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Mycophenolate_REMS_Program_Website_Screenshots.pdf" "76","Opsumit","864","11/17/2015","2120","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_REMS_Full.pdf" "76","Opsumit","864","11/17/2015","2121","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Opsumit_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","864","11/17/2015","2122","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Opsumit_REMS_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "76","Opsumit","864","11/17/2015","2123","Prescriber and Pharmacy Guide for the Opsumit REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Prescriber_and_Pharmacy_Guide_for_the_Opsumit_REMS_Program.pdf" "76","Opsumit","864","11/17/2015","2124","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Opsumit_REMS_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","864","11/17/2015","2125","Opsumit_2020_04_08_Guide_for_Female_Patients.pdf","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Opsumit_REMS_Change_in_Reproductive_Potential_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "76","Opsumit","864","11/17/2015","2126","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_REMS_Website_Screenshots.pdf" "76","Opsumit","864","11/17/2015","2127","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_Opsumit_REMS_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","864","11/17/2015","2128","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2015-11-17_REMS_Document.pdf" "59","Tikosyn","866","11/25/2015","2129","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_REMS_full.pdf" "59","Tikosyn","866","11/25/2015","2130","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_REMS_document.pdf" "59","Tikosyn","866","11/25/2015","2131","Dear Healthcare Provider Letter for re-certification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_DHCP_letter_re-certification.pdf" "59","Tikosyn","866","11/25/2015","2132","Dear Healthcare Provider Letter for new enrollees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_DHCP_letter_new-enrollees.pdf" "59","Tikosyn","866","11/25/2015","2133","Treatment Guidelines","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Treatment_Guidelines.pdf" "59","Tikosyn","866","11/25/2015","2134","Prescriber Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Prescriber_Certification_Form.pdf" "59","Tikosyn","866","11/25/2015","2135","REMS Website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_REMS_Website_screenshots.pdf" "59","Tikosyn","866","11/25/2015","2136","Dear Pharmacist Letter for re-certification (institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Dear_Pharmacist_letter_re-certificaiton_(institution).pdf" "59","Tikosyn","866","11/25/2015","2137","Dear Pharmacist Letter for new enrollees (institution)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Dear_Pharmacist_letter_new_enrollees_(institution).pdf" "59","Tikosyn","866","11/25/2015","2138","Dear Pharmacist Letter for re-certification (retail/mail-order pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Dear_Pharmacist_letter_re-certificaiton_(retail_mail-order).pdf" "59","Tikosyn","866","11/25/2015","2139","Dear Pharmacist Letter for new enrollees (retail/mail-order pharmacies)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Dear_Pharmacist_letter_new_enrollees_(retail_mail-order).pdf" "59","Tikosyn","866","11/25/2015","2140","Pharmacy Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Pharmacy_Certification_Form.pdf" "59","Tikosyn","866","11/25/2015","2141","Institution Certification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_Institution_Certification_Form.pdf" "59","Tikosyn","866","11/25/2015","2142","Tikosyn and its Authorized Generic In Pharmacy Systems (T.I.P.S) Program Brochure describing the steps needed for retail pharmacies to enroll, order and dispense Tikosyn and its authorized generic","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tikosyn_2015-11-25_TIPS_Program_brochure.pdf" "58","Thalomid","869","12/01/2015","2143","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_REMS_document.pdf" "58","Thalomid","869","12/01/2015","2144","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Prescriber_Enrollment_Form.pdf" "58","Thalomid","869","12/01/2015","2145","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Patient_Prescription_Form.pdf" "58","Thalomid","869","12/01/2015","2146","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Patient_Prescription_Form_VA.pdf" "58","Thalomid","869","12/01/2015","2147","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Prescriber_Guide.pdf" "58","Thalomid","869","12/01/2015","2148","Thalomid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_At-A-Glance.pdf" "58","Thalomid","869","12/01/2015","2149","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Welcome_Letter.pdf" "58","Thalomid","869","12/01/2015","2150","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Celgene_website.pdf" "58","Thalomid","869","12/01/2015","2151","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Pharmacy_Guide.pdf" "58","Thalomid","869","12/01/2015","2152","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Education_Counseling_Checklist.pdf" "58","Thalomid","869","12/01/2015","2153","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","869","12/01/2015","2154","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","869","12/01/2015","2155","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_for_Adult_Male.pdf" "58","Thalomid","869","12/01/2015","2156","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_for_Male_Child.pdf" "58","Thalomid","869","12/01/2015","2157","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","869","12/01/2015","2158","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","869","12/01/2015","2159","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","869","12/01/2015","2160","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","869","12/01/2015","2161","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Patient_Guide.pdf" "58","Thalomid","869","12/01/2015","2162","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Emergency_Contraception_Brochure.pdf" "58","Thalomid","869","12/01/2015","2163","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","869","12/01/2015","2164","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","869","12/01/2015","2165","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","868","12/01/2015","2166","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_REMS_document.pdf" "46","Revlimid","868","12/01/2015","2167","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Prescriber_Enrollment_Form.pdf" "46","Revlimid","868","12/01/2015","2168","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Patient_Prescription_Form.pdf" "46","Revlimid","868","12/01/2015","2169","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Patient_Prescription_Form_VA.pdf" "46","Revlimid","868","12/01/2015","2170","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Prescriber_Guide.pdf" "46","Revlimid","868","12/01/2015","2171","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_At-A-Glance.pdf" "46","Revlimid","868","12/01/2015","2172","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Welcome_Letter.pdf" "46","Revlimid","868","12/01/2015","2173","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Celgene_website.pdf" "46","Revlimid","868","12/01/2015","2174","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Pharmacy_Guide.pdf" "46","Revlimid","868","12/01/2015","2175","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Education_Counseling_Checklist.pdf" "46","Revlimid","868","12/01/2015","2176","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Celgene_REMS_Programs_Pharmacy_Training.pdf" "46","Revlimid","868","12/01/2015","2177","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","868","12/01/2015","2178","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_for_Adult_Male.pdf" "46","Revlimid","868","12/01/2015","2179","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_for_Male_Child.pdf" "46","Revlimid","868","12/01/2015","2180","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","868","12/01/2015","2181","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","868","12/01/2015","2182","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","868","12/01/2015","2183","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","868","12/01/2015","2184","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Patient_Guide.pdf" "46","Revlimid","868","12/01/2015","2185","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Emergency_Contraception_Brochure.pdf" "46","Revlimid","868","12/01/2015","2186","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","868","12/01/2015","2187","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","868","12/01/2015","2188","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","868","12/01/2015","2189","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2015-12-01_REMS_full.pdf" "58","Thalomid","869","12/01/2015","2190","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2015-12-01_REMS_full.pdf" "41","Pomalyst","867","12/01/2015","2191","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_REMS_document.pdf" "41","Pomalyst","867","12/01/2015","2192","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","867","12/01/2015","2193","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Patient_Prescription_Form.pdf" "41","Pomalyst","867","12/01/2015","2194","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Patient_Prescription_Form_VA.pdf" "41","Pomalyst","867","12/01/2015","2195","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Prescriber_Guide.pdf" "41","Pomalyst","867","12/01/2015","2196","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_At-A-Glance.pdf" "41","Pomalyst","867","12/01/2015","2197","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Welcome_Letter.pdf" "41","Pomalyst","867","12/01/2015","2198","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Celgene_website.pdf" "41","Pomalyst","867","12/01/2015","2199","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Pharmacy_Guide.pdf" "41","Pomalyst","867","12/01/2015","2200","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Education_Counseling_Checklist.pdf" "41","Pomalyst","867","12/01/2015","2201","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","867","12/01/2015","2202","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","867","12/01/2015","2203","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_for_Adult_Male.pdf" "41","Pomalyst","867","12/01/2015","2204","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_for_Male_Child.pdf" "41","Pomalyst","867","12/01/2015","2205","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","867","12/01/2015","2206","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","867","12/01/2015","2207","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","867","12/01/2015","2208","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","867","12/01/2015","2209","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Patient_Guide.pdf" "41","Pomalyst","867","12/01/2015","2210","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","867","12/01/2015","2211","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Patient_Survey_Reminder_Card.pdf" "41","Pomalyst","867","12/01/2015","2212","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","867","12/01/2015","2213","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-01_Patient_Resource_Pack_Envelope.pdf" "41","Pomalyst","867","12/01/2015","2214","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2015-12-1_REMS_full.pdf" "49","Soliris","870","12/03/2015","2215","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_REMS_full.pdf" "49","Soliris","870","12/03/2015","2216","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_REMS_document.pdf" "49","Soliris","870","12/03/2015","2217","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_Dosing_Administration_Guide.pdf" "49","Soliris","870","12/03/2015","2218","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_Introductory_Letter_Enrollment_Form.pdf" "49","Soliris","870","12/03/2015","2219","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_Patient_Safety_Brochure.pdf" "49","Soliris","870","12/03/2015","2220","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_Patient_Safety_Card.pdf" "49","Soliris","870","12/03/2015","2221","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_Prescriber_Safety_Brochure.pdf" "49","Soliris","870","12/03/2015","2222","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2015-12-03_REMS_website_screenshot.pdf" "149","Adempas","871","12/04/2015","2224","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_REMS_full.pdf" "149","Adempas","871","12/04/2015","2225","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_REMS_document.pdf" "149","Adempas","871","12/04/2015","2226","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Prescriber_Enrollment_Agreement_Form.pdf" "149","Adempas","871","12/04/2015","2227","Prescriber and Pharmacy Guide for the Adempas REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Prescriber_Pharmacy_Guide.pdf" "149","Adempas","871","12/04/2015","2228","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "149","Adempas","871","12/04/2015","2229","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Patient_Enrollment_Consent_Form.pdf" "149","Adempas","871","12/04/2015","2230","Change in Reproductive Potential Status and Prepubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Change_Reproductive_Potential_Status.pdf" "149","Adempas","871","12/04/2015","2231","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_REMS_website_screenshot.pdf" "149","Adempas","871","12/04/2015","2232","Patient Enrollment and Consent Form for the Veterans Administration (V.A.)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Patient_Enrollment_Consent_Form_VA.pdf" "149","Adempas","871","12/04/2015","2233","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2015-12-04_Inpatient_Pharmacy_Enrollment_Form.pdf" "61","Tracleer","872","12/04/2015","2235","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_REMS_full.pdf" "61","Tracleer","872","12/04/2015","2236","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_REMS_document.pdf" "61","Tracleer","872","12/04/2015","2237","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Prescriber_Enrollment_Agreement_Form.pdf" "61","Tracleer","872","12/04/2015","2238","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Patient_Enrollment_Consent_Form.pdf" "61","Tracleer","872","12/04/2015","2239","Prescriber and Pharmacy Guide for the Tracleer REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Prescriber_Pharmacy_Guide.pdf" "61","Tracleer","872","12/04/2015","2240","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Guide_for_Patients.pdf" "61","Tracleer","872","12/04/2015","2241","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Change_Reproductive_Potential_Status.pdf" "61","Tracleer","872","12/04/2015","2242","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_DHCP_Letter.pdf" "61","Tracleer","872","12/04/2015","2243","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_REMS_website_screenshot.pdf" "61","Tracleer","872","12/04/2015","2244","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2015-12-04_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2245","Pharmacy Enrollment Form (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_CHAIN_OUTPATIENT_PHARMACY_ENROLLMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2246","Pharmacy Enrollment Form (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_CLOSED_SYSTEM_OUTPATIENT_PHARMACY_ENROLLMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2247","Dear Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_DEAR_DISTRIBUTOR_LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2248","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_DEAR_HEALTHCARE_PROVIDER_LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2249","Dear Pharmacy Letters (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_DEAR_INPATIENT_PHARMACY_LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2250","Dear Pharmacy Letters (Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_DEAR_OUTPATIENT_PHARMACY_LETTER.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2251","TIRF REMS Access Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_EDUCATION_PROGRAM_FOR_PRESCRIBERS_AND_PHARMACISTS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2252","Frequently Asked Questions (FAQs)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_FREQUENTLY_ASKED_QUESTIONS_FAQs.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2253","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_SS_2015-12-21_REMS_FULL.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2254","Pharmacy Enrollment Form (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_INDEPENDENT_OUTPATIENT_PHARMACY_ENROLLMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2255","Pharmacy Enrollment Form (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_INPATIENT_PHARMACY_ENROLLMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2256","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_KNOWLEDGE_ASSESSMENT.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2257","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PATIENT_PRESCRIBER_AGREEMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2258","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PRESCRIBER_ENROLLMENT_FORM.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2259","TIRF REMS Access Patient and Caregiver Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_PATIENTS_AND_CAREGIVERS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2260","The TIRF REMS Access Program Overview (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_CHAIN_OUTPATIENT_PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2261","The TIRF REMS Access Program Overview (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_CLOSED_SYSTEM_OUTPATIENT_PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2262","The TIRF REMS Access Program Overview (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_INDEPENDENT_OUTPATIENT_PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2263","The TIRF REMS Access Program Overview (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_INPATIENT_PHARMACIES.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2264","TIRF REMS Access Prescriber Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_PROGRAM_OVERVIEW_FOR_PRESCRIBERS.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2265","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_REMS_DOCUMENT.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2266","TIRF REMS Access Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_REMS_WEBSITE_SCREENSHOT.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","2267","Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2015-12-21_WHOLESALER_DISTRIBUTOR_ENROLLMENT_FORM.pdf" "155","Actoplus Met XR","256","05/12/2009","2268","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Actoplus_Met_XR_2009-05-12_REMS_Document.pdf" "172","Cimzia","364","11/18/2009","2269","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Cimzia_2009-11-18_REMS_Document.pdf" "199","HalfLytely Bisacodyl Bowel Prep Kit","410","07/16/2010","2271","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/HalfLytely_2010-07-16_REMS_Document.pdf" "30","Lumizyme","77","09/12/2011","2272","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumizyme_2011-09-12_REMS_Document.pdf" "214","Nucynta ER","451","08/25/2011","2273","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Nucynta_2011-08-25_REMS_Document.pdf" "258","Roferon-A Interferon","554","08/28/2009","2274","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Roferon-A_2009-08-28_REMS_Document.pdf" "180","Serevent Diskus","565","05/10/2011","2275","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Serevent_Diskus_2010-05-10_REMS_Document.pdf" "265","Silenor","575","03/17/2010","2276","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Silenor_2010-03-17_REMS_Document.pdf" "292","Vimpat","655","10/28/2008","2277","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vimpat_2008-10-10_REMS_Document.pdf" "294","Votrient","665","04/27/2010","2278","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Votrient_2010-04-27_REMS_Document.pdf" "174","Copegus","294","06/09/2010","2279","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copegus_2010-06-09_REMS_Document.pdf" "305","Zortress","692","04/20/2010","2280","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zortress_2010-04-20_REMS_Document.pdf" "67","Vivitrol","877","12/08/2015","2281","DHCP Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015-12-08_DHCP_Letter.pdf" "67","Vivitrol","877","12/08/2015","2282","Patient Counseling Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015-12-08_Patient_Counseling_Tool.pdf" "67","Vivitrol","877","12/08/2015","2283","Key Techniques to Reduce Severe Injection Site Reactions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015-12-08_Key_Techniques_to_Reduce_Severe_Injection_Site_Reactions.pdf" "67","Vivitrol","877","12/08/2015","2284","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015-12-08_REMS_Website_Screenshot.pdf" "67","Vivitrol","877","12/08/2015","2285","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015_12-08_REMS_Document.pdf" "67","Vivitrol","877","12/08/2015","2286","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2015-12-08_REMS_Full.pdf" "217","Lamictal","878","04/23/2009","2288","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lamictal_2009-04-23_REMS_Document.pdf" "229","Myobloc","484","08/05/2009","2289","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myobloc_2009-08-05_REMS_Document.pdf" "266","Simponi","578","11/18/2009","2290","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Simponi_2009-11-18_REMS_Document.pdf" "218","Lamictal XR","463","05/29/2009","2291","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/LamictalXR_2009-05-29_REMS_Document.pdf" "29","Lotronex","881","01/07/2016","2292","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_Letter_for_Healthcare_Providers .pdf" "29","Lotronex","881","01/07/2016","2293","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_LOTRONEX_REMS_Program_Prescriber_Education_Slide_Deck.pdf" "29","Lotronex","881","01/07/2016","2294","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_LOTRONEX_REMS_Program_Safety_Information_Fact_Sheet_For_Prescribers.pdf" "29","Lotronex","881","01/07/2016","2295","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_LOTRONEX_REMS_Program_Patient_Education_Sheet.pdf" "29","Lotronex","881","01/07/2016","2296","Prescriber Completion of LOTRONEX REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_Prescriber_Completion_of_LOTRONEX_REMS_Program_Training_Form .pdf" "29","Lotronex","881","01/07/2016","2297","REMS Website for Prescribers Section Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_Website_for_Prescribers_Section_Screenshots .pdf" "29","Lotronex","881","01/07/2016","2298","REMS Website for Patients Section Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_Website_for_Patients_Section_Screenshots .pdf" "29","Lotronex","881","01/07/2016","2299","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_Letter_for_Professional_Societies .pdf" "29","Lotronex","881","01/07/2016","2300","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_full.pdf" "29","Lotronex","881","01/07/2016","2301","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-01-07_REMS_Document .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2302","REMS Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_REMS_Letter_to_Healthcare_Providers .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2303","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Alosetron_REMS_Program_Prescriber_Education_Slide_Deck.pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2304","Program Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Alosetron_REMS_Program_Safety_Information_Fact_Sheet_For_Prescribers .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2305","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Alosetron_REMS_Program_Patient_Education_Sheet .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2306","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2307","REMS Website Prescriber Section Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Alosetron_REMS_Website_Prescriber_Section_Screenshots .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2308","REMS Website Patients Section Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_Alosetron_REMS_Program_Website_Patients_Section_Screenshots .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2309","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_REMS_Letter_for_Professional_Societies .pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2310","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_REMS_full.pdf" "347","Alosetron (moved to shared system, do not use)","882","01/07/2016","2311","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-01-07_REMS_Document .pdf" "342","Saxenda","884","02/01/2016","2312","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_Letter_Healthcare_Providers.pdf" "342","Saxenda","884","02/01/2016","2313","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_Letter_Professional_Societies.pdf" "342","Saxenda","884","02/01/2016","2314","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_Factsheet.pdf" "342","Saxenda","884","02/01/2016","2315","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_Slides.pdf" "342","Saxenda","884","02/01/2016","2316","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_website_screenshot.pdf" "342","Saxenda","884","02/01/2016","2317","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_document.pdf" "342","Saxenda","884","02/01/2016","2318","REM full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2016-02-01_REMS_full.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2319","The Guide to Best Practices For the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_The_Guide_to_Best_Practices_For_the_iPLEDGE_Program.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2320","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Prescriber_Contraception_Counseling Guide.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2321","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_DVDs_for_prescriber_use_in_patient_counseling_Be_Prepared_Be_Protected_and_Be_Aware_The_Risk_of_Pregnancy_While_on_Isotretinoin.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2322","Recognizing Psychiatric Disorders In Adolescents And Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Recognizing_Psychiatric_Disorders_In_Adolescents_And_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2323","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Request_for_Exemption_for_Patients_with_Serious_Medical_Reasons.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2324","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Office_Staff_Designee_Registration_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2325","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Instructions_for_Managing_Office_Staff_Designees.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2326","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2327","Pharmacist Guide for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Pharmacist_Guide_for_the_iPLEDGE_Program.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2328","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2329","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Guide_to_Isotretinoin_for_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2330","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Guide_to_Isotretinoin_for_Male_Patients_and_Female_Patients_who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2331","The iPLEDGE Program Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_The_iPLEDGE_Program_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2332","Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Isotretinoin_Educational_Kit_for_Males_and_Females_of_Non_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2333","Isotretinoin Educational Kit for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Isotretinoin_Educational_Kit_for_Females_of_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2334","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Patient_Information_Informed_Consent_for_all_patients.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2335","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Patient_Information_Informed_Consent_for_Females_of_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2336","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Patient_Monthly_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2337","iPLEDGE Program wholesaler agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_iPLEDGE_Program_wholesaler_agreement.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2338","Wholesaler to wholesaler shipment request form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Wholesaler_to_wholesaler_shipment_request_form.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2339","REMs document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2340","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_REMS_full.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2341","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_REMS_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","885","02/04/2016","2342","Isotretinoin Educational Kit for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-02-04_Isotretinoin_Educational_Kit_for_Prescribers.pdf" "76","Opsumit","888","02/22/2016","2343","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_REMS_full.pdf" "76","Opsumit","888","02/22/2016","2344","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_REMS_document.pdf" "76","Opsumit","888","02/22/2016","2345","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Patient_Enrollment_Consent Form.pdf" "76","Opsumit","888","02/22/2016","2346","Patient Enrollment and Consent Form - for VA use only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Patient_Enrollment_Consent_Form_VA_only.pdf" "76","Opsumit","888","02/22/2016","2347","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "76","Opsumit","888","02/22/2016","2348","Prescriber and Pharmacy Guide for the Opsumit REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Prescriber_Pharmacy_Guide.pdf" "76","Opsumit","888","02/22/2016","2349","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Prescriber_Enrollment_Agreement_Form.pdf" "76","Opsumit","888","02/22/2016","2350","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Change_Reproductive_Potential_Status.pdf" "76","Opsumit","888","02/22/2016","2351","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_Inpatient_Pharmacy_Enrollment.pdf" "76","Opsumit","888","02/22/2016","2352","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2016-02-22_REMS_website_screenshot.pdf" "62","Truvada","889","02/25/2016","2353","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Journal_Information_Piece.pdf" "62","Truvada","889","02/25/2016","2354","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Dear_Healthcare_Provider_Letter.pdf" "62","Truvada","889","02/25/2016","2355","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Training_Guide_for_Healthcare_Providers.pdf" "62","Truvada","889","02/25/2016","2356","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Healthcare_Provider_Education_Slide_Deck.pdf" "62","Truvada","889","02/25/2016","2357","Important Safety Information about TRUVADA for a PrEP Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Important_Safety_Information_about_TRUVADA_for_a_PrEP_Indication_for_Healthcare_Providers.pdf" "62","Truvada","889","02/25/2016","2358","Important Safety Information about TRUVADA to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Important_Safety_Information_about_TRUVADA_to_Reduce_the_Risk_of_Getting_Human_Immunodeficiency_Virus-1_HIV-1_Infection.pdf" "62","Truvada","889","02/25/2016","2359","Agreement Form for Initiating TRUVADA for Pre-Exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Agreement_Form_for_Initiating_TRUVADA_for_Pre_Exposure_Prophylaxis_PrEP.pdf" "62","Truvada","889","02/25/2016","2360","Checklist for Prescribers: Initiation of TRUVADA for Pre-exposure Prophylaxis (PrEP) to manage an uninfected individual considering or taking TRUVADA for a PrEP indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Checklist_for_Prescribers_Initiation_of_TRUVADA_for_Pre_exposure_Prophylaxis_PrEP_to_manage_an_uninfected_individual_considering_or_taking_TRUVADA_for_a_PrEP_indication.pdf" "62","Truvada","889","02/25/2016","2361","Safety Information Fact Sheet for Prescribers about TRUVADA for a Pre-exposure Prophylaxis (PrEP) Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_Safety_Information_Fact_Sheet_for_Prescribers_about_TRUVADA_for_a_Preexposure_Prophylaxis_PrEP_Indication.pdf" "62","Truvada","889","02/25/2016","2362","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_REMS_full.pdf" "62","Truvada","889","02/25/2016","2363","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_REMS_document.pdf" "62","Truvada","889","02/25/2016","2364","REMS website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-02-25_REMS_Website_Screenshots.pdf" "62","Truvada","891","03/10/2016","2367","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Journal_Information_Piece.pdf" "62","Truvada","891","03/10/2016","2368","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Dear_Healthcare_Provider_Letter.pdf" "62","Truvada","891","03/10/2016","2369","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Training_Guide_for_Healthcare_Providers.pdf" "62","Truvada","891","03/10/2016","2370","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Healthcare_Provider_Education_Slide_Deck.pdf" "62","Truvada","891","03/10/2016","2371","Important Safety Information about TRUVADA for a PrEP Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Important_Safety_Information_about_TRUVADA_for_a_PrEP_Indication_for_Healthcare_Providers.pdf" "62","Truvada","891","03/10/2016","2372","Important Safety Information about TRUVADA to Reduce the Risk of Getting Human Immunodeficiency Virus-1 HIV-1 Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Important_Safety_Information_about_TRUVADA_to_Reduce_the_Risk_of_Getting_Human_Immunodeficiency_Virus-1_HIV-1_Infection.pdf" "62","Truvada","891","03/10/2016","2373","Agreement Form for Initiating TRUVADA for Pre Exposure Prophylaxis PrEP","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Agreement_Form_for_Initiating_TRUVADA_for_Pre_Exposure_Prophylaxis_PrEP.pdf" "62","Truvada","891","03/10/2016","2374","Checklist for Prescribers Initiation of TRUVADA for Pre exposure Prophylaxis PrEP to manage an uninfected individual considering or taking TRUVADA for a PrEP indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Checklist_for_Prescribers_Initiation_of_TRUVADA_for_Pre_exposure_Prophylaxis_PrEP_to_manage_an_uninfected_individual_considering_or_taking_TRUVADA_for_a_PrEP_indication.pdf" "62","Truvada","891","03/10/2016","2375","Safety Information Fact Sheet for Prescribers about TRUVADA for a Preexposure Prophylaxis PrEP Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_Safety_Information_Fact_Sheet_for_Prescribers_about_TRUVADA_for_a_Preexposure_Prophylaxis_PrEP_Indication.pdf" "62","Truvada","891","03/10/2016","2376","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_REMS_document.pdf" "62","Truvada","891","03/10/2016","2377","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_REMS_full.pdf" "62","Truvada","891","03/10/2016","2378","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2016-03-10_REMS_Website_Screenshots.pdf" "65","Vibativ","892","03/23/2016","2379","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vibativ_2016-03-23_REMS_document.pdf" "65","Vibativ","892","03/23/2016","2380","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vibativ_2016-03-23_REMS_full.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2381","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_REMS_document.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2382","REMS letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_REMS_letter_Healthcare_Providers.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2383","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_Prescriber_Education_Slide_Deck.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2384","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_Safety_Information_Fact_Sheet.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2385","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_Patient_Education_Sheet.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2386","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_Prescriber_Completion_Training_Form.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2387","REMS website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_website_screenshot.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2388","REMS letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_REMS_letter_Professional_Societies.pdf" "347","Alosetron (moved to shared system, do not use)","893","03/24/2016","2389","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/alosetron_2016-03-24_REMS_full.pdf" "35","Mifeprex","894","03/29/2016","2390","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_document.pdf" "35","Mifeprex","894","03/29/2016","2391","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf" "35","Mifeprex","894","03/29/2016","2392","Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Prescriber_Agreement_Form.pdf" "35","Mifeprex","894","03/29/2016","2393","Patient Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Patient_Agreement_Form.pdf" "319","Afrezza","895","04/01/2016","2394","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_full.pdf" "319","Afrezza","895","04/01/2016","2395","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_document.pdf" "319","Afrezza","895","04/01/2016","2396","Letter for Healthcare Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_Letter_Healthcare_Providers_print.pdf" "319","Afrezza","895","04/01/2016","2397","Letter for Healthcare Providers (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_Letter_Healthcare_Providers_email.pdf" "319","Afrezza","895","04/01/2016","2398","Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_Letter_Professional_Societies_print.pdf" "319","Afrezza","895","04/01/2016","2399","Letter for Professional Societies (email version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_Letter_Professional_Societies_email.pdf" "319","Afrezza","895","04/01/2016","2400","Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_Factsheet.pdf" "319","Afrezza","895","04/01/2016","2401","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_website_screenshot.pdf" "350","Addyi","896","04/08/2016","2402","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Knowledge_Assessment.pdf" "350","Addyi","896","04/08/2016","2403","Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Prescriber_and_Pharmacy_Training.pdf" "350","Addyi","896","04/08/2016","2404","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Prescriber_Enrollment_Form.pdf" "350","Addyi","896","04/08/2016","2405","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_REMS_Website_Screenshots.pdf" "350","Addyi","896","04/08/2016","2406","Patient Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Patient_Provider_Agreement_Form.pdf" "350","Addyi","896","04/08/2016","2407","Multiple Locations Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Multiple_Locations_Pharmacy_Enrollment_Form.pdf" "350","Addyi","896","04/08/2016","2408","Individual Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Individual_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","896","04/08/2016","2409","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_Inpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","896","04/08/2016","2410","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_REMS_document.pdf" "350","Addyi","896","04/08/2016","2411","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-04-08_REMS_full.pdf" "340","Lemtrada","897","04/05/2016","2412","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Full.pdf" "340","Lemtrada","897","04/05/2016","2413","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_REMS_document.pdf" "340","Lemtrada","897","04/05/2016","2414","The REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_DHCP_Letter.pdf" "340","Lemtrada","897","04/05/2016","2415","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_REMS_website_screenshots.pdf" "340","Lemtrada","897","04/05/2016","2416","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Program_Overview.pdf" "340","Lemtrada","897","04/05/2016","2417","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Education_Program_Prescribers.pdf" "340","Lemtrada","897","04/05/2016","2418","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Knowledge_Assessment.pdf" "340","Lemtrada","897","04/05/2016","2419","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","897","04/05/2016","2420","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Enrollment_Form.pdf" "340","Lemtrada","897","04/05/2016","2421","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Status_Form.pdf" "340","Lemtrada","897","04/05/2016","2422","What You Need to Know About Lemtrada Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_A_Patient_Guide.pdf" "340","Lemtrada","897","04/05/2016","2423","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Prescription_Ordering_Form.pdf" "340","Lemtrada","897","04/05/2016","2424","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Authorization_Baseline_Lab_Form.pdf" "340","Lemtrada","897","04/05/2016","2425","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Status_Reminder_Letter.pdf" "340","Lemtrada","897","04/05/2016","2426","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","897","04/05/2016","2427","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","897","04/05/2016","2428","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Education_Program_Healthcare_Facilities.pdf" "340","Lemtrada","897","04/05/2016","2429","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Infusion_Checklist.pdf" "340","Lemtrada","897","04/05/2016","2430","What You Need to Know about LEMTRADA Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Infusion_Reactions_A_Patient_Guide.pdf" "340","Lemtrada","897","04/05/2016","2432","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Safety_Information_Card.pdf" "49","Soliris","898","04/13/2016","2434","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_REMS_full.pdf" "49","Soliris","898","04/13/2016","2435","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_REMS_document.pdf" "49","Soliris","898","04/13/2016","2436","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_Patient_Safety_Card.pdf" "49","Soliris","898","04/13/2016","2437","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_Enrollment_Form.pdf" "49","Soliris","898","04/13/2016","2438","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_Patient_Safety_Brochure.pdf" "49","Soliris","898","04/13/2016","2439","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_Prescriber_Safety_Brochure.pdf" "49","Soliris","898","04/13/2016","2440","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_Dosing_Administration_Guide.pdf" "49","Soliris","898","04/13/2016","2441","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-04-13_REMS_website.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2442","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_REMS_document.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2443","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Patient_Counseling_Document.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2444","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_FDA_Blueprint .pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2445","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2446","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2447","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2448","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Professional_Organization_Letter_1.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2449","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_Professional_Organization_Letter_2.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2450","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_REMS_website_screenshot.pdf" "17","Opioid Analgesic REMS","900","04/20/2016","2451","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-20_REMS_full.pdf" "41","Pomalyst","902","04/22/2016","2452","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_REMS_document.pdf" "41","Pomalyst","902","04/22/2016","2453","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","902","04/22/2016","2454","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Patient_Prescription_Form.pdf" "41","Pomalyst","902","04/22/2016","2455","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Patient_Prescription_Form_VA.pdf" "41","Pomalyst","902","04/22/2016","2456","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Prescriber_Guide.pdf" "41","Pomalyst","902","04/22/2016","2457","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_At-A-Glance.pdf" "41","Pomalyst","902","04/22/2016","2458","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Welcome_Letter.pdf" "41","Pomalyst","902","04/22/2016","2459","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Celgene_website.pdf" "41","Pomalyst","902","04/22/2016","2460","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Pharmacy_Guide.pdf" "41","Pomalyst","902","04/22/2016","2461","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Education_Counseling_Checklist.pdf" "41","Pomalyst","902","04/22/2016","2462","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","902","04/22/2016","2463","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","902","04/22/2016","2464","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_for_Adult_Male.pdf" "41","Pomalyst","902","04/22/2016","2465","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_for_Male_Child.pdf" "41","Pomalyst","902","04/22/2016","2466","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","902","04/22/2016","2467","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","902","04/22/2016","2468","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","902","04/22/2016","2469","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","902","04/22/2016","2470","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Patient_Guide.pdf" "41","Pomalyst","902","04/22/2016","2471","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","902","04/22/2016","2472","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Patient_Survey_Reminder_Card.pdf" "41","Pomalyst","902","04/22/2016","2473","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","902","04/22/2016","2474","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","903","04/22/2016","2475","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_REMS_document.pdf" "46","Revlimid","903","04/22/2016","2476","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Prescriber_Enrollment_Form.pdf" "46","Revlimid","903","04/22/2016","2477","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Patient_Prescription_Form.pdf" "46","Revlimid","903","04/22/2016","2478","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Patient_Prescription_Form_VA.pdf" "46","Revlimid","903","04/22/2016","2479","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Prescriber_Guide.pdf" "46","Revlimid","903","04/22/2016","2480","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_At-A-Glance.pdf" "46","Revlimid","903","04/22/2016","2481","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Welcome_Letter.pdf" "46","Revlimid","903","04/22/2016","2482","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Celgene_website.pdf" "46","Revlimid","903","04/22/2016","2483","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Pharmacy_Guide.pdf" "46","Revlimid","903","04/22/2016","2484","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Education_Counseling_Checklist.pdf" "46","Revlimid","903","04/22/2016","2485","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Celgene_REMS_Programs_Pharmacy_Training.pdf" "46","Revlimid","903","04/22/2016","2486","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","903","04/22/2016","2487","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_for_Adult_Male.pdf" "46","Revlimid","903","04/22/2016","2488","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_for_Male_Child.pdf" "46","Revlimid","903","04/22/2016","2489","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","903","04/22/2016","2490","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","903","04/22/2016","2491","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","903","04/22/2016","2492","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","903","04/22/2016","2493","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Patient_Guide.pdf" "46","Revlimid","903","04/22/2016","2494","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Emergency_Contraception_Brochure.pdf" "46","Revlimid","903","04/22/2016","2495","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","903","04/22/2016","2496","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","903","04/22/2016","2497","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","904","04/22/2016","2498","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_REMS_document.pdf" "58","Thalomid","904","04/22/2016","2499","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Prescriber_Enrollment_Form.pdf" "58","Thalomid","904","04/22/2016","2500","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Patient_Prescription_Form.pdf" "58","Thalomid","904","04/22/2016","2501","Patient Prescription Form (Veterans Administration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Patient_Prescription_Form_VA.pdf" "58","Thalomid","904","04/22/2016","2502","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Prescriber_Guide.pdf" "58","Thalomid","904","04/22/2016","2503","Thalomid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_At-A-Glance.pdf" "58","Thalomid","904","04/22/2016","2504","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Welcome_Letter.pdf" "58","Thalomid","904","04/22/2016","2505","Celgene risk management website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Celgene_website.pdf" "58","Thalomid","904","04/22/2016","2506","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Pharmacy_Guide.pdf" "58","Thalomid","904","04/22/2016","2507","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Education_Counseling_Checklist.pdf" "58","Thalomid","904","04/22/2016","2508","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","904","04/22/2016","2509","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","904","04/22/2016","2510","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_for_Adult_Male.pdf" "58","Thalomid","904","04/22/2016","2511","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_for_Male_Child.pdf" "58","Thalomid","904","04/22/2016","2512","Patient-Physician Agreement Form Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","904","04/22/2016","2513","Patient-Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","904","04/22/2016","2514","Patient-Physician Agreement Form Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","904","04/22/2016","2515","Patient-Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","904","04/22/2016","2516","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Patient_Guide.pdf" "58","Thalomid","904","04/22/2016","2517","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Emergency_Contraception_Brochure.pdf" "58","Thalomid","904","04/22/2016","2518","Patient Survery Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","904","04/22/2016","2519","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","904","04/22/2016","2520","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","904","04/22/2016","2521","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2016-04-22_Full.pdf" "46","Revlimid","903","04/22/2016","2522","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2016-04-22_Full.pdf" "41","Pomalyst","902","04/22/2016","2523","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2016-04-22_Full.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2524","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-04-26_REMS_full.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2525","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_REMS_document.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2526","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Patient_Counseling_Document.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2527","FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2528","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2529","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2530","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2531","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Professional_Organization_Letter_1.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2532","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_Professional_Organization_Letter_2.pdf" "17","Opioid Analgesic REMS","906","04/26/2016","2533","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioids_2016-04-26_REMS_website_screenshot.pdf" "29","Lotronex","907","04/29/2016","2534","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_full.pdf" "29","Lotronex","907","04/29/2016","2535","REM document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_document.pdf" "29","Lotronex","907","04/29/2016","2536","REMS letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_letter_healthcare_Providers.pdf" "29","Lotronex","907","04/29/2016","2537","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Prescriber_Education_Slide_Deck.pdf" "29","Lotronex","907","04/29/2016","2538","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Safety_Information_Fact_Sheet.pdf" "29","Lotronex","907","04/29/2016","2539","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Patient_Education_Sheet.pdf" "29","Lotronex","907","04/29/2016","2540","Prescriber Completion of LOTRONEX REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Prescriber_Completion_Training_Form.pdf" "29","Lotronex","907","04/29/2016","2541","REMS letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_letter_Professional_Societies.pdf" "29","Lotronex","907","04/29/2016","2542","REMS website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_website_screenshots.pdf" "350","Addyi","908","05/10/2016","2543","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_REMS_full.pdf" "350","Addyi","908","05/10/2016","2544","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_REMS_document.pdf" "350","Addyi","908","05/10/2016","2545","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Prescriber_Enrollment_Form.pdf" "350","Addyi","908","05/10/2016","2546","Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Prescriber_Pharmacy_Training.pdf" "350","Addyi","908","05/10/2016","2547","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Knowledge_Assessment.pdf" "350","Addyi","908","05/10/2016","2548","REMS website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_REMS_website_screenshots.pdf" "350","Addyi","908","05/10/2016","2549","Patient-Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Patient-Provider_Agreement.pdf" "350","Addyi","908","05/10/2016","2550","Multiple Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Multiple_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","908","05/10/2016","2551","Individual Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Individual_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","908","05/10/2016","2552","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2016-05-10_Inpatient_Pharmacy_Enrollment_Form.pdf" "67","Vivitrol","909","05/17/2016","2553","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_REMS_full.pdf" "67","Vivitrol","909","05/17/2016","2554","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_REMS_document.pdf" "67","Vivitrol","909","05/17/2016","2555","Dear Healthcare Provider (DHCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_DHCP_Letter.pdf" "67","Vivitrol","909","05/17/2016","2556","Patient Counseling Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_Patient_Counseling_Tool.pdf" "67","Vivitrol","909","05/17/2016","2557","Key Techniques to Reduce Severe Injection Site Reactions poster","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_key_techniques_poster.pdf" "67","Vivitrol","909","05/17/2016","2558","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol_2016-05-17_REMS_website_screenshot.pdf" "15","Entereg","911","05/18/2016","2559","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_REMS_full.pdf" "15","Entereg","911","05/18/2016","2560","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_REMS_document.pdf" "15","Entereg","911","05/18/2016","2561","E.A.S.E. ENTEREG REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_Program_overview.pdf" "15","Entereg","911","05/18/2016","2562","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_DHCP.pdf" "15","Entereg","911","05/18/2016","2563","Prescriber and Pharmacist Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_Information_Brochure.pdf" "15","Entereg","911","05/18/2016","2564","Hospital Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-05-18_Pharmacy_Enrollment_Form.pdf" "356","Probuphine","912","05/26/2016","2565","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_REMS_full.pdf" "356","Probuphine","912","05/26/2016","2566","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_REMS_document.pdf" "356","Probuphine","912","05/26/2016","2567","What You Need to Know about Probuphine: A Patient’s Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Patient_Guide.pdf" "356","Probuphine","912","05/26/2016","2568","Slides for Live Training: Lecture and Practicum","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Slides_Live_Training.pdf" "356","Probuphine","912","05/26/2016","2569","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Knowledge_Assessment.pdf" "356","Probuphine","912","05/26/2016","2570","Insertion/Removal Log","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Insertion_Removal_Log.pdf" "356","Probuphine","912","05/26/2016","2571","REMS Program website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_REMS_website_screeshot.pdf" "356","Probuphine","912","05/26/2016","2572","Healthcare Provider Who Performs Probuphine Surgical Procedures","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Healthcare_Provider_Enrollment_Form.pdf" "356","Probuphine","912","05/26/2016","2573","Healthcare Provider Dual Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Healthcare_Provider_Dual_Enrollment_Form.pdf" "356","Probuphine","912","05/26/2016","2574","Criteria for Procedural Competency","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Criteria_Procedural_Competency.pdf" "356","Probuphine","912","05/26/2016","2575","Procedure Record for Recertification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Procedure_Record_Recertification.pdf" "356","Probuphine","912","05/26/2016","2576","Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Healthcare_Provider_Recertification_Form.pdf" "356","Probuphine","912","05/26/2016","2577","Surgical Procedures Recertification Video transcript","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Recertification_Video_transcript.pdf" "356","Probuphine","912","05/26/2016","2578","Healthcare Provider Who Prescribes Enrollment Form Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-05-26_Prescriber_Enrollment_Form.pdf" "357","Zinbryta","913","05/27/2016","2579","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_REMS_full.pdf" "357","Zinbryta","913","05/27/2016","2580","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_REMS_document.pdf" "357","Zinbryta","913","05/27/2016","2581","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Letter_for_Healthcare_Providers.pdf" "357","Zinbryta","913","05/27/2016","2582","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Program_Overview.pdf" "357","Zinbryta","913","05/27/2016","2583","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Prescriber_Training.pdf" "357","Zinbryta","913","05/27/2016","2584","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Prescriber_Enrollment_Form.pdf" "357","Zinbryta","913","05/27/2016","2585","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Prescriber_Knowledge_Assessment.pdf" "357","Zinbryta","913","05/27/2016","2586","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Patient_Enrollment_Form.pdf" "357","Zinbryta","913","05/27/2016","2587","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Patient_Status_Form.pdf" "357","Zinbryta","913","05/27/2016","2588","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Patient_Guide.pdf" "357","Zinbryta","913","05/27/2016","2589","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Patient_Wallet_Card.pdf" "357","Zinbryta","913","05/27/2016","2590","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Pharmacy_Enrollment_Form.pdf" "357","Zinbryta","913","05/27/2016","2591","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_REMS_website_screenshot.pdf" "357","Zinbryta","913","05/27/2016","2592","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2016-05-27_Patient_Status_Form.pdf" "21","Gattex","914","05/27/2016","2593","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_REMS_full.pdf" "21","Gattex","914","05/27/2016","2594","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_REMS_document.pdf" "21","Gattex","914","05/27/2016","2595","Dear Healthcare Professional letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_DHCP_letter.pdf" "21","Gattex","914","05/27/2016","2596","Dear Professional Society letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_Dear_Professional_Society_letter.pdf" "21","Gattex","914","05/27/2016","2597","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","914","05/27/2016","2598","What You Need to Know About Gattex Treatment: A Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_Patient_Caregiver_Counseling_Guide.pdf" "21","Gattex","914","05/27/2016","2599","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2016-05-27_REMS_website.pdf" "15","Entereg","915","06/01/2016","2600","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_REMS_full.pdf" "15","Entereg","915","06/01/2016","2601","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_REMS_document.pdf" "15","Entereg","915","06/01/2016","2602","E.A.S.E. ENTEREG REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Program_overview.pdf" "15","Entereg","915","06/01/2016","2603","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_DHCP.pdf" "15","Entereg","915","06/01/2016","2604","Prescriber and Pharmacist Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Information_Brochure.pdf" "15","Entereg","915","06/01/2016","2605","Hospital Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Pharmacy_Enrollment_Form.pdf" "356","Probuphine","916","06/14/2016","2606","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_REMS_full.pdf" "356","Probuphine","916","06/14/2016","2607","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_REMS_document.pdf" "356","Probuphine","916","06/14/2016","2608","Healthcare Provider Who Prescribes Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Prescriber_Enrollment_Form.pdf" "356","Probuphine","916","06/14/2016","2609","What You Need to Know about Probuphine: A Patient’s Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Patient_Guide.pdf" "356","Probuphine","916","06/14/2016","2610","Slides for Live Training: Lecture and Practicum","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Slides_Live_Training.pdf" "356","Probuphine","916","06/14/2016","2611","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Knowledge_Assessment.pdf" "356","Probuphine","916","06/14/2016","2612","Insertion/Removal Log","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Insertion_Removal_Log.pdf" "356","Probuphine","916","06/14/2016","2613","REMS Program website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_REMS_website_screeshot.pdf" "356","Probuphine","916","06/14/2016","2614","Healthcare Provider Who Performs Probuphine Surgical Procedures Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Healthcare_Provider_Enrollment_Form.pdf" "356","Probuphine","916","06/14/2016","2615","Healthcare Provider Dual Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Healthcare_Provider_Dual_Enrollment_Form.pdf" "356","Probuphine","916","06/14/2016","2616","Criteria for Procedural Competency","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Criteria_Procedural_Competency.pdf" "356","Probuphine","916","06/14/2016","2617","Procedure Record for Recertification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Procedure_Record_Recertification.pdf" "356","Probuphine","916","06/14/2016","2618","Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Healthcare_Provider_Recertification_Form.pdf" "356","Probuphine","916","06/14/2016","2619","Surgical Procedures Recertification Video transcript","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2016-06-14_Recertification_Video_transcript.pdf" "48","Sabril","917","06/21/2016","2620","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_REMS_document .pdf" "48","Sabril","917","06/21/2016","2621","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Full.pdf" "48","Sabril","917","06/21/2016","2622","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Prescriber_Enrollment_and_Agreement_Form .pdf" "48","Sabril","917","06/21/2016","2623","What You Need to Know About Sabril Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_What_You_Need_to_Know_About_Sabril_Treatment_A_Patient_Guide .pdf" "48","Sabril","917","06/21/2016","2624","Patient/Parent/Legal Guardian Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "48","Sabril","917","06/21/2016","2625","Letter for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Letter_for_Prescribers.pdf" "48","Sabril","917","06/21/2016","2626","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Pharmacy_Enrollment_Form .pdf" "48","Sabril","917","06/21/2016","2627","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_Letter_for_Pharmacists .pdf" "48","Sabril","917","06/21/2016","2628","Letter for Eye Care Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06_21_Letter_for_Eye_Care_Professionals.pdf" "48","Sabril","917","06/21/2016","2629","Fact Sheet for Eye Care Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06_21_Fact_Sheet_For_Eye_Care_Professionals .pdf" "48","Sabril","917","06/21/2016","2630","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-21_REMS_Website_Screenshots .pdf" "48","Sabril","918","06/27/2016","2631","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016_06-27_Prescriber_Enrollment_and_Agreement_Form.pdf" "48","Sabril","918","06/27/2016","2632","What You Need to Know About SABRIL Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_What You_Need_to_Know_About_SABRIL_Treatment_A_Patient_Guide.pdf" "48","Sabril","918","06/27/2016","2633","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "48","Sabril","918","06/27/2016","2634","Letter for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Letter_for_Prescribers.pdf" "48","Sabril","918","06/27/2016","2635","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Pharmacy_Enrollment Form.pdf" "48","Sabril","918","06/27/2016","2636","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Letter_for_Pharmacists.pdf" "48","Sabril","918","06/27/2016","2637","Letter for Eye Care Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Letter_for_Eye_Care_Professionals.pdf" "48","Sabril","918","06/27/2016","2638","Fact Sheet for Eye Care Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_Fact_Sheet_for_Eye_Care_Professionals.pdf" "48","Sabril","918","06/27/2016","2639","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016-06-27_REMS_Program_Website_Screenshots.pdf" "48","Sabril","918","06/27/2016","2640","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016_06_27_Full.pdf" "48","Sabril","918","06/27/2016","2641","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sabril_2016_06_27_REMS_Document .pdf" "352","Suboxone/Subutex","919","07/07/2016","2642","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","919","07/07/2016","2643","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","919","07/07/2016","2644","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","919","07/07/2016","2645","Prescriber Brochure, “Office‐Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_Prescriber_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","919","07/07/2016","2646","Pharmacist Brochure, “Office‐Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_Pharmacist_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","919","07/07/2016","2647","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_REMS_Website_Screenshots.pdf" "352","Suboxone/Subutex","919","07/07/2016","2648","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016-07-07_REMS_Document .pdf" "352","Suboxone/Subutex","919","07/07/2016","2649","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2016_07-07_Full.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2660","Prescriber Istoretinoin Educational Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Prescriber_Isotretinoin_Educational_Kit .pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2661","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2662","The Guide to Best Practices For the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_The_Guide_To_Best_Practices_For_The_iPledge_Program.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2663","Recognizing Psychiatric Disorders In Adolescents And Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Recognizing_Psychiatric_Disorders_In_Adolescents_And_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2664","DVDs for Prescriber Use in Patient Counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Transcript_DVD_Be_Aware_Be_Prepared_Be_Protected.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2665","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Request_for_Exemption_for_Patients_With_Serious_Medical_Reasons.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2666","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Instructions_for_Managing_Office_Staff_Designees.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2667","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Office_Staff_Designee_Registration_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2668","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin 2016-07-08_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2669","Pharmacist Guide for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Pharmacist_Guide_for_the_iPledge_Program.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2670","The iPLEDGE Program Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2671","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2672","Isotretinoin Educational Kit for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Educational_Kit_For_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2673","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Guide_To_Isotretinoin_For_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2674","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Patient_Information_Informed_Consent_for_All_Patients.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2675","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Patient_Information_Informed_Consent_About_Birth_Defects_For_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2676","Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Educational_Kit_For_Male_Patients_And_Female_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2677","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Guide_To_Isotretinoin_For_Male_Patients_And_Female_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2678","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Patient_Monthly_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2679","Wholesaler to Wholesaler Shipment Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Wholesaler_to_Wholesaler_Shipment_Request_Form.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2680","iPLEDGE Program Wholesaler Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Wholesaler_Agreement.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2681","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_REMS_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2682","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","921","07/08/2016","2683","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2016-07-08_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2684","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2685","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2686","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2687","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Important_Information_for_Prescribers.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2688","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Important_Information_for_Pharmacists.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2689","BTOD REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_REMS_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2690","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","2691","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-07_REMS_Document .pdf" "49","Soliris","924","07/12/2016","2692","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_REMS_full.pdf" "49","Soliris","924","07/12/2016","2693","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_REMS_document.pdf" "49","Soliris","924","07/12/2016","2694","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_Patient_Safety_Card.pdf" "49","Soliris","924","07/12/2016","2695","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_Enrollment_Form.pdf" "49","Soliris","924","07/12/2016","2696","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_Patient_Safety_Brochure.pdf" "49","Soliris","924","07/12/2016","2698","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_Dosing_Administration_Guide.pdf" "49","Soliris","924","07/12/2016","2699","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_REMS_website.pdf" "49","Soliris","924","07/12/2016","2700","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2016-07-12_Prescriber_Safety_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2701","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_Dear_Prescriber_Letter .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2702","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_Dear_Pharmacist_Letter .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2703","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_Appropriate_Use_Checklist .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2704","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_Important_Information_for_Prescribers.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2705","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_Important_Information_for_Pharmacists .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2706","BTOD REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_REMS_Website_Screenshots .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2707","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","2708","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-07-27_REMS_Document .pdf" "12","Chantix","926","08/12/2016","2709","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Chantix_2016-08-12_REMS_document.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2711","Patient Counseling Document (PCD) on Extended-Release/Long-Acting Opioid Analgesics","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Patient_Counseling_Document.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2712","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2713","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2714","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2715","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Professional_Organization_Letter_1.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2716","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_Professional_Organization_Letter_2.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2717","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_REMS_document.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2718","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_REMS_full.pdf" "17","Opioid Analgesic REMS","928","08/19/2016","2719","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_opioid_2016-08-19_REMS_website_screenshot.pdf" "341","Blincyto","929","08/30/2016","2720","Fact sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_Fact_sheet.pdf" "341","Blincyto","929","08/30/2016","2721","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_Letter_for_Healthcare Providers.pdf" "341","Blincyto","929","08/30/2016","2722","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_Letter_for_Hospital_Home_Healthcare_Pharmacists.pdf" "341","Blincyto","929","08/30/2016","2723","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_Letter_for_Professional_Societies.pdf" "341","Blincyto","929","08/30/2016","2724","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_REMS_document.pdf" "341","Blincyto","929","08/30/2016","2725","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_REMS_website_screenshot.pdf" "341","Blincyto","929","08/30/2016","2726","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2016-08-30_REMS_full.pdf" "66","Victoza","931","09/20/2016","2735","REMS Letter for Healthcare Providers (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_Letter_for_Healthcare_Providers_Print_Version .pdf" "66","Victoza","931","09/20/2016","2736","REMS Letter for Professional Societies (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_Letter_for_Professional_Societies_Print_Version .pdf" "66","Victoza","931","09/20/2016","2737","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_Factsheet .pdf" "66","Victoza","931","09/20/2016","2738","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_REMS_Slides .pdf" "66","Victoza","931","09/20/2016","2739","REMS Website Screenshot (Landing Page)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_REMS_Website_Screenshot_Landing_Page .pdf" "66","Victoza","931","09/20/2016","2740","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_REMS_Document .pdf" "66","Victoza","931","09/20/2016","2741","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Victoza_2016-09-20_Full.pdf" "63","Tysabri","932","09/22/2016","2742","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_REMS_Document .pdf" "63","Tysabri","932","09/22/2016","2743","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Full.pdf" "63","Tysabri","932","09/22/2016","2744","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Educational_Slide_Set .pdf" "63","Tysabri","932","09/22/2016","2745","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Program_Overview .pdf" "63","Tysabri","932","09/22/2016","2746","Pre-Infusion Patient Checklist (combined MS and CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Pre_Infusion_Patient_Checklist_Combined_MS_and_CD.pdf" "63","Tysabri","932","09/22/2016","2747","Helpful Information for Evaluation of New Neurologic Symptoms in Patient Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Helpful_Information_for_Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_MS.pdf" "63","Tysabri","932","09/22/2016","2748","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Understanding_PML_for_Gastroenterologists_CD.pdf" "63","Tysabri","932","09/22/2016","2749","TOUCH On-Line REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_REMS_Website_Screenshots .pdf" "63","Tysabri","932","09/22/2016","2750","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Change_Prescriber_Authorization_Form .pdf" "63","Tysabri","932","09/22/2016","2751","12-Week Questionnaire for Crohn's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016_09-22_12_Week_Questionnaire_For_Crohns_Disease .pdf" "63","Tysabri","932","09/22/2016","2752","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Patient_Status_Report_and_Reauthorization_Questionnaire_MS .pdf" "63","Tysabri","932","09/22/2016","2753","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Patient_Status_Report_and_Reauthorization_Questionnaire_CD .pdf" "63","Tysabri","932","09/22/2016","2754","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Initial_ Discontinuation_Questionnaire_MS .pdf" "63","Tysabri","932","09/22/2016","2755","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Initial_Discontinuation_Questionnaire_CD .pdf" "63","Tysabri","932","09/22/2016","2756","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_6_Month_Discontinuation_Questionnaire_MS .pdf" "63","Tysabri","932","09/22/2016","2757","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_6_Month_Discontinuation_Questionnaire_ CD .pdf" "63","Tysabri","932","09/22/2016","2759","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Certified_Pharmacy_Enrollment_Form .pdf" "63","Tysabri","932","09/22/2016","2760","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Infusion_Site_Enrollment_Form .pdf" "63","Tysabri","932","09/22/2016","2761","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Prescriber_Patient_Enrollment_Form_MS .pdf" "63","Tysabri","932","09/22/2016","2762","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-09-22_Prescriber_Patient_Enrollment_Form_CD.pdf" "2","Adasuve","933","09/28/2016","2763","Healthcare Facility Enrollment Information and Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Healthcare_Facility_Enrollment_Information_and_Form .pdf" "2","Adasuve","933","09/28/2016","2764","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Healthcare_Provider_Brochure .pdf" "2","Adasuve","933","09/28/2016","2765","Steps for Safe Use of Adasuve","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Steps_for_Safe_Use_of_Adasuve .pdf" "2","Adasuve","933","09/28/2016","2766","Order Set/Protocol Template","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Order_Set_Protocol_Template .pdf" "2","Adasuve","933","09/28/2016","2767","Adasuve Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Education_Program .pdf" "2","Adasuve","933","09/28/2016","2768","Adasuve REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_REMS_Website_Screenshots .pdf" "2","Adasuve","933","09/28/2016","2769","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_REMS_Document .pdf" "2","Adasuve","933","09/28/2016","2770","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-09-28_Full.pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2771","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Patient_Counseling_Document .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2772","FDA Blueprint for Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_FDA_Blueprint_for_Prescriber_Education_for_Extended_Release_and_Long_Acting_Opioid_Analgesics .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2773","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Prescriber_Letter_1 .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2774","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Prescriber_Letter_2 .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2775","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Prescriber_Letter_3 .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2776","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Professional_Organization_Licensing_Board_Letter_1 .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2777","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Professional_Organization_Licensing_Board_Letter_2 .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2778","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_REMS_Website_Screenshots .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2779","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_REMS_Document .pdf" "17","Opioid Analgesic REMS","934","09/30/2016","2780","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2016-09-30_Full.pdf" "343","Natpara","935","09/29/2016","2782","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_An_Introduction .pdf" "343","Natpara","935","09/29/2016","2783","Training Module for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09_29_Training_Module_for_Prescribers .pdf" "343","Natpara","935","09/29/2016","2784","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Prescriber_Enrollment_Form.pdf" "343","Natpara","935","09/29/2016","2785","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Patient_Brochure .pdf" "343","Natpara","935","09/29/2016","2786","Patient-Prescriber Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Patient_Prescriber_Acknowledgment_Form .pdf" "343","Natpara","935","09/29/2016","2787","Training Module for Pharmacy Representatives","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Training_Module_for_Pharmacy_Representatives.pdf" "343","Natpara","935","09/29/2016","2788","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Pharmacy_Enrollment_Form .pdf" "343","Natpara","935","09/29/2016","2789","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016_09-29_Full.pdf" "343","Natpara","935","09/29/2016","2790","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016_09-29_REMS_Document .pdf" "343","Natpara","935","09/29/2016","2791","Frequently Asked Questions (FAQ)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_Frequently_Asked_Questions .pdf" "343","Natpara","935","09/29/2016","2792","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2016-09-29_REMS_Website_Screenshots .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2793","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2794","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Dear_Pharmacist_Letter .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2795","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Appropriate_Use_Checklist .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2796","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Important_Information_for_Prescribers .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2797","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Important_Information_for_Pharmacists .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2798","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_REMS_Website_Screenshots .pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2799","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","2800","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2016-10-04_REMS_Document .pdf" "149","Adempas","937","10/04/2016","2801","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Prescriber_Enrollment_and_Agreement_Form.pdf" "149","Adempas","937","10/04/2016","2802","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Prescriber_and_Pharmacy_Guide.pdf" "149","Adempas","937","10/04/2016","2803","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "149","Adempas","937","10/04/2016","2804","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Patient_Enrollment_and_Consent_Form.pdf" "149","Adempas","937","10/04/2016","2805","Change in Reproductive Potential Status and Prepubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Change_in_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "149","Adempas","937","10/04/2016","2806","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_REMS_Website_Screenshots.pdf" "149","Adempas","937","10/04/2016","2807","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Inpatient_Pharmacy_Enrollment_Form.pdf" "149","Adempas","937","10/04/2016","2808","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_REMS_Document .pdf" "149","Adempas","937","10/04/2016","2809","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2016-10-04_Full.pdf" "354","Bupropion (ANDA 206122)","938","08/17/2016","2810","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bupropion_(ANDA_206122)_2016-08-17_REMS_Document .pdf" "63","Tysabri","939","10/14/2016","2811","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Prescribing_Program_Educational_Slide_Set .pdf" "63","Tysabri","939","10/14/2016","2812","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Prescribing_Program_Overview.pdf" "63","Tysabri","939","10/14/2016","2813","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Prescriber_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","939","10/14/2016","2814","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Presciber_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","939","10/14/2016","2815","Pre-Infusion Patient Checklist (combined MS and CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Pre_Infusion_Patient_Checklist.pdf" "63","Tysabri","939","10/14/2016","2816","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Understanding_PML_Gastroenterologists_CD.pdf" "63","Tysabri","939","10/14/2016","2817","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Change_Prescriber_Authorization_Form.pdf" "63","Tysabri","939","10/14/2016","2818","12 Week Questionnaire for Crohn's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_12_Week_Questionnaire_for_Crohns_Disease.pdf" "63","Tysabri","939","10/14/2016","2819","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Patient_Status_Report_and_Reauthorization_Questionnaire_MS.pdf" "63","Tysabri","939","10/14/2016","2820","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Patient_Status_Report_and_Reauthorization_Questionnaire_Crohn's_Disease.pdf" "63","Tysabri","939","10/14/2016","2821","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Initial_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","939","10/14/2016","2822","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Initial_Discontinuation_Questionnaire_Crohns_Disease.pdf" "63","Tysabri","939","10/14/2016","2823","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_6_Month_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","939","10/14/2016","2824","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_6_Month_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","939","10/14/2016","2825","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Certified_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","939","10/14/2016","2826","TOUCH On-Line REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_REMS_Website_Screenshots.pdf" "63","Tysabri","939","10/14/2016","2827","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Helpful_Information_for_Evaluation_of_New_Neurological_Symptoms_in_Patients_Receiving_Tysabri_MS .pdf" "63","Tysabri","939","10/14/2016","2828","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14-2016_Full.pdf" "63","Tysabri","939","10/14/2016","2829","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_REMS_Document .pdf" "63","Tysabri","939","10/14/2016","2830","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2016-10-14_Infusion_Site_Enrollment_Form.pdf" "18","Extraneal","940","10/24/2016","2831","PD Nurse Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016_10-24_PD_Nurse_Training_Tool.pdf" "18","Extraneal","940","10/24/2016","2832","Patient Training Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Patient_Training_Tool.pdf" "18","Extraneal","940","10/24/2016","2833","Patient Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Patient_Kit .pdf" "18","Extraneal","940","10/24/2016","2834","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_REMS_Document.pdf" "18","Extraneal","940","10/24/2016","2835","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Full.pdf" "2","Adasuve","941","10/19/2016","2836","Healthcare Facility Enrollment Information and Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Healthcare_Facility_Enrollment_Information_and_Form.pdf" "2","Adasuve","941","10/19/2016","2837","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Healthcare_Provider_Brochure.pdf" "2","Adasuve","941","10/19/2016","2838","Steps for Safe Use","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Steps_for_Safe_Use_of_Adasuve.pdf" "2","Adasuve","941","10/19/2016","2839","Order Set/Protocol Template","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Order_Set_Protocol_Template.pdf" "2","Adasuve","941","10/19/2016","2840","Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Education_Program.pdf" "2","Adasuve","941","10/19/2016","2841","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_REMS_Website_Screenshots .pdf" "2","Adasuve","941","10/19/2016","2842","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_REMS_Document .pdf" "2","Adasuve","941","10/19/2016","2843","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2016-10-19_Full.pdf" "314","Myalept","942","11/07/2016","2844","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_Prescriber_Training_Module .pdf" "314","Myalept","942","11/07/2016","2845","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_Prescriber_Enrollment_Form.pdf" "314","Myalept","942","11/07/2016","2846","MYALEPT REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_REMS_Program_An_Introduction .pdf" "314","Myalept","942","11/07/2016","2847","REMS Program website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_REMS_Website_Screenshot.pdf" "314","Myalept","942","11/07/2016","2848","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_Prescription_Authorization_Form .pdf" "314","Myalept","942","11/07/2016","2849","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_REMS_Document .pdf" "314","Myalept","942","11/07/2016","2850","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-07_Full.pdf" "358","Xultophy","927","11/21/2016","2851","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_REMS_Document.pdf" "358","Xultophy","927","11/21/2016","2852","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_Full.pdf" "358","Xultophy","927","11/21/2016","2853","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_Letter_for_Healthcare_Providers.pdf" "358","Xultophy","927","11/21/2016","2854","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_Letter_for_Professional_Societies.pdf" "358","Xultophy","927","11/21/2016","2855","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_REMS_Factsheet.pdf" "358","Xultophy","927","11/21/2016","2856","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_REMS_Slides.pdf" "358","Xultophy","927","11/21/2016","2857","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xultophy_2016-11-21_REMS_Website_Screenshot_(Landing_Page).pdf" "71","Xiaflex","943","11/28/2016","2859","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_REMS_Document.pdf" "71","Xiaflex","943","11/28/2016","2860","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Full.pdf" "71","Xiaflex","943","11/28/2016","2861","REMS Training Guide for Administering XIAFLEX for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Training_Guide.pdf" "71","Xiaflex","943","11/28/2016","2862","Healthcare Provider Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Healthcare_Provider_Enrollment_Form.pdf" "71","Xiaflex","943","11/28/2016","2863","Patient Counseling Tool, What You Need to Know About XIAFLEX Treatment for Peyronie’s disease: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Patient_Guide.pdf" "71","Xiaflex","943","11/28/2016","2864","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_REMS_Website_Screenshot_Landing_Page.pdf" "71","Xiaflex","943","11/28/2016","2865","Pharmacy/Healthcare Setting Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Pharmacy_Healthcare_Setting_Enrollment_Form.pdf" "71","Xiaflex","943","11/28/2016","2866","REMS Training Video for Administering XIAFLEX for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2016-11-28_Training_Video.pdf" "186","Iclusig","944","11/28/2016","2867","REMS Letter to Healthcare Providers (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Letter_to_Healthcare_Providers.pdf" "186","Iclusig","944","11/28/2016","2868","REMS Letter for Professional Societies (print version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Letter_for_Professional_Societies.pdf" "186","Iclusig","944","11/28/2016","2869","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Fact_Sheet.pdf" "186","Iclusig","944","11/28/2016","2870","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_REMS_Website_Screenshot.pdf" "186","Iclusig","944","11/28/2016","2871","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_REMS_Document.pdf" "186","Iclusig","944","11/28/2016","2872","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2016-11-28_Full.pdf" "314","Myalept","946","11/28/2016","2873","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_REMS_document.pdf" "314","Myalept","946","11/28/2016","2874","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_REMS_full.pdf" "314","Myalept","946","11/28/2016","2875","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_Prescriber_Training.pdf" "314","Myalept","946","11/28/2016","2876","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_Prescriber_Enrollment.pdf" "314","Myalept","946","11/28/2016","2877","MYALEPT REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_Introduction.pdf" "314","Myalept","946","11/28/2016","2878","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_REMS_website.pdf" "314","Myalept","946","11/28/2016","2879","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2016-11-28_Prescription_Auth_Form.pdf" "313","Aveed","948","12/09/2016","2880","Education Program for Healthcare Providers (with Knowledge Assessment)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Education_Program_for_Healthcare_Providers_with_Knowledge_Assessment.pdf" "313","Aveed","948","12/09/2016","2881","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Healthcare_Provider_Enrollment_Form.pdf" "313","Aveed","948","12/09/2016","2882","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Program_An_Introduction.pdf" "313","Aveed","948","12/09/2016","2883","What You Need to Know About Aveed Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.pdf" "313","Aveed","948","12/09/2016","2889","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Website_Screenshots.pdf" "313","Aveed","948","12/09/2016","2890","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Education_Program_for_Healthcare_Settings.pdf" "313","Aveed","948","12/09/2016","2891","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Healthcare_Setting_Enrollment_Form.pdf" "313","Aveed","948","12/09/2016","2892","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Full.pdf" "313","Aveed","948","12/09/2016","2893","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Document.pdf" "28","Letairis","949","12/15/2016","2894","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Prescriber_Enrollment_and_Agreement_Form.pdf" "28","Letairis","949","12/15/2016","2895","Prescriber Guide for the Letairis REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Prescriber_Guide.pdf" "28","Letairis","949","12/15/2016","2896","Letairis REMS Program Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Program_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "28","Letairis","949","12/15/2016","2897","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Patient_Enrollment_and_Consent_Form.pdf" "28","Letairis","949","12/15/2016","2898","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Change_In_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "28","Letairis","949","12/15/2016","2899","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_REMS_Website_Screenshots.pdf" "28","Letairis","949","12/15/2016","2900","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_Full.pdf" "28","Letairis","949","12/15/2016","2901","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2016-12-15_REMS_Document.pdf" "61","Tracleer","951","12/16/2016","2902","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Prescriber_Enrollment_and_Agreement_Form.pdf" "61","Tracleer","951","12/16/2016","2903","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Patient_Enrollment_and_Consent_Form.pdf" "61","Tracleer","951","12/16/2016","2904","Patient Enrollment and Consent Form (VA USE ONLY)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Patient_Enrollment_and_Consent_Form_VA_Use_Only.pdf" "61","Tracleer","951","12/16/2016","2905","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Prescriber_and_Pharmacy_Guide_for_the_Tracleer_REMS_Program.pdf" "61","Tracleer","951","12/16/2016","2906","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_REMS_Guide_for_Patients.pdf" "61","Tracleer","951","12/16/2016","2907","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Change_in_Reproductive_Potential_Status_and_Pre_pubertal_Annual_Verification_Form.pdf" "61","Tracleer","951","12/16/2016","2908","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Dear_Healthcare_Provider_Letter.pdf" "61","Tracleer","951","12/16/2016","2909","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_REMS_Website_Screenshots.pdf" "61","Tracleer","951","12/16/2016","2910","Inpatient Pharmacy Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Inpatient_Pharmacy_Enrollment_Form.pdf" "61","Tracleer","951","12/16/2016","2911","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_Full.pdf" "61","Tracleer","951","12/16/2016","2912","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2016-12-16_REMS_Document.pdf" "25","Juxtapid","953","01/03/2017","2913","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","953","01/03/2017","2914","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017_01-03_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","953","01/03/2017","2915","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Fact_Sheet.pdf" "25","Juxtapid","953","01/03/2017","2916","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Patient_Guide.pdf" "25","Juxtapid","953","01/03/2017","2917","Patient-Prescriber Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Patient_Prescriber_Acknowledgment_Form.pdf" "25","Juxtapid","953","01/03/2017","2918","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Prescription_Authorization_Form.pdf" "25","Juxtapid","953","01/03/2017","2919","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","953","01/03/2017","2920","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_REMS_Website_Screenshots.pdf" "25","Juxtapid","953","01/03/2017","2921","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","953","01/03/2017","2922","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","953","01/03/2017","2923","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Letter_for_Pharmacists.pdf" "25","Juxtapid","953","01/03/2017","2924","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_Full.pdf" "25","Juxtapid","953","01/03/2017","2925","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-01-03_REMS_Document.pdf" "321","Zydelig","954","01/04/2017","2926","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Letter_to_Healthcare_Providers.pdf" "321","Zydelig","954","01/04/2017","2927","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Letter_for_Professional_Societies.pdf" "321","Zydelig","954","01/04/2017","2928","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Fact_Sheet.pdf" "321","Zydelig","954","01/04/2017","2929","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_REMS_Website_Screenshot.pdf" "321","Zydelig","954","01/04/2017","2930","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Patient_Safety_Information_Card.pdf" "321","Zydelig","954","01/04/2017","2931","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Full.pdf" "321","Zydelig","954","01/04/2017","2932","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_REMS_Document.pdf" "360","Alosetron","956","11/22/2016","2933","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_REMS_full.pdf" "360","Alosetron","956","11/22/2016","2934","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_REMS_document.pdf" "360","Alosetron","956","11/22/2016","2935","REMS letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_REMS_letter_Healthcare Providers.pdf" "360","Alosetron","956","11/22/2016","2936","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_Prescriber_Education_Slide_Deck.pdf" "360","Alosetron","956","11/22/2016","2937","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_Safety_Information_Fact_Sheet_prescribers.pdf" "360","Alosetron","956","11/22/2016","2938","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_Patient_Education_Sheet.pdf" "360","Alosetron","956","11/22/2016","2939","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_Prescriber_Completion_Training_Form.pdf" "360","Alosetron","956","11/22/2016","2940","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2016-11-22_REMS_website_screenshot.pdf" "49","Soliris","957","01/13/2017","2941","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Patient_Safety_Card.pdf" "49","Soliris","957","01/13/2017","2942","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Prescriber_Introductory_Letter_and_Enrollment_Form.pdf" "49","Soliris","957","01/13/2017","2943","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Patient_Safety_Brochure_Important_Safety_Information_For_Patients.pdf" "49","Soliris","957","01/13/2017","2944","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Prescriber_Safety_Brochure_Important_Safety_Information_For_the_Healthcare_Provider.pdf" "49","Soliris","957","01/13/2017","2945","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Dosing_And_Administration_Guide.pdf" "49","Soliris","957","01/13/2017","2946","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_REMS_Website_Screenshot.pdf" "49","Soliris","957","01/13/2017","2947","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Full.pdf" "49","Soliris","957","01/13/2017","2948","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_REMS_Document.pdf" "149","Adempas","958","01/17/2017","2949","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Prescriber_Enrollment_and_Agreement_Form.pdf" "149","Adempas","958","01/17/2017","2950","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Prescriber_and_Pharmacy_Guide.pdf" "149","Adempas","958","01/17/2017","2951","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "149","Adempas","958","01/17/2017","2952","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Patient_Enrollment_and_Consent_Form.pdf" "149","Adempas","958","01/17/2017","2953","Change in Reproductive Potential Status and Prepubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Change_in_Reproductive_Potential_Status_and_Pre_pubertal_Annual_Verification_Form.pdf" "149","Adempas","958","01/17/2017","2954","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_REMS_Website_Screenshots.pdf" "149","Adempas","958","01/17/2017","2955","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Full.pdf" "149","Adempas","958","01/17/2017","2956","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_REMS_Document.pdf" "149","Adempas","958","01/17/2017","2957","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Inpatient_Pharmacy_Enrollment_Form.pdf" "361","Sodium Oxybate","959","01/17/2017","2958","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescription_Form.pdf" "361","Sodium Oxybate","959","01/17/2017","2960","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescriber_Enrollment_Form.pdf" "361","Sodium Oxybate","959","01/17/2017","2961","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescriber_Brochure.pdf" "361","Sodium Oxybate","959","01/17/2017","2962","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Enrollment_Form.pdf" "361","Sodium Oxybate","959","01/17/2017","2963","Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Quick_Start_Guide.pdf" "361","Sodium Oxybate","959","01/17/2017","2964","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_REMS_Website_Screenshots.pdf" "361","Sodium Oxybate","959","01/17/2017","2965","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Certified_Pharmacy_Training_Program.pdf" "361","Sodium Oxybate","959","01/17/2017","2966","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Pharmacy_Enrollment_Form.pdf" "361","Sodium Oxybate","959","01/17/2017","2967","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Counseling_Checklist.pdf" "361","Sodium Oxybate","959","01/17/2017","2968","Risk Management Report Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Risk_Management_Report.pdf" "361","Sodium Oxybate","959","01/17/2017","2969","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium Oxybate_2017-01-17_Full.pdf" "361","Sodium Oxybate","959","01/17/2017","2970","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_REMS_Document.pdf" "7","Axiron","960","01/23/2017","2971","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2017-01-23_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2972","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2973","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2974","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2975","Prescriber Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Important_Information_for_Prescribers.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2976","Pharmacist Brochure, "Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Important_Information_for_Pharmacists.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2977","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_REMS_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2978","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","2979","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-01-23_REMS_Document.pdf" "341","Blincyto","962","01/30/2017","2980","Letter for Healthcare Providers (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-01-30_Letter_for_Healthcare_Providers_(email_and_print_versions).pdf" "341","Blincyto","962","01/30/2017","2981","Letter for Hospital and Home Healthcare Pharmacists (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-01-30_Letter_for_Hospital_and_Home_Healthcare_Pharmacists_(email_and_print_versions).pdf" "341","Blincyto","962","01/30/2017","2982","Letter for Professional Societies (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blinctyo_2017-01-30_Letter_for_Professional_Societies_(email_and_print_versions).pdf" "341","Blincyto","962","01/30/2017","2983","Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-01-30_Fact_Sheet_for_Healthcare_Providers.pdf" "341","Blincyto","962","01/30/2017","2984","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blinctyo_2017-01-30_REMS_Website_Screenshot.pdf" "341","Blincyto","962","01/30/2017","2985","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blinctyo_2017-01-30_Full.pdf" "341","Blincyto","962","01/30/2017","2986","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-01-30_REMS_Document .pdf" "71","Xiaflex","963","01/25/2017","2987","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_REMS_full.pdf" "71","Xiaflex","963","01/25/2017","2988","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_REMS_document.pdf" "71","Xiaflex","963","01/25/2017","2989","Patient Counseling Tool, What You Need to Know About XIAFLEX Treatment for Peyronie’s disease: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_Patient_Counseling_Tool.pdf" "71","Xiaflex","963","01/25/2017","2990","REMS Training Guide for Administering XIAFLEX for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_Training_Guide.pdf" "71","Xiaflex","963","01/25/2017","2991","Healthcare Provider Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_HCP_Enrollment_Form.pdf" "71","Xiaflex","963","01/25/2017","2992","Pharmacy/Healthcare Setting Enrollment Form for Peyronie’s disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_Pharmacy_Enrollment_Form .pdf" "71","Xiaflex","963","01/25/2017","2993","REMS Training Video for Administering XIAFLEX for Peyronie’s disease (accessed at www.XIAFLEXREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_video_transcript.pdf" "71","Xiaflex","963","01/25/2017","2994","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2017-01-25_website_screenshot.pdf" "7","Axiron","964","02/03/2017","2995","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2017-02-03_REMS_document.pdf" "362","Siliq","965","02/15/2017","2996","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Prescriber_Enrollment_Form.pdf" "362","Siliq","965","02/15/2017","2997","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Patient_Prescriber_Agreement_Form.pdf" "362","Siliq","965","02/15/2017","2998","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Patient_Wallet_Card.pdf" "362","Siliq","965","02/15/2017","2999","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Pharmacy_Enrollment_Forrm.pdf" "362","Siliq","965","02/15/2017","3000","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_REMS_Website_Screenshots.pdf" "362","Siliq","965","02/15/2017","3001","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_REMS_Document.pdf" "362","Siliq","965","02/15/2017","3002","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Full.pdf" "46","Revlimid","966","02/22/2017","3003","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Guide.pdf" "46","Revlimid","966","02/22/2017","3004","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "46","Revlimid","966","02/22/2017","3005","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Celgene_REMS_Programs_Pharmacy_Training.pdf" "46","Revlimid","966","02/22/2017","3006","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","966","02/22/2017","3007","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Physician_Agreement_Form_for_Adult_Male.pdf" "46","Revlimid","966","02/22/2017","3008","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Physician_Agreement_Form_for_Male_Child.pdf" "46","Revlimid","966","02/22/2017","3009","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Prescriber_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","966","02/22/2017","3010","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","966","02/22/2017","3011","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","966","02/22/2017","3012","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","966","02/22/2017","3013","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Pharmacy_Guide.pdf" "46","Revlimid","966","02/22/2017","3014","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Emergency_Contraception_Brochure.pdf" "46","Revlimid","966","02/22/2017","3015","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","966","02/22/2017","3016","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","966","02/22/2017","3017","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","966","02/22/2017","3018","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Prescriber_Enrollment_Form.pdf" "46","Revlimid","966","02/22/2017","3019","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Prescription_Form.pdf" "46","Revlimid","966","02/22/2017","3020","Patient Prescription Form (VA Only)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Patient_Prescription_Form_VA_Only.pdf" "46","Revlimid","966","02/22/2017","3021","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Prescriber_Guide.pdf" "46","Revlimid","966","02/22/2017","3022","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Revlimid_At_A_Glance.pdf" "46","Revlimid","966","02/22/2017","3023","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Welcome_Letter.pdf" "46","Revlimid","966","02/22/2017","3024","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Celgene_Risk_Management_Website_Screenshots.pdf" "46","Revlimid","966","02/22/2017","3025","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_Full.pdf" "46","Revlimid","966","02/22/2017","3026","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-02-22_REMS_Document.pdf" "363","testosterone (ANDA 204255)","967","02/28/2017","3027","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_(ANDA_204255)_2017-02-28 _Full.pdf" "363","testosterone (ANDA 204255)","967","02/28/2017","3029","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_(ANDA_204255)_2017-02-28_REMS_Document.pdf" "25","Juxtapid","968","03/02/2017","3031","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","968","03/02/2017","3032","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","968","03/02/2017","3033","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Fact_Sheet.pdf" "25","Juxtapid","968","03/02/2017","3034","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Patient_Guide.pdf" "25","Juxtapid","968","03/02/2017","3035","Patient-Prescriber Acknowledgment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","968","03/02/2017","3036","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Prescription_Authorization_Form.pdf" "25","Juxtapid","968","03/02/2017","3037","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","968","03/02/2017","3038","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_REMS_Website_Screenshots.pdf" "25","Juxtapid","968","03/02/2017","3039","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Pharmacy_Training_and_Knowledge_Assessment.pdf" "25","Juxtapid","968","03/02/2017","3040","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","968","03/02/2017","3041","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Letter_for_Pharmacists.pdf" "25","Juxtapid","968","03/02/2017","3042","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_Full.pdf" "25","Juxtapid","968","03/02/2017","3043","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2017-03-02_REMS_Document.pdf" "357","Zinbryta","969","03/10/2017","3044","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_REMS_Document.pdf" "357","Zinbryta","969","03/10/2017","3045","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Letter_for_Healthcare_Providers.pdf" "357","Zinbryta","969","03/10/2017","3046","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Program_Overview.pdf" "357","Zinbryta","969","03/10/2017","3047","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbrtya_2017-03-10_Prescriber_Training.pdf" "357","Zinbryta","969","03/10/2017","3048","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Prescriber_Enrollment_Form.pdf" "357","Zinbryta","969","03/10/2017","3049","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Prescriber_Knowledge_Assessment.pdf" "357","Zinbryta","969","03/10/2017","3050","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Patient_Enrollment_Form.pdf" "357","Zinbryta","969","03/10/2017","3051","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Patient_Status_Form.pdf" "357","Zinbryta","969","03/10/2017","3052","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Patient_Guide.pdf" "357","Zinbryta","969","03/10/2017","3053","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Patient_Wallet_Card.pdf" "357","Zinbryta","969","03/10/2017","3054","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Pharmacy_Enrollment_Form.pdf" "357","Zinbryta","969","03/10/2017","3055","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_REMS_Website_Screenshots.pdf" "357","Zinbryta","969","03/10/2017","3056","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017-03-10_Full.pdf" "21","Gattex","970","03/21/2017","3057","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","970","03/21/2017","3058","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","970","03/21/2017","3059","What You Need to Know About Gattex Treatment: A Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_What_You_Need_to_Know_About_Gattex_Treatment_A_Patient_Caregiver_Counseling_Guide.pdf" "21","Gattex","970","03/21/2017","3060","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_REMS_Website_Screenshots.pdf" "21","Gattex","970","03/21/2017","3061","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_REMS_Full.pdf" "21","Gattex","970","03/21/2017","3062","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2017-03-21_REMS_Document.pdf" "76","Opsumit","971","03/21/2017","3063","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","971","03/21/2017","3064","Patient Enrollment and Consent Form - for VA use only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Patient_Enrollment_and_Consent_Form_VA_Use_Only.pdf" "76","Opsumit","971","03/21/2017","3065","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "76","Opsumit","971","03/21/2017","3066","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","971","03/21/2017","3067","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","971","03/21/2017","3068","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Change_in_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "76","Opsumit","971","03/21/2017","3069","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_REMS_Website_Screenshots.pdf" "76","Opsumit","971","03/21/2017","3070","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","971","03/21/2017","3071","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_REMS_Document.pdf" "76","Opsumit","971","03/21/2017","3072","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017-03-21_REMS_full.pdf" "346","Ionsys","973","03/29/2017","3073","Safety Brochure: Guide for Nurses and Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_Safety_Brochure_Guide_for_Nurses_and_Pharmacists.pdf" "346","Ionsys","973","03/29/2017","3074","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_Knowledge_Assessment.pdf" "346","Ionsys","973","03/29/2017","3075","Dear Healthcare Provider Letters","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_Dear_Healthcare_Provider_Letters.pdf" "346","Ionsys","973","03/29/2017","3076","Dear Hospital Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_Dear_Director_of_Hospital_Pharmacy.pdf" "346","Ionsys","973","03/29/2017","3077","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_Hospital_Enrollment_Form.pdf" "346","Ionsys","973","03/29/2017","3078","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_REMS_Document.pdf" "346","Ionsys","973","03/29/2017","3079","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_REMS_Full.pdf" "346","Ionsys","973","03/29/2017","3080","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2017-03-29_REMS_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3081","Prescriber Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Prescriber_Program_Overview.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3082","Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Education_Program_for_Prescribers_and_Pharmacists.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3083","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3084","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3085","Patient Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Patient_Prescriber_Agreement_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3086","Patient and Caregiver Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_An_Overview_for_Patients_and_Caregivers.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3087","Frequently Asked Questions (FAQs)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Frequently_Asked_Questions.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3088","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_REMS_Website_Screenshot.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3089","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3090","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3091","Program Overview (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_An_Overview_for_Independent_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3092","Program Overview (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_An_Overview_for_Chain_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3093","Program Overview (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_An_Overview_for_Closed_System_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3094","Pharmacy Enrollment Form (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Independent_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3095","Pharmacy Enrollment Form (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Chain_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3096","Pharmacy Enrollment Form (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Closed_System_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3097","Pharmacy Enrollment Form (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3098","Dear Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Dear_Distributor_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3099","Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Distributor_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3100","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Dear_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3101","Dear Pharmacy Letter (Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Dear_Pharmacy_Letter_Outpatient.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3102","Dear Pharmacy Letter (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_Dear_Pharmacy_Letter_Inpatient.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","3103","Program Overview (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-04-11_An_Overview_for_Inpatient_Pharmacies.pdf" "356","Probuphine","979","04/19/2017","3104","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Healthcare_Provider_Who_Prescribes_Enrollment_Form.pdf" "356","Probuphine","979","04/19/2017","3105","What You Need to Know About Probuphine: A Patient's Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_What_You_Need_to_Know_About_Probuphine_A_Patients_Guide.pdf" "356","Probuphine","979","04/19/2017","3106","Slides for Live Training: Lecture and Practicum","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Slides_for_Live_Training_Lecture_and_Practicum.pdf" "356","Probuphine","979","04/19/2017","3107","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Knowledge_Assessment.pdf" "356","Probuphine","979","04/19/2017","3108","Insertion/Removal Log","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Insertion_Removal_Log.pdf" "356","Probuphine","979","04/19/2017","3109","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_REMS_Website_Screenshots.pdf" "356","Probuphine","979","04/19/2017","3110","Healthcare Provider Who Performs Probuphine Surgical Procedures Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Healthcare_Provider_Who_Performs_Probuphine_Surgical_Procedures_Enrollment_Form.pdf" "356","Probuphine","979","04/19/2017","3111","Healthcare Provider Dual Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Healthcare_Provider_Dual_Enrollment_Form.pdf" "356","Probuphine","979","04/19/2017","3112","Criteria for Procedural Competency","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Criteria_for_Procedural_Competency.pdf" "356","Probuphine","979","04/19/2017","3113","Procedure Record for Recertification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Procedure_Record_for_Recertification.pdf" "356","Probuphine","979","04/19/2017","3114","Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Healthcare_Provider_Who_Performs_Probuphine_Surgical_Procedures_Recertification_Form.pdf" "356","Probuphine","979","04/19/2017","3115","Surgical Procedures Recertification Video Transcript","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Surgical_Procedures_Recertification_Video_Transcript.pdf" "356","Probuphine","979","04/19/2017","3116","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_REMS_Document.pdf" "356","Probuphine","979","04/19/2017","3117","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2017-04-19_Full.pdf" "62","Truvada","980","04/21/2017","3118","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Dear_Healthcare_Provider_Letter.pdf" "62","Truvada","980","04/21/2017","3119","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Training_Guide_for_Healthcare_Providers.pdf" "62","Truvada","980","04/21/2017","3120","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Healthcare_Provider_Education_Slide_Deck.pdf" "62","Truvada","980","04/21/2017","3121","Important Safety Information about TRUVADA for a PrEP Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Important_Safety_Information_About_Truvada_for_a_Pre_exposure_Prophylaxis_PrEP_Indication_for_Healthcare_Providers.pdf" "62","Truvada","980","04/21/2017","3122","Important Safety Information about TRUVADA to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Important_Safety_Information_About_Truvada_to_Reduce_the_Risk_of_Getting_Human_Immunodeficiency_Virus_1_(HIV-1)_Infection.pdf" "62","Truvada","980","04/21/2017","3123","Agreement Form for Initiating TRUVADA for Pre-Exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Agreement_Form_for_Initiating_Truvada_for_Pre_exposure_Prophylaxis_PrEP.pdf" "62","Truvada","980","04/21/2017","3124","Checklist for Prescribers: Initiation of TRUVADA for Pre-exposure Prophylaxis (PrEP) to manage an uninfected individual considering or taking TRUVADA for a PrEP indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Checklist_for_Prescribers_Initiation_of_Truvada_for_Pre-exposure_Prophylaxis_PrEP.pdf" "62","Truvada","980","04/21/2017","3125","Safety Information Fact Sheet for Prescribers about TRUVADA for a Pre-exposure Prophylaxis (PrEP) Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Safety_Information_Fact_Sheet_for_Prescribers_about_Truvada_for_a_Pre_Exposure_Prophylaxis_PrEP_Indication.pdf" "62","Truvada","980","04/21/2017","3126","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Full.pdf" "62","Truvada","980","04/21/2017","3127","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_REMS_Document.pdf" "62","Truvada","980","04/21/2017","3128","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_REMS_Website_Screenshots .pdf" "62","Truvada","980","04/21/2017","3129","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Truvada_2017-04-21_Important_Information_for_Prescribers_About_Truvada_for_a_Pre_exposure_Prophylaxis_PrEP_Indication.pdf" "364","Vigabatrin","983","04/27/2017","3130","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-17_Full.pdf" "364","Vigabatrin","983","04/27/2017","3131","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_REMS_Document .pdf" "364","Vigabatrin","983","04/27/2017","3132","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "364","Vigabatrin","983","04/27/2017","3133","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","983","04/27/2017","3134","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_Prescriber_Enrollment_and_Agreement_Form.pdf" "364","Vigabatrin","983","04/27/2017","3135","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_REMS_Website_Screenshots.pdf" "364","Vigabatrin","983","04/27/2017","3136","What You Need to Know About Vigabatrin Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-04-27_What_You_Need_to_Know_About_Vigabatrin_Treatment_A_Patient_Guide.pdf" "322","Trulicity","984","04/19/2017","3137","REMS Letter for Healthcare Providers (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Letter_for_Healthcare_Providers_Print_Version.pdf" "322","Trulicity","984","04/19/2017","3138","REMS Letter for Professional Societies (Print Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Letter_for_Professional_Societies_Print_Version.pdf" "322","Trulicity","984","04/19/2017","3139","REMS Letter for Healthcare Providers (Email Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Letter_for_Healthcare_Providers_Email_Version.pdf" "322","Trulicity","984","04/19/2017","3140","REMS Letter for Professional Societies (Email Version)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Letter_for_Professional_Societies_Email_Version.pdf" "322","Trulicity","984","04/19/2017","3141","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Factsheet.pdf" "322","Trulicity","984","04/19/2017","3142","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Document.pdf" "322","Trulicity","984","04/19/2017","3143","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_Full.pdf" "322","Trulicity","984","04/19/2017","3144","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Trulicity_2017-04-19_REMS_Website_Screenshot.pdf" "11","Caprelsa","988","05/16/2017","3145","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_REMS_Website_Screenshots.pdf" "11","Caprelsa","988","05/16/2017","3146","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_REMS_Document.pdf" "11","Caprelsa","988","05/16/2017","3147","Prescriber Training Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Prescriber_Training_Slide_Deck.pdf" "11","Caprelsa","988","05/16/2017","3148","Prescriber Training Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Prescriber_Training_Questions.pdf" "11","Caprelsa","988","05/16/2017","3149","Prescriber Training Pamphlet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Prescriber_Training_Pamphlet.pdf" "11","Caprelsa","988","05/16/2017","3150","Prescriber Enrollment Form Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Prescriber_Enrollment_Form_Screenshots.pdf" "11","Caprelsa","988","05/16/2017","3151","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Pharmacy_Enrollment_Form.pdf" "11","Caprelsa","988","05/16/2017","3152","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Patient_Brochure.pdf" "11","Caprelsa","988","05/16/2017","3153","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2017-05-16_Full.pdf" "342","Saxenda","989","05/22/2017","3154","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Letter_for_Healthcare_Providers.pdf" "342","Saxenda","989","05/22/2017","3155","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Letter_for_Professional_Societies.pdf" "342","Saxenda","989","05/22/2017","3156","REMS Factsheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Factsheet.pdf" "342","Saxenda","989","05/22/2017","3157","REMS Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Slides.pdf" "342","Saxenda","989","05/22/2017","3158","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Website_Screenshot.pdf" "342","Saxenda","989","05/22/2017","3159","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_Full.pdf" "342","Saxenda","989","05/22/2017","3160","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Document.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3161","Patient Counseling Document (PCD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Patient_Counseling_Document_PCD.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3163","Prescriber Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_1.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3164","Prescriber Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_2.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3165","Prescriber Letter 3","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Prescriber_Letter_3.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3166","Professional Organization/Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Professional_Organization_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3167","Professional Organization/Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Professional_Organization_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3168","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_REMS_Website_Screenshots.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3170","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_Full.pdf" "17","Opioid Analgesic REMS","991","05/26/2017","3171","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/ERLA_2017-05-26_REMS_Document.pdf" "364","Vigabatrin","993","05/24/2017","3179","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_REMS_full.pdf" "364","Vigabatrin","993","05/24/2017","3180","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_REMS_document.pdf" "364","Vigabatrin","993","05/24/2017","3181","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_Prescriber_Enrollment_Agreement_Form.pdf" "364","Vigabatrin","993","05/24/2017","3182","What You Need to Know About Vigabatrin Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_Patient_Guide .pdf" "364","Vigabatrin","993","05/24/2017","3183","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_Patient_Physician_Agreement_Form.pdf" "364","Vigabatrin","993","05/24/2017","3184","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_Prescriber_Enrollment_Agreement_Form.pdf" "364","Vigabatrin","993","05/24/2017","3185","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","993","05/24/2017","3186","REMS Program Website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-05-24_REMS_Program_Website.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3187","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_REMS_full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3188","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_REMS_document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3189","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3190","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3191","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3192","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_Prescriber_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3193","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_Pharmacist_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","3194","BTOD REMS Website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2017-05-23_BTOD_REMS_Website.pdf" "362","Siliq","995","06/08/2017","3195","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_Prescriber_Enrollment_Form.pdf" "362","Siliq","995","06/08/2017","3196","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_Patient_Prescriber_Agreement_Form.pdf" "362","Siliq","995","06/08/2017","3197","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_Patient_Wallet_Card.pdf" "362","Siliq","995","06/08/2017","3198","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_Pharmacy_Enrollment_Form.pdf" "362","Siliq","995","06/08/2017","3199","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_REMS_Website_Screenshots.pdf" "362","Siliq","995","06/08/2017","3200","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_Full.pdf" "362","Siliq","995","06/08/2017","3201","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-06-08_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3202","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Dear_Healthcare_Provider_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3203","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08__Training_Guide_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3204","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Healthcare_Provider_Education_Slide_Deck.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3205","Important Safety Information about emtricitabine/tenofovir disoproxil fumarate for a PrEP Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Important_Safety_Information_about_emtricitabine_tenofovir_disoproxil_fumarate_for_a_PrEP_Indication_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3206","Important Safety Information about emtricitabine/tenofovir disoproxil fumarate to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Important_Safety_Information_about_emtricitabine_tenofovir_disoproxil_fumarate_to_Reduce_the_Risk_of_Getting_Human_Immunodeficiency_Virus_1_HIV_1_Infection.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3207","Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Agreement_Form.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3208","Checklist for Prescribers: Initiation of emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis (PrEP) to manage an uninfected individual considering or taking emtricitabine/tenofovir disoproxil fumarate for a PrEP indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Checklist_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3209","Safety Information Fact Sheet for Prescribers about emtricitabine/tenofovir disoproxil fumarate for a Pre-exposure Prophylaxis (PrEP) Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Safety-Information_Fact_Sheet_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3210","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3211","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","3212","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-06-08_REMS_Website_Screenshots.pdf" "58","Thalomid","998","06/09/2017","3213","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Prescriber_Enrollment_Form.pdf" "58","Thalomid","998","06/09/2017","3214","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Patient_Prescription_Form.pdf" "58","Thalomid","998","06/09/2017","3215","Patient Prescription Form (Veterans Health Adminstration)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Patient_Prescription_Form_VHA_Only.pdf" "58","Thalomid","998","06/09/2017","3216","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Prescriber_Guide.pdf" "58","Thalomid","998","06/09/2017","3217","Thalomid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_At_A_Glance.pdf" "58","Thalomid","998","06/09/2017","3218","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Welcome_Letter.pdf" "58","Thalomid","998","06/09/2017","3219","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Celgene_Risk_Management_Website_Screenshots.pdf" "58","Thalomid","998","06/09/2017","3220","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Pharmacy_Guide.pdf" "58","Thalomid","998","06/09/2017","3221","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "58","Thalomid","998","06/09/2017","3222","Celgene REMS Programs Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","998","06/09/2017","3223","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","998","06/09/2017","3224","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Adult_Male.pdf" "58","Thalomid","998","06/09/2017","3225","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Male_Child.pdf" "58","Thalomid","998","06/09/2017","3226","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","998","06/09/2017","3227","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","998","06/09/2017","3228","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","998","06/09/2017","3229","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","998","06/09/2017","3230","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Patient_Guide.pdf" "58","Thalomid","998","06/09/2017","3231","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Emergency_Contraception_Brochure.pdf" "58","Thalomid","998","06/09/2017","3232","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","998","06/09/2017","3233","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","998","06/09/2017","3234","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","998","06/09/2017","3235","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_Full.pdf" "58","Thalomid","998","06/09/2017","3236","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-09_REMS_Document.pdf" "350","Addyi","999","06/16/2017","3237","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017_06-16_Prescriber_Enrollment_Form.pdf" "350","Addyi","999","06/16/2017","3238","Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Prescriber_and_Pharmacy_Training .pdf" "350","Addyi","999","06/16/2017","3239","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Knowledge_Assessment.pdf" "350","Addyi","999","06/16/2017","3240","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_REMS_Website_Screenshots.pdf" "350","Addyi","999","06/16/2017","3241","Patient-Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Patient_Provider_Agreement_Form.pdf" "350","Addyi","999","06/16/2017","3242","Multiple Locations Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Multiple_Locations_Outpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","999","06/16/2017","3243","Individual Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Individual_Location_Outpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","999","06/16/2017","3244","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Inpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","999","06/16/2017","3245","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_Full.pdf" "350","Addyi","999","06/16/2017","3246","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2017-06-16_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3247","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Recognizing_Psychiatric_Disorders_in_Adolescents_and_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3248","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3249","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Monthly_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3250","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Full.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3251","Pharmacist Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3252","The Guide to Best Practices","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Istoretinoin_2017-06-17_The_Guide_to_Best_Practices.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3253","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Information_Informed_Consent_for_Females_of_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3254","Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Educational_Kit_for_Males_and_Females_of_Non_Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3255","Isotretinoin Educational Kit for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Educational_Kit_for_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3256","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Request_for_Exemption_for_Patients_with_Serious_Medical_Reasons.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3257","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Office_Staff_Designee_Registration_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3258","Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Guide_to_Isotretinoin_for_Male_Patients_and_Female_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3259","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3260","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Instructions_for_Managing_Office_Staff_Designees.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3261","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3262","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Guide_to_Isotretinoin_for_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3263","Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3264","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3265","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_REMS_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3266","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected, and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Istoretinoin_2017-06-17_DVDs_for_prescriber_use_in_patient_counseling_Be_Prepared_Be_Protected_and_Be_Aware_The_Risk_of_Pregnancy.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3267","Wholesaler Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Wholesaler_Agreement.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3268","Wholesaler to Wholesaler Shipment Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Wholesaler_to_Wholesaler_Shipment_Request_Form.pdf" "24","Isotretinoin iPLEDGE","1000","06/17/2017","3269","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Information_Informed_Consent_for_all_patients.pdf" "58","Thalomid","1001","06/27/2017","3270","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Prescriber_Enrollment_Form.pdf" "58","Thalomid","1001","06/27/2017","3271","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Prescription_Form.pdf" "58","Thalomid","1001","06/27/2017","3272","Patient Prescription Form - Veterans Health Administration (VHA) Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Prescription_Form_VHA_Only.pdf" "58","Thalomid","1001","06/27/2017","3273","Prescriber Guide to Thalomid REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Prescriber_Guide.pdf" "58","Thalomid","1001","06/27/2017","3274","Thalomid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_At_A_Glance.pdf" "58","Thalomid","1001","06/27/2017","3275","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Celgene_Risk_Management_Website_Screenshots.pdf" "58","Thalomid","1001","06/27/2017","3276","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Pharmacy_Guide.pdf" "58","Thalomid","1001","06/27/2017","3277","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "58","Thalomid","1001","06/27/2017","3278","Celgene REMS Programs Pharmacy Training: the Thalomid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Celgene_REMS_Programs_Pharmacy_Training.pdf" "58","Thalomid","1001","06/27/2017","3279","Pharmacy Certification Quiz (the Thalomid REMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","1001","06/27/2017","3280","Patient-Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Male.pdf" "58","Thalomid","1001","06/27/2017","3281","Patient-Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Male_Child.pdf" "58","Thalomid","1001","06/27/2017","3282","Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","1001","06/27/2017","3283","Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","1001","06/27/2017","3284","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","1001","06/27/2017","3285","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","1001","06/27/2017","3286","Patient Guide to Thalomid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Guide.pdf" "58","Thalomid","1001","06/27/2017","3287","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Emergency_Contraception_Brochure.pdf" "58","Thalomid","1001","06/27/2017","3288","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Survey_Reminder_Card.pdf" "58","Thalomid","1001","06/27/2017","3289","Thalomid REMS Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","1001","06/27/2017","3290","Thalomid REMS Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","1001","06/27/2017","3291","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Full.pdf" "58","Thalomid","1001","06/27/2017","3292","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_REMS_Document.pdf" "58","Thalomid","1001","06/27/2017","3293","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Welcome_Letter.pdf" "46","Revlimid","1002","06/27/2017","3294","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Prescriber_Enrollment_Form.pdf" "46","Revlimid","1002","06/27/2017","3295","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Patient_Prescription_Form.pdf" "46","Revlimid","1002","06/27/2017","3296","Patient Prescription Form - Veterans Health Administration (VHA) Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Patient_Prescription_Form_VHA_Only.pdf" "46","Revlimid","1002","06/27/2017","3297","Prescriber Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Prescriber_Guide.pdf" "46","Revlimid","1002","06/27/2017","3298","Revlimid REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_At_A_Glance.pdf" "46","Revlimid","1002","06/27/2017","3299","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Welcome_Letter.pdf" "46","Revlimid","1002","06/27/2017","3300","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Celgene_Risk_Management_Website_Screenshots.pdf" "46","Revlimid","1002","06/27/2017","3301","Pharmacy Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Pharmacy_Guide.pdf" "46","Revlimid","1002","06/27/2017","3302","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "46","Revlimid","1002","06/27/2017","3303","Celgene REMS Programs Pharmacy Training: Revlimid REMS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Celgene_REMS_Pharmacy_Training.pdf" "46","Revlimid","1002","06/27/2017","3304","Pharmacy Certification Quiz (the Revlimid RMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","1002","06/27/2017","3305","Patient-Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Adult_Male.pdf" "46","Revlimid","1002","06/27/2017","3306","Patient-Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Male_Child.pdf" "46","Revlimid","1002","06/27/2017","3307","Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","1002","06/27/2017","3308","Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","1002","06/27/2017","3309","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","1002","06/27/2017","3310","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","1002","06/27/2017","3311","Patient Guide to Revlimid REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Patient_Guide.pdf" "46","Revlimid","1002","06/27/2017","3312","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Emergency_Contraception_Brochure.pdf" "46","Revlimid","1002","06/27/2017","3313","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Patient_Survey_Reminder_Card.pdf" "46","Revlimid","1002","06/27/2017","3314","Revlimid REMS Program Education and Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","1002","06/27/2017","3315","Revlimid REMS Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","1002","06/27/2017","3316","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_Full.pdf" "46","Revlimid","1002","06/27/2017","3317","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2017-06-27_REMS_Document.pdf" "41","Pomalyst","1003","06/27/2017","3318","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","1003","06/27/2017","3319","Patient Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Prescription_Form.pdf" "41","Pomalyst","1003","06/27/2017","3320","Patient Prescription Form - Veterans Health Administration (VHA) Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Prescription_Form_Veterans_Health_Administration_VHA_Only.pdf" "41","Pomalyst","1003","06/27/2017","3321","Prescriber Guide to Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Prescriber_Guide.pdf" "41","Pomalyst","1003","06/27/2017","3322","Pomalyst REMS At-A-Glance","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_At_A_Glance.pdf" "41","Pomalyst","1003","06/27/2017","3323","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Welcome_Letter.pdf" "41","Pomalyst","1003","06/27/2017","3324","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Celgene_Risk_Management_Website_Screenshots.pdf" "41","Pomalyst","1003","06/27/2017","3325","Pharmacy Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Pharmacy_Guide.pdf" "41","Pomalyst","1003","06/27/2017","3326","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "41","Pomalyst","1003","06/27/2017","3327","Celgene REMS Programs Pharmacy Training: the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","1003","06/27/2017","3328","Patient-Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Male.pdf" "41","Pomalyst","1003","06/27/2017","3329","Patient-Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Male_Child.pdf" "41","Pomalyst","1003","06/27/2017","3330","Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1003","06/27/2017","3331","Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1003","06/27/2017","3332","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1003","06/27/2017","3333","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1003","06/27/2017","3334","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","1003","06/27/2017","3335","Patient Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Guide.pdf" "41","Pomalyst","1003","06/27/2017","3336","Pomalyst REMS Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","1003","06/27/2017","3337","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Resource_Pack_Envelope.pdf" "41","Pomalyst","1003","06/27/2017","3338","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Full.pdf" "41","Pomalyst","1003","06/27/2017","3339","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_REMS_Document.pdf" "41","Pomalyst","1003","06/27/2017","3340","Pharmacy Certification Quiz (the Pomalyst REMS Program)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","1003","06/27/2017","3341","Patient Survey Reminder Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Survey_Reminder_Card.pdf" "45","Qsymia","1004","07/03/2017","3342","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_full.pdf" "45","Qsymia","1004","07/03/2017","3343","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_document.pdf" "45","Qsymia","1004","07/03/2017","3344","Risk of Birth Defects with Qsymia patient brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Patient_brochure.pdf" "45","Qsymia","1004","07/03/2017","3345","Healthcare Provider Counseling Tool for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Counseling_Tool.pdf" "45","Qsymia","1004","07/03/2017","3346","Prescriber Dosing and Management Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Prescriber_Checklist.pdf" "45","Qsymia","1004","07/03/2017","3347","Online Qsymia REMS Healthcare Provider Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Online_training_HCP.pdf" "45","Qsymia","1004","07/03/2017","3348","Print Qsymia REMS Healthcare Provider Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Print_training_HCP.pdf" "45","Qsymia","1004","07/03/2017","3349","Pharmacy Enrollment Form, Independent Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Independent_Pharmacy_Enrollment_Form.pdf" "45","Qsymia","1004","07/03/2017","3350","Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Chain_Pharmacy_Enrollment_Form.pdf" "45","Qsymia","1004","07/03/2017","3351","Pharmacy Enrollment Form, Mail Order Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Mail_Order_Pharmacy_Enrollment.pdf" "45","Qsymia","1004","07/03/2017","3352","Online Qsymia REMS Pharmacy Training module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Online_module_pharmacy.pdf" "45","Qsymia","1004","07/03/2017","3353","Print Qsymia REMS Pharmacy Training module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Print_module_pharmacy.pdf" "45","Qsymia","1004","07/03/2017","3354","Dear Healthcare Provider (DHCP) letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_DHCP_letter.pdf" "45","Qsymia","1004","07/03/2017","3355","Dear Medical Society letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_DMS_letter.pdf" "45","Qsymia","1004","07/03/2017","3356","REMS website screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_website_screenshot.pdf" "341","Blincyto","1005","07/12/2017","3357","REMS Letter for Healthcare Providers (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Letter_for_Healthcare_Providers_email_and_print_versions.pdf" "341","Blincyto","1005","07/12/2017","3358","REMS Letter for Hospital and Home Healthcare Pharmacists (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Letter_for_Hospital_and_Home_Healthcare_Pharmacists_email_and_print_versions.pdf" "341","Blincyto","1005","07/12/2017","3359","REMS Letter for Professional Societies (email and print versions)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Letter_for_Professional_Societies_email_and_print_versions.pdf" "341","Blincyto","1005","07/12/2017","3360","Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Fact_Sheet_for_Providers.pdf" "341","Blincyto","1005","07/12/2017","3361","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Website_Screenshot.pdf" "341","Blincyto","1005","07/12/2017","3362","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_Full.pdf" "341","Blincyto","1005","07/12/2017","3363","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2017-07-12_REMS_Document.pdf" "366","testosterone 1.62% (ANDA 205781)","1006","07/12/2017","3364","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_1.62_ANDA_205781_2017-07-12_Full.pdf" "366","testosterone 1.62% (ANDA 205781)","1006","07/12/2017","3365","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_1.62_ANDA_205781_2017-07-12_REMS_Document.pdf" "28","Letairis","1008","07/21/2017","3366","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Prescriber_Enrollment_and_Agreement_Form.pdf" "28","Letairis","1008","07/21/2017","3367","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Prescriber_Guide.pdf" "28","Letairis","1008","07/21/2017","3368","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "28","Letairis","1008","07/21/2017","3369","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Patient_Enrollment_and_Consent_Form.pdf" "28","Letairis","1008","07/21/2017","3370","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Change_in_Reproductive_Potential_Status_and_Pre-Pubertal_Annual_Verification_Form.pdf" "28","Letairis","1008","07/21/2017","3371","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_REMS_Website_Screenshots.pdf" "28","Letairis","1008","07/21/2017","3372","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_REMS_Document.pdf" "28","Letairis","1008","07/21/2017","3373","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017-07-21_Full.pdf" "343","Natpara","1010","08/04/2017","3374","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Document.pdf" "343","Natpara","1010","08/04/2017","3375","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Full.pdf" "343","Natpara","1010","08/04/2017","3376","Training Module for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Training_Module_for_Prescribers.pdf" "343","Natpara","1010","08/04/2017","3377","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Presciber_Enrollment_Form.pdf" "343","Natpara","1010","08/04/2017","3378","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Program_An_Introduction.pdf" "343","Natpara","1010","08/04/2017","3379","Training Module for Pharmacy Representatives","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Training_Module_for_Pharmacy_Representatives.pdf" "343","Natpara","1010","08/04/2017","3380","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Pharmacy_Enrollment_Form.pdf" "343","Natpara","1010","08/04/2017","3381","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Patient_Brochure.pdf" "343","Natpara","1010","08/04/2017","3382","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Patient_Prescriber_Acknowledgment_Form.pdf" "343","Natpara","1010","08/04/2017","3384","Frequently Asked Questions (FAQ)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Frequently_Asked_Questions_FAQ.pdf" "343","Natpara","1010","08/04/2017","3385","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Website_Screenshots.pdf" "367","testosterone (ANDA 205328)","1011","08/07/2017","3386","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_(ANDA_205328)_2017-08-07_REMS_Document.pdf" "367","testosterone (ANDA 205328)","1011","08/07/2017","3387","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_(ANDA_205328)_2017-08-07_Full.pdf" "318","Vogelxo","1012","08/11/2017","3388","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vogelxo_2017-08-11_REMS_Document.pdf" "368","Kymriah","1013","08/30/2017","3392","Live Training Program Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_Live_Training_Program_Slides.pdf" "368","Kymriah","1013","08/30/2017","3393","Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_Program_Knowledge_Assessment.pdf" "368","Kymriah","1013","08/30/2017","3394","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_Program_Hospital_Enrollment_Form.pdf" "368","Kymriah","1013","08/30/2017","3395","REMS Program website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_Program_Website.pdf" "368","Kymriah","1013","08/30/2017","3396","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_Program_Patient_Wallet_Card.pdf" "368","Kymriah","1013","08/30/2017","3397","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_REMS_document.pdf" "368","Kymriah","1013","08/30/2017","3398","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2017_08_30_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3399","Prescriber Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017_09-07_Prescriber_Program_Overview.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3400","Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Education_Program_for_Prescribers_and_Pharmacists.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3401","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3402","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3403","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Patient_Prescriber_Agreement_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3404","Patient and Caregiver Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Patient_and_Caregiver_Overview.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3405","Frequently Asked Questions (FAQs)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Frequently_Asked_Questions_FAQs.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3406","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_REMS_Website_Screenshot.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3407","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Dear_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3408","Program Overview (Independent Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Program_Overview_for_Independent_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3409","Program Overview (Chain Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Program_Overview_for_Chain_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3410","Program Overview (Closed System Outpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Program_Overview_for_Closed_System_Outpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3411","Program Overview (Inpatient Pharmacy)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Program_Overview_for_Inpatient_Pharmacies.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3412","Pharmacy Enrollment Form (Independent Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Independent_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3413","Pharmacy Enrollment Form (Chain Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Chain_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3414","Pharmacy Enrollment Form (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3415","Dear Pharmacy Letter (Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Dear_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3416","Dear Pharmacy Letter (Inpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Dear_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3417","Dear Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Dear_Distributor_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3418","Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Wholesaler_Distributor_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3419","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3420","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","3421","Pharmacy Enrollment (Closed System Outpatient)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2017-09-07_Closed_System_Outpatient_Pharmacy_Enrollment_Form.pdf" "61","Tracleer","1015","09/05/2017","3422","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Prescriber_Enrollment_and_Agreement_Form.pdf" "61","Tracleer","1015","09/05/2017","3423","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Patient_Enrollment_and_Consent_Form.pdf" "61","Tracleer","1015","09/05/2017","3424","Patient Enrollment and Consent Form (VA USE ONLY)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Patient_Enrollment_and_Consent_Form_VA_USE_ONLY.pdf" "61","Tracleer","1015","09/05/2017","3425","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Prescriber_and_Pharmacy_Guide.pdf" "61","Tracleer","1015","09/05/2017","3426","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Guide_for_Patients.pdf" "61","Tracleer","1015","09/05/2017","3427","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Change_in_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "61","Tracleer","1015","09/05/2017","3428","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_REMS_Website_Screenshots.pdf" "61","Tracleer","1015","09/05/2017","3429","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Inpatient_Pharmacy_Enrollment_Form.pdf" "61","Tracleer","1015","09/05/2017","3430","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_Full.pdf" "61","Tracleer","1015","09/05/2017","3431","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017-09-05_REMS_Document.pdf" "76","Opsumit","1093","10/16/2018","3432","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_REMS_Full.pdf" "76","Opsumit","1024","08/25/2017","3433","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_REMS_full.pdf" "76","Opsumit","1024","08/25/2017","3434","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_REMS_document.pdf" "76","Opsumit","1024","08/25/2017","3435","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","1024","08/25/2017","3436","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","1024","08/25/2017","3437","Patient Enrollment and Consent Form (VA use only)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Patient_Enrollment_and_Consent_Form_for_VA_use_only.pdf" "76","Opsumit","1024","08/25/2017","3438","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","1024","08/25/2017","3439","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","1024","08/25/2017","3440","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "76","Opsumit","1024","08/25/2017","3441","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_Change_in_Reproductive_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "76","Opsumit","1024","08/25/2017","3442","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2017_08_25_REMS_Website_Screenshots.pdf" "373","testosterone 1% (ANDA 091073)","1028","09/18/2017","3443","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_1_ANDA_091073_2017_9_18_REMS_Document.pdf" "373","testosterone 1% (ANDA 091073)","1028","09/18/2017","3444","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_1_ANDA_091073_2017_9_18_REMS_Full.pdf" "28","Letairis","1029","09/27/2017","3446","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_REMS_Document.pdf" "28","Letairis","1029","09/27/2017","3447","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Prescriber_Guide.pdf" "28","Letairis","1029","09/27/2017","3448","Guide for Females Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Guide_for_Females_Who_Can_Get_Pregnant.pdf" "28","Letairis","1029","09/27/2017","3449","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Prescriber_Enrollment_and_Agreement_Form.pdf" "28","Letairis","1029","09/27/2017","3450","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Patient_Enrollment_and_Consent_Form.pdf" "28","Letairis","1029","09/27/2017","3451","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Change_in_Reproductive_Potential_Status_and_Pre-Pubertal_Annual_Verification_Form.pdf" "28","Letairis","1029","09/27/2017","3452","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_REMS_Website_Screenshots.pdf" "28","Letairis","1029","09/27/2017","3454","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2017_09_27_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3455","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Dear_Healthcare_Provider_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3456","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Training_Guide_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3457","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Healthcare_Provider_Training.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3458","Important Safety Information about emtricitabine/tenofovir disoproxil fumarate for a Pre-exposure Prophylaxis (PrEP) Indication for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Important_Safety_Information_for_a_Pre_exposure_Prophylaxis_(PrEP)_Indication_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3459","Important Safety Information about emtricitabine/tenofovir disoproxil fumarate to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Important_Safety_Information_to_Reduce_the_Risk_of_Getting_Human_Immunodeficiency_Virus_1_(HIV-1)_Infection.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3460","Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Agreement_Form.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3461","Checklist for Prescribers: Initiation of emtricitabine/tenofovir disoproxil fumarate for Pre-expsure Prophylaxis (PrEP) to manage an uninfected individual considering or taking emtricitabine/tenofovir disoproxil fumarate for a PrEP Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Checklist_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3462","Safety Information Fact Sheet for Prescribers About emtricitabine/tenofovir disoproxil fumarate for a Pre-exposure Prophylasix (PrEP) Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3463","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3464","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","3465","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017-09-21_REMS_Website_Screenshots.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3466","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3467","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3468","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3469","Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3470","Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists”","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3471","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_REMS_Website_Screenshots.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3472","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_Full.pdf" "352","Suboxone/Subutex","1031","09/19/2017","3473","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2017-09-19_REMS_Document.pdf" "2","Adasuve","1032","10/10/2017","3474","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Full.pdf" "2","Adasuve","1032","10/10/2017","3475","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Document.pdf" "2","Adasuve","1032","10/10/2017","3476","Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Education_Program.pdf" "2","Adasuve","1032","10/10/2017","3477","Healthcare Facility Enrollment Information and Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Healthcare_Facility_Enrollment_Information_and_Form.pdf" "2","Adasuve","1032","10/10/2017","3478","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Healthcare_Provider_Brochure.pdf" "2","Adasuve","1032","10/10/2017","3479","Steps for Safe Use","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Steps_for_Safe_Use.pdf" "2","Adasuve","1032","10/10/2017","3480","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Website_Screenshots.pdf" "2","Adasuve","1032","10/10/2017","3481","Order Set/Protocol Template","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Order_Set_Protocol_Template.pdf" "364","Vigabatrin","1034","10/23/2017","3482","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_Prescriber_Enrollment_and_Agreement_Form.pdf" "364","Vigabatrin","1034","10/23/2017","3483","What You Need to Know About Vigabatrin Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_What_You_Need_To_Know_About_Vigabatrin_Treatment_A_Patient_Guide.pdf" "364","Vigabatrin","1034","10/23/2017","3484","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "364","Vigabatrin","1034","10/23/2017","3485","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","1034","10/23/2017","3486","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_SSS_2017-10-23_Full.pdf" "364","Vigabatrin","1034","10/23/2017","3487","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_REMS_Document.pdf" "364","Vigabatrin","1034","10/23/2017","3488","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2017-10-23_REMS_Website_Screenshots.pdf" "61","Tracleer","1033","10/20/2017","3489","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_REMS_Website_Screenshots.pdf" "61","Tracleer","1033","10/20/2017","3490","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_REMS_Document.pdf" "61","Tracleer","1033","10/20/2017","3491","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Prescriber_Enrollment_and_Agreement_Form.pdf" "61","Tracleer","1033","10/20/2017","3492","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Prescriber_and_Pharmacy_Guide.pdf" "61","Tracleer","1033","10/20/2017","3493","Patient Enrollment and Consent Form (VA USE ONLY)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Patient_Enrollment_and_Consent_Form_VA_Use_Only.pdf" "61","Tracleer","1033","10/20/2017","3494","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Patient_Enrollment_and_Consent_Form.pdf" "61","Tracleer","1033","10/20/2017","3495","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Inpatient_Pharmacy_Enrollment_Form.pdf" "61","Tracleer","1033","10/20/2017","3496","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Guide_for_Patients.pdf" "61","Tracleer","1033","10/20/2017","3497","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_Change_in_Reproductive_Potential_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "61","Tracleer","1033","10/20/2017","3498","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2017_10_20_REMS_full.pdf" "49","Soliris","1035","10/23/2017","3499","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Patient_Safety_Card.pdf" "49","Soliris","1035","10/23/2017","3500","Prescriber Introductory Letter and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Prescriber_Introductory_Letter_and_Enrollment_Form.pdf" "49","Soliris","1035","10/23/2017","3501","Patient Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Patient_Safety_Brochure_Important_Safety_Information.pdf" "49","Soliris","1035","10/23/2017","3502","Prescriber Safety Brochure, Important Safety Information about Soliris","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Prescriber_Safety_Brochure_Important_Safety_Information.pdf" "49","Soliris","1035","10/23/2017","3503","Dosing and Administration Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Dosing_and_Administration_Guide.pdf" "49","Soliris","1035","10/23/2017","3504","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_REMS_Website_Screenshot.pdf" "49","Soliris","1035","10/23/2017","3505","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_Full.pdf" "49","Soliris","1035","10/23/2017","3506","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-10-23_REMS_Document.pdf" "374","testosterone (ANDA 208061)","1036","10/23/2017","3507","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_ANDA_208061_2017-10-23_Full.pdf" "374","testosterone (ANDA 208061)","1036","10/23/2017","3508","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Testosterone_ANDA_208061_2017-10-23_REMS_Document.pdf" "27","Kynamro","1037","10/25/2017","3509","Kynamro REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_An_Introduction.pdf" "27","Kynamro","1037","10/25/2017","3510","Prescriber Certification Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescriber_Certification_Training_Module_and_Knowledge_Assessment .pdf" "27","Kynamro","1037","10/25/2017","3511","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescriber_Enrollment_Form.pdf" "27","Kynamro","1037","10/25/2017","3512","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Patient_Guide.pdf" "27","Kynamro","1037","10/25/2017","3513","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Patient_Prescriber_Acknowledgment_Form.pdf" "27","Kynamro","1037","10/25/2017","3514","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescription_Authorizaton_Form .pdf" "27","Kynamro","1037","10/25/2017","3515","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Letter_for_Healthcare_Providers.pdf" "27","Kynamro","1037","10/25/2017","3516","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_Website_Screenshot.pdf" "27","Kynamro","1037","10/25/2017","3517","Pharmacy Certification Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Pharmacy_Certification_Training_Module_and_Knowledge_Assessment.pdf" "27","Kynamro","1037","10/25/2017","3518","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Pharmacy_Enrollment_Form.pdf" "27","Kynamro","1037","10/25/2017","3519","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Letter_for_Pharmacists.pdf" "27","Kynamro","1037","10/25/2017","3520","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_document.pdf" "27","Kynamro","1037","10/25/2017","3521","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_full.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3522","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3523","Live Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Live_Training.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3524","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3525","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3526","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3527","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_REMS_Website_Screenshot.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3528","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_Full.pdf" "375","Yescarta and Tecartus","1038","10/18/2017","3529","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2017-10-18_REMS_Document.pdf" "357","Zinbryta","1039","11/01/2017","3530","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_full.pdf" "357","Zinbryta","1039","11/01/2017","3531","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Letter_for_Healthcare_Providers.pdf" "357","Zinbryta","1039","11/01/2017","3532","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Enrollment_Form.pdf" "357","Zinbryta","1039","11/01/2017","3533","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Guide.pdf" "357","Zinbryta","1039","11/01/2017","3534","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Status_Form.pdf" "357","Zinbryta","1039","11/01/2017","3535","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Wallet_Card.pdf" "357","Zinbryta","1039","11/01/2017","3536","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Pharmacy_Enrollment_Form.pdf" "357","Zinbryta","1039","11/01/2017","3537","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Enrollment_Form.pdf" "357","Zinbryta","1039","11/01/2017","3538","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Knowledge_Assessment.pdf" "357","Zinbryta","1039","11/01/2017","3539","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Program_Overview.pdf" "357","Zinbryta","1039","11/01/2017","3540","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_document.pdf" "357","Zinbryta","1039","11/01/2017","3541","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_Website_Screenshots.pdf" "357","Zinbryta","1039","11/01/2017","3542","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Training.pdf" "7","Axiron","1041","07/13/2017","3543","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2017_07_13_REMS_document.pdf" "376","Sublocade","1042","11/30/2017","3544","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_REMS_full.pdf" "376","Sublocade","1042","11/30/2017","3545","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_REMS_document.pdf" "376","Sublocade","1042","11/30/2017","3547","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1042","11/30/2017","3548","Fact Sheet: How to Obtain Sublocade","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_Fact_Sheet_How_to_Obtain_Sublocade.pdf" "376","Sublocade","1042","11/30/2017","3549","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1042","11/30/2017","3550","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2017_11_30_REMS_Website_Screenshot.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3551","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2017_11_30_REMS_full.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3552","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_REMS_Document.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3553","Health Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Health_Professional_Training.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3554","Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Patinet_Care_Program_Instructions_Brochure.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3555","Buy and Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Buy_and_Bill_Pharmacy_Service_Provider_Registration_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3556","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Healthcare_Facility_Registration_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3557","Multiple Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Multiple_Injection_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3558","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Patient_Registration_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3559","Post Injection Delirium Sedation Syndrome (PDSS) Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Post_Injection_Delirium_Sedation_Syndrome_(PDSS)_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3560","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Pharmacy_Registration_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3561","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Prescriber_Registration_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3562","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Single_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3563","Reconstitution and Administration Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_Reconstitution_and_Administration_Training.pdf" "74","Zyprexa Relprevv","1044","11/30/2017","3564","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_11_30_2017_REMS_Website_Screenshot.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3565","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_REMS_full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3566","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3567","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_REMS_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3568","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Dear_Health_Care_Provider_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3569","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Healthcare_Provider_Education_Slide_Deck.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3570","Important Safety Information about emtricitabine/tenofovir disoproxil for a Pre-exposure Prophylaxis (PrEP) Indication for Healthcare Providers fumarate","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08__Important_Safety_Information_about_emtricitabine_tenofovir_disoproxil_fumarate_for_Pre-exposure_Prophylaxis_(PrEP)_Indication_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3571","Important Safety Information about emtricitabine/tenofovir to Reduce the Risk of Getting Human Immunodeficiency Virus-1 (HIV-1) Infection","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Important_Safety_Information_about emtricitabine_tenofovir_disoproxil_fumarate_to_Reduce_the_Risk_of_Getting_Human Immunodeficiency_Virus-1_(HIV-1)_Infection.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3572","Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis (PrEP)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Agreement_Form_for_Initiating_emtricitabine_tenofovir_disoproxil_fumarate_for_Pre-exposure_Prophylaxis_(PrEP).pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3573","Checklist for Prescribers: Initiation of emtricitabine/tenofovir disoproxil fumarate for Pre-expsure Prophylaxis (PrEP) to manage an uninfected individual considering or taking emtricitabine/tenofovir disoproxil fumarate for a PrEP Indication","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Checklist_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3574","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_Training_Guide_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","3575","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_Tenofovir_2017_12_08_REMS_Website_Screenshots.pdf" "314","Myalept","1046","12/11/2017","3576","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept__2017_12_11_REMS_Full.pdf" "314","Myalept","1046","12/11/2017","3577","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_REMS_Document.pdf" "314","Myalept","1046","12/11/2017","3578","Myalert REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_Myalept_REMS_Program_An_Introduction.pdf" "314","Myalept","1046","12/11/2017","3579","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_Prescriber_Training_Module.pdf" "314","Myalept","1046","12/11/2017","3580","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_Prescriber_Enrollment_Form.pdf" "314","Myalept","1046","12/11/2017","3581","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_Prescription_Authorization_Form.pdf" "314","Myalept","1046","12/11/2017","3582","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_Myalept_REMS_Program_Website_Screenshot.pdf" "314","Myalept","1046","12/11/2017","3583","REMS Letter for Healthcare Providers (Infections)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2017_12_11_REMS_Letter_for_ Healthcare_Providers_(Infections).pdf" "314","Myalept","1447","03/06/2024","3584","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept__2024_03_06_REMS_Full.pdf" "362","Siliq","1053","01/26/2018","3585","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Full.pdf" "362","Siliq","1053","01/26/2018","3586","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Document.pdf" "362","Siliq","1053","01/26/2018","3587","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Prescriber_Enrollment_Form.pdf" "362","Siliq","1053","01/26/2018","3588","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1053","01/26/2018","3589","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Patient_Wallet_Card.pdf" "362","Siliq","1053","01/26/2018","3590","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Patient_Prescriber_Agreement_Form.pdf" "362","Siliq","1053","01/26/2018","3591","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Website_Screenshots.pdf" "321","Zydelig","1054","01/26/2018","3592","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_REMS_Full.pdf" "321","Zydelig","1054","01/26/2018","3593","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_REMS_Document.pdf" "321","Zydelig","1054","01/26/2018","3594","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_Letter_to_Healthcare_Providers.pdf" "321","Zydelig","1054","01/26/2018","3595","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_Letter_to_Professional_Societies.pdf" "321","Zydelig","1054","01/26/2018","3596","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_Fact_Sheet.pdf" "321","Zydelig","1054","01/26/2018","3597","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_01_26_Patient_Safety_Information_Card.pdf" "321","Zydelig","1055","02/06/2018","3598","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_REMS_Full.pdf" "321","Zydelig","1055","02/06/2018","3599","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_REMS_Document.pdf" "321","Zydelig","1055","02/06/2018","3600","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Letter_to_Healthcare_Providers.pdf" "321","Zydelig","1055","02/06/2018","3601","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Letter_for_Professional_Societies.pdf" "321","Zydelig","1055","02/06/2018","3602","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Fact_Sheet.pdf" "321","Zydelig","1055","02/06/2018","3603","Journal Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Journal_Piece.pdf" "321","Zydelig","1055","02/06/2018","3604","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Website_Screenshots.pdf" "321","Zydelig","1055","02/06/2018","3605","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_02_06_Patient_Safety_Information_Card.pdf" "378","testosterone (ANDA 209533)","1056","01/30/2018","3606","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_ANDA_209533_2018_01_30_REMS_Document.pdf" "376","Sublocade","1057","02/09/2018","3607","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_REMS_Full.pdf" "376","Sublocade","1057","02/09/2018","3608","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_REMS_Document.pdf" "376","Sublocade","1057","02/09/2018","3609","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_Healthcare-Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1057","02/09/2018","3610","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_Healthcare_Provider_Letter.pdf" "376","Sublocade","1057","02/09/2018","3611","Fact Sheet: How to Obtain Sublocade","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_Fact_Sheet_How_to_Obtain_Sublocade.pdf" "376","Sublocade","1057","02/09/2018","3612","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2018_02_09_REMS_Website_Screenshot.pdf" "376","Sublocade","1059","03/08/2018","3619","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_8_2018_REMS_Full.pdf" "376","Sublocade","1059","03/08/2018","3620","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_REMS_Document.pdf" "376","Sublocade","1059","03/08/2018","3621","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1059","03/08/2018","3622","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Healthcare_Provider_Letter.pdf" "376","Sublocade","1059","03/08/2018","3623","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Fact_Sheet.pdf" "376","Sublocade","1059","03/08/2018","3624","Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Website-Screenshot.pdf" "321","Zydelig","1060","03/22/2018","3625","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_REMS_Full.pdf" "321","Zydelig","1060","03/22/2018","3626","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_REMS_Document.pdf" "321","Zydelig","1060","03/22/2018","3627","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Fact_Sheet.pdf" "321","Zydelig","1060","03/22/2018","3628","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Letter_to_Healthcare_Providers.pdf" "321","Zydelig","1060","03/22/2018","3629","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Letter_for_Professional_Societies.pdf" "321","Zydelig","1060","03/22/2018","3630","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Patient_Safety_Information_Card.pdf" "321","Zydelig","1060","03/22/2018","3631","Journal Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Journal_Piece.pdf" "321","Zydelig","1060","03/22/2018","3632","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2018_03_22_Website_Screenshots.pdf" "341","Blincyto","1061","03/29/2018","3633","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_REMS_Full.pdf" "341","Blincyto","1061","03/29/2018","3634","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_REMS_Document.pdf" "341","Blincyto","1061","03/29/2018","3635","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_Letter_for_Healthcare_Provider.pdf" "341","Blincyto","1061","03/29/2018","3636","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_Letter_for_Hospital_and_Home_Healthcare_Pharmacists.pdf" "341","Blincyto","1061","03/29/2018","3637","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_Letter_for_Professional_Societies.pdf" "341","Blincyto","1061","03/29/2018","3638","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_Fact_Sheet.pdf" "341","Blincyto","1061","03/29/2018","3639","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_03_29_REMS_Website_Screenshot.pdf" "341","Blincyto","1062","04/10/2018","3640","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_REMS_Full.pdf" "341","Blincyto","1062","04/10/2018","3641","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_REMS_Document.pdf" "341","Blincyto","1062","04/10/2018","3642","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_Letter_for_Healthcare_Provider.pdf" "341","Blincyto","1062","04/10/2018","3643","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_Letter_for Hospital_and _Home_Healthcare_Pharmacists.pdf" "341","Blincyto","1062","04/10/2018","3644","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_Letter_for_Professional_Societies.pdf" "341","Blincyto","1062","04/10/2018","3645","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_Fact_Sheet.pdf" "341","Blincyto","1062","04/10/2018","3646","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2018_04_10_REMS_Website_Screenshots.pdf" "63","Tysabri","1063","04/18/2018","3647","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_REMS_Full.pdf" "63","Tysabri","1063","04/18/2018","3648","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_REMS_Document.pdf" "63","Tysabri","1063","04/18/2018","3649","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_6-Month_Discontinuation_Questionnaire_(CD).pdf" "63","Tysabri","1063","04/18/2018","3650","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_6-Month_Discontinuation_Questionnaire_(MS).pdf" "63","Tysabri","1063","04/18/2018","3651","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Certified_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1063","04/18/2018","3652","Change Prescriber Authorization Form","" "63","Tysabri","1063","04/18/2018","3653","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Helpful_Information_for_ Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_(MS).pdf" "63","Tysabri","1063","04/18/2018","3654","Infusion Site Enrollment Form","" "63","Tysabri","1063","04/18/2018","3655","Initial Discontinuation Questionnaire (CD)","" "63","Tysabri","1063","04/18/2018","3656","Initial Discontinuation Questionnaire (MS)","" "63","Tysabri","1063","04/18/2018","3657","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Patient_Status_Report_and_Reauthorization_ Questionnaire_(CD).pdf" "63","Tysabri","1063","04/18/2018","3658","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Patient_Status_Report_and_Reauthorization_Questionnaire_(MS).pdf" "63","Tysabri","1063","04/18/2018","3659","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Pre-Infusion_Patient_Checklist.pdf" "63","Tysabri","1063","04/18/2018","3660","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Prescriber_Pateint_Enrollment_Form_(CD).pdf" "63","Tysabri","1063","04/18/2018","3661","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Prescriber_Patient_Enrollment_Form_(MS).pdf" "63","Tysabri","1063","04/18/2018","3662","TOUCH On-Line REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_TOUCH_On-Line_REMS_Website_Screenshots.pdf" "63","Tysabri","1063","04/18/2018","3663","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_TOUCH_Prescribing_ Program_Educational_Slide_Set.pdf" "63","Tysabri","1063","04/18/2018","3664","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_TOUCH_Prescribing_Program_Overview.pdf" "63","Tysabri","1063","04/18/2018","3665","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_18_Understanding_PML_for_Gastroenterologists.pdf" "380","Jynarque","1065","04/23/2018","3666","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_REMS_Full.pdf" "380","Jynarque","1065","04/23/2018","3667","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_REMS_Document.pdf" "380","Jynarque","1065","04/23/2018","3668","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_Prescriber Enrollment Form.pdf" "380","Jynarque","1065","04/23/2018","3669","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_Patient Enrollment Form.pdf" "380","Jynarque","1065","04/23/2018","3670","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_Outpatient Pharmacy Enrollment Form.pdf" "380","Jynarque","1065","04/23/2018","3671","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23_Inpatient Pharmacy Enrollment Form.pdf" "380","Jynarque","1065","04/23/2018","3672","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Program Overview.pdf" "380","Jynarque","1065","04/23/2018","3673","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Prescriber Training.pdf" "380","Jynarque","1065","04/23/2018","3674","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Prescriber Knowledge Assessment.pdf" "380","Jynarque","1065","04/23/2018","3675","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Patient Guide.pdf" "380","Jynarque","1065","04/23/2018","3676","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Patient Status Form.pdf" "380","Jynarque","1065","04/23/2018","3677","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Liver Adverse Events Reporting Form .pdf" "380","Jynarque","1065","04/23/2018","3678","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 Letter for Healthcare Providers.pdf" "380","Jynarque","1065","04/23/2018","3679","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_04_23 REMS Website Screenshots.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3680","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Full.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3681","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3682","The Guide to Best Practices","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_The_Guide_to_Best_Practices .pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3683","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3684","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23Instructions for Managing Office Staff Designees .pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3685","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_website screenshots.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3686","Pharmacists Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacists Guide.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3687","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacy_Enrollment-form.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3688","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Request for Exemption for Patients with Serious Medical Reasons.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3689","Wholesaler Shipment Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Shipment Request Form.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3690","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Recognizing Psychiatric Disorders in Adolescents and Young Adults.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3691","Wholesaler Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Agreement.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3692","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected, and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_DVDs for prescriber use in patient counseling.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3693","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Informed Consent for Females of Reproductive Potential.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3694","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Informed Consent for all patients.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3695","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Guide to Isotretinoin for Female Patients Who Can Get Pregnant.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3696","Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin _2018_04_23_ Educational Kit for Males and Females of Non-Reproductive Potential.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3697","Patient Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Comprehension Questions.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3698","Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patinet_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","1067","04/23/2018","3700","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Office Staff Designee Registration Form.pdf" "63","Tysabri","1068","04/30/2018","3701","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1068","04/30/2018","3702","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_TOUCH_Prescribing_Program_Overview.pdf" "63","Tysabri","1068","04/30/2018","3703","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_TOUCH_Prescribing_ Program_Educational_Slide_Set.pdf" "63","Tysabri","1068","04/30/2018","3704","TOUCH On-Line REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_TOUCH_On-Line_REMS_Website_Screenshots.pdf" "63","Tysabri","1068","04/30/2018","3705","REMS full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_REMS_Full.pdf" "63","Tysabri","1068","04/30/2018","3706","REMS document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_REMS_Document.pdf" "63","Tysabri","1068","04/30/2018","3707","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Prescriber_Patient_Enrollment_Form_(MS).pdf" "63","Tysabri","1068","04/30/2018","3708","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Prescriber_Pateint_Enrollment_Form_(CD).pdf" "63","Tysabri","1068","04/30/2018","3709","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Pre-Infusion_Patient_Checklist.pdf" "63","Tysabri","1068","04/30/2018","3710","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Patient_Status_Report_and_Reauthorization_Questionnaire_(MS).pdf" "63","Tysabri","1068","04/30/2018","3711","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Patient_Status_Report_and_Reauthorization_ Questionnaire_(CD).pdf" "63","Tysabri","1068","04/30/2018","3712","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Helpful_Information_for_ Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_(MS).pdf" "63","Tysabri","1068","04/30/2018","3713","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Certified_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1068","04/30/2018","3714","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Initial_Discontinuation_Questionnaire_(MS).pdf" "63","Tysabri","1068","04/30/2018","3715","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_6-Month_Discontinuation_Questionnaire_(CD).pdf" "368","Kymriah","1069","05/01/2018","3716","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_REMS_Full.pdf" "368","Kymriah","1069","05/01/2018","3717","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_REMS_Document.pdf" "368","Kymriah","1069","05/01/2018","3718","Live Training Program Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_Live Trainng Program Slides.pdf" "368","Kymriah","1069","05/01/2018","3719","Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_Program Knowledge Assessment.pdf" "368","Kymriah","1069","05/01/2018","3720","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_Patient Wallet Card.pdf" "368","Kymriah","1069","05/01/2018","3721","Hospital Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah-2018_05_01_Hospital Enrollment Form.pdf" "368","Kymriah","1069","05/01/2018","3722","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2018_05_01_REMS Program Website Screenshots.pdf" "186","Iclusig","1070","05/07/2018","3723","REMS website screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_REMS_Website_Screenshots.pdf" "186","Iclusig","1070","05/07/2018","3724","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_Fact_Sheet.pdf" "186","Iclusig","1070","05/07/2018","3725","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_Letter_to_Healthcare_Providers.pdf" "186","Iclusig","1070","05/07/2018","3726","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_REMS_Document.pdf" "186","Iclusig","1070","05/07/2018","3727","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_REMS_Full.pdf" "186","Iclusig","1070","05/07/2018","3728","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Iclusig_2018_05_07_Letter_for_Professional_Societies.pdf" "350","Addyi","1071","05/09/2018","3729","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Prescriber_Enrollment_Form.pdf" "350","Addyi","1071","05/09/2018","3730","Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Prescriber_and_Pharmacy_Training.pdf" "350","Addyi","1071","05/09/2018","3731","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Knowledge_Assessment.pdf" "350","Addyi","1071","05/09/2018","3732","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Website_Screenshots.pdf" "350","Addyi","1071","05/09/2018","3733","Patient-Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Patient-Provider_Agreement_Form.pdf" "350","Addyi","1071","05/09/2018","3734","Multiple Locations Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Multiple_Locations_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1071","05/09/2018","3735","Individual Location Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Individual_Location_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1071","05/09/2018","3736","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Inpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1071","05/09/2018","3737","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Document.pdf" "350","Addyi","1071","05/09/2018","3738","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3743","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Dear_Healthcare_Provider_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3744","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Professional_Society_REMS_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3745","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3746","Checklist for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Checklist_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3747","Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Preexposure Prophylaxis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Agreement_Form_for_Initiating_Emtricitabine_Tenofovir_Disoproxil_Fumarate_for_Preexposure_Prophylaxis.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3748","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Training_Guide_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3749","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Healthcare_Provider_Education_Slide_Deck.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3750","Important Safety Information for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Important_Safety_Information_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3751","Important Safety Information for Adults Who Don't Have HIV","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Important_Safety_Information_for_Adults_Who_Dont_Have_HIV.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3752","Important Safety Information for Adolescents Who Don't Have HIV","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_Important_Safety_Information_for_Adolescents_Who_Dont_Have_HIV.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3753","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_REMS_Program_Website_Screenshots.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3754","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","3755","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_05_15_REMS_Full.pdf" "381","Palynziq","1074","05/24/2018","3756","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_REMS_Program_Overview.pdf" "381","Palynziq","1074","05/24/2018","3757","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_REMS_Program_Website_Screenshots.pdf" "381","Palynziq","1074","05/24/2018","3758","Safety Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Safety_Video.pdf" "381","Palynziq","1074","05/24/2018","3759","Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Wallet_Card.pdf" "381","Palynziq","1074","05/24/2018","3760","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Patient_Enrollment_Form.pdf" "381","Palynziq","1074","05/24/2018","3761","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Patient_Guide.pdf" "381","Palynziq","1074","05/24/2018","3762","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Pharmacy_Enrollment_Form.pdf" "381","Palynziq","1074","05/24/2018","3763","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Prescriber_Enrollment_Form.pdf" "381","Palynziq","1074","05/24/2018","3764","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Prescriber_Guide.pdf" "381","Palynziq","1074","05/24/2018","3765","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_Prescriber_Knowledge_Assessment.pdf" "381","Palynziq","1074","05/24/2018","3766","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_REMS_Document.pdf" "381","Palynziq","1074","05/24/2018","3767","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2018_05_24_REMS_Full.pdf" "380","Jynarque","1076","05/29/2018","3768","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Letter_for_Healthcare_Providers.pdf" "380","Jynarque","1076","05/29/2018","3769","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1076","05/29/2018","3770","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Patient_Guide.pdf" "380","Jynarque","1076","05/29/2018","3771","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Patient_Status_Form.pdf" "380","Jynarque","1076","05/29/2018","3772","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1076","05/29/2018","3773","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Prescriber_Training.pdf" "380","Jynarque","1076","05/29/2018","3774","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_REMS_Program_Website_Screenshots.pdf" "380","Jynarque","1076","05/29/2018","3775","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1076","05/29/2018","3776","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1076","05/29/2018","3777","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Patient_Enrollment_Form.pdf" "380","Jynarque","1076","05/29/2018","3778","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1076","05/29/2018","3779","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_Program_Overview.pdf" "380","Jynarque","1076","05/29/2018","3780","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_REMS_Document.pdf" "380","Jynarque","1076","05/29/2018","3781","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_05_29_REMS_Full.pdf" "25","Juxtapid","1077","06/04/2018","3782","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Fact_Sheet.pdf" "25","Juxtapid","1077","06/04/2018","3783","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","1077","06/04/2018","3784","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Letter_for_Pharmacists.pdf" "25","Juxtapid","1077","06/04/2018","3785","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Patient_Guide.pdf" "25","Juxtapid","1077","06/04/2018","3786","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1077","06/04/2018","3787","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1077","06/04/2018","3788","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1077","06/04/2018","3789","Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Prescriber_Authorization_Form.pdf" "25","Juxtapid","1077","06/04/2018","3790","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1077","06/04/2018","3791","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1077","06/04/2018","3792","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_REMS_Document.pdf" "25","Juxtapid","1077","06/04/2018","3793","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_REMS_Program_Website_Screenshots.pdf" "25","Juxtapid","1077","06/04/2018","3794","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_04_REMS_Full.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3795","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3796","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3797","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3798",""Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3799",""Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers"","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3800","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_REMS_Document.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3801","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_REMS_Program_Website_Screenshots.pdf" "352","Suboxone/Subutex","1079","06/11/2018","3802","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_06_11_REMS_Full.pdf" "25","Juxtapid","1080","06/18/2018","3803","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_REMS_Full.pdf" "25","Juxtapid","1080","06/18/2018","3804","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_REMS_Document.pdf" "25","Juxtapid","1080","06/18/2018","3805","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_REMS_Program_Website_Screenshots.pdf" "25","Juxtapid","1080","06/18/2018","3806","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1080","06/18/2018","3807","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1080","06/18/2018","3808","Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Prescriber_Authorization_Form.pdf" "25","Juxtapid","1080","06/18/2018","3809","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1080","06/18/2018","3810","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1080","06/18/2018","3811","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1080","06/18/2018","3812","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Patient_Guide.pdf" "25","Juxtapid","1080","06/18/2018","3813","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Letter_for_Pharmacists.pdf" "25","Juxtapid","1080","06/18/2018","3814","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","1080","06/18/2018","3815","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2018_06_18_Fact_Sheet.pdf" "71","Xiaflex","1081","07/10/2018","3816","Patient Counseling Tool, What You Need to Know About Xiaflex Treatment for Peyronie's Disease: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_Patient_Counseling_Tool_What_You_Need_to_Know_About_Xiaflex_Treatment_for_Peyronies_Disease_A_Patient_Guide.pdf" "71","Xiaflex","1081","07/10/2018","3817","Pharmacy Healthcare Setting Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1081","07/10/2018","3818","REMS Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_REMS_Program_Website_Screenshot.pdf" "71","Xiaflex","1081","07/10/2018","3819","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_Healthcare_Provider_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1081","07/10/2018","3820","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_REMS_Document.pdf" "71","Xiaflex","1081","07/10/2018","3821","REMS Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_REMS_Training_Guide_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1081","07/10/2018","3822","REMS Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_REMS_Training_Video_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1081","07/10/2018","3823","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_07_10_REMS_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3824","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Full.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3825","Training Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Training_Guide_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3826","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3827","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Program_Website_Screenshots.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3828","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Document.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3829","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Professional_Society_REMS_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3830","Important Safety Information for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Healthcare_Providers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3831","Important Safety Information for Adults Who Don't Have HIV","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Adults_Who_Dont_Have_HIV.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3832","Important Safety Information for Adolescents Who Don't Have HIV","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Adolescents_Who_Dont_Have_HIV.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3833","Healthcare Provider Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Healthcare_Provider_Education_Slide_Deck.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3834","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Dear_Healthcare_Provider_Letter.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3835","Checklist for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Checklist_for_Prescribers.pdf" "365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","3836","Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Agreement_Form_for_Initiating_Emtricitabine_Tenofovir_Disoproxil_Fumarate_for_Preexposure_Prophylaxis.pdf" "380","Jynarque","1083","07/30/2018","3837","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1083","07/30/2018","3838","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Letter for Healthcare_Providers.pdf" "380","Jynarque","1083","07/30/2018","3839","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1083","07/30/2018","3840","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1083","07/30/2018","3841","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Patient_Enrollment_Form.pdf" "380","Jynarque","1083","07/30/2018","3842","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Patient_Guide.pdf" "380","Jynarque","1083","07/30/2018","3843","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Patient_Status_Form.pdf" "380","Jynarque","1083","07/30/2018","3844","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1083","07/30/2018","3845","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1083","07/30/2018","3846","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Prescriber_Training.pdf" "380","Jynarque","1083","07/30/2018","3847","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_Program_Overview.pdf" "380","Jynarque","1083","07/30/2018","3848","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_REMS_Document.pdf" "380","Jynarque","1083","07/30/2018","3849","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_REMS_Program_Website_Screenshots.pdf" "380","Jynarque","1083","07/30/2018","3850","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_07_30_REMS_Full.pdf" "49","Soliris","1084","07/25/2018","3851","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_REMS_Full.pdf" "49","Soliris","1084","07/25/2018","3852","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_REMS_Document.pdf" "49","Soliris","1084","07/25/2018","3853","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_Prescriber_Enrollment_Form.pdf" "49","Soliris","1084","07/25/2018","3854","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_REMS_Website_Screenshots.pdf" "49","Soliris","1084","07/25/2018","3855","Presscriber Safety Information","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_Prescriber_Safety_Brochure.pdf" "49","Soliris","1084","07/25/2018","3856","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_Patient-Safety_Card.pdf" "49","Soliris","1084","07/25/2018","3857","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2018_07_25_Patient_Safety_Brochure.pdf" "313","Aveed","1085","09/01/2018","3858","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_REMS_Program_Website_Screenshots.pdf" "313","Aveed","1085","09/01/2018","3859","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_Education_Program_for_Healthcare_Settings.pdf" "313","Aveed","1085","09/01/2018","3860","What You Need To Know About Aveed Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_What_You_Need_To_Know_About_Aveed_Treatment_A_Patient_Guide.pdf" "313","Aveed","1085","09/01/2018","3861","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_Knowledge_Assessment.pdf" "313","Aveed","1085","09/01/2018","3862","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_REMS_Program_An_Introduction.pdf" "313","Aveed","1085","09/01/2018","3863","Education Program for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_Education_Program_for_Healthcare_Providers.pdf" "313","Aveed","1085","09/01/2018","3864","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_Healthcare_Setting_Enrollment_Form.pdf" "313","Aveed","1085","09/01/2018","3865","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_Healthcare_Provider_Enrollment_Form.pdf" "313","Aveed","1085","09/01/2018","3866","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_REMS_Document.pdf" "313","Aveed","1085","09/01/2018","3867","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_09_01_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3868","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3869","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3870","Prescriber Brochure, Office-Based Burprenorphine Therapy for Opioid Dependence","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_Prescribers_Brochure_Office_Based_BTOD_Important_Information_for_Prescribers.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3871","Pharmacist Brochure, Office-Based Buprenorphine Therapy for Opioid Dependence","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_Pharmacist_Brochure_Office_Based_BTOD_Important_Information_for_Pharmacists.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3872","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3873","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3874","BTOD REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_BTOD_REMS_Website_Screenshot.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","3875","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_09_07_Appropriate_Use_Checklist .pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3876","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_REMS_Full.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3877","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_REMS_Document.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3878","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Patient_Counseling_Guide.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3879","Professional Society Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Professional Society_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3880","Professional Society Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Professional Society_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3881","Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Healthcare_Provider_Letter_1.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3882","Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Healthcare_Provider_Letter_2.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3883","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18__REMS_Website_Screenshots.pdf" "17","Opioid Analgesic REMS","1087","09/18/2018","3884","FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_analgesic_2018_09_18_FDA_Blueprint.pdf" "382","Copiktra","1088","09/24/2018","3885","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_REMS_Program_Website_Screenshots.pdf" "382","Copiktra","1088","09/24/2018","3886","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_Fact_Sheet.pdf" "382","Copiktra","1088","09/24/2018","3887","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_Healthcare_Provider_REMS_Letter.pdf" "382","Copiktra","1088","09/24/2018","3888","Patient Safety Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_Patient_Safety_Wallet_Card.pdf" "382","Copiktra","1088","09/24/2018","3889","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_Professional_Society_REMS_Letter.pdf" "382","Copiktra","1088","09/24/2018","3890","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_REMS_Document.pdf" "382","Copiktra","1088","09/24/2018","3891","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2018_09_24_REMS_Full.pdf" "71","Xiaflex","1089","09/26/2018","3892","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_REMS_Program_Website_Screenshots.pdf" "71","Xiaflex","1089","09/26/2018","3893","What You Need to Know About Xiaflex Treatment for Peyronie's Disease: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_What_You_Need_to_Know_About_Xiaflex_Treatment_for_Peyronies_Disease_A_Patient_Guide.pdf" "71","Xiaflex","1089","09/26/2018","3894","Pharmacy/Healthcare Setting Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_Pharmacy_Healthcare_Setting_Enrollment_Form_For_Peyronies_Disease.pdf" "71","Xiaflex","1089","09/26/2018","3895","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_Healthcare_Provider_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1089","09/26/2018","3896","REMS Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_REMS_Training_Video_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1089","09/26/2018","3897","REMS Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_REMS_Training_Guide_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1089","09/26/2018","3898","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_REMS_Document.pdf" "71","Xiaflex","1089","09/26/2018","3899","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_09_26_REMS_Full.pdf" "346","Ionsys","1090","10/03/2018","3900","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Full.pdf" "346","Ionsys","1090","10/03/2018","3901","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_REMS_Document.pdf" "346","Ionsys","1090","10/03/2018","3902","Guide for Nurses and Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Guide_for_Nurses_and_Pharmacists.pdf" "346","Ionsys","1090","10/03/2018","3903","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Knowledge_Assessment.pdf" "346","Ionsys","1090","10/03/2018","3904","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Hospital_Enrollment_Form.pdf" "346","Ionsys","1090","10/03/2018","3905","Dear Healthcare Provider Letters","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Dear_Healthcare_Provider_Letters.pdf" "346","Ionsys","1090","10/03/2018","3906","Dear Hospital Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_Dear_Hospital_Pharmacy_Letter.pdf" "346","Ionsys","1090","10/03/2018","3907","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Website_Screenshots.pdf" "362","Siliq","1091","10/09/2018","3908","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_REMS_Full.pdf" "362","Siliq","1091","10/09/2018","3909","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_REMS_Document.pdf" "362","Siliq","1091","10/09/2018","3910","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_Prescriber_Enrollment_Form .pdf" "362","Siliq","1091","10/09/2018","3911","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1091","10/09/2018","3912","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_Patient_Wallet_Card.pdf" "362","Siliq","1091","10/09/2018","3913","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_Patient_Prescriber_Agreement_Form.pdf" "362","Siliq","1091","10/09/2018","3914","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_10_09_REMS_Website_Screenshots.pdf" "76","Opsumit","1093","10/16/2018","3927","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_REMS_Document.pdf" "76","Opsumit","1093","10/16/2018","3928","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","1093","10/16/2018","3929","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","1093","10/16/2018","3930","Patient Enrollment and Consent Form VA Use Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Patient_Enrollment_and_Consent_Form_VA_Use_Only.pdf" "76","Opsumit","1093","10/16/2018","3931","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","1093","10/16/2018","3932","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","1093","10/16/2018","3933","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Guide_for_Female_Patients.pdf" "76","Opsumit","1093","10/16/2018","3934","Change in Reproductive Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10_16_Change_in_Reproductive_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "76","Opsumit","1093","10/16/2018","3935","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2018_10-16_REMS_Website_Screenshots.pdf" "383","Tegsedi","1094","10/05/2018","3936","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_REMS_Full.pdf" "383","Tegsedi","1094","10/05/2018","3937","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10-REMS_Document.pdf" "383","Tegsedi","1094","10/05/2018","3938","Pharmacy Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10-Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1094","10/05/2018","3939","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1094","10/05/2018","3940","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Patient_Enrollment-Form.pdf" "383","Tegsedi","1094","10/05/2018","3941","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_REMS_Program_Overview.pdf" "383","Tegsedi","1094","10/05/2018","3942","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Prescriber_Training.pdf" "383","Tegsedi","1094","10/05/2018","3943","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1094","10/05/2018","3944","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Patient_Wallet_Card.pdf" "383","Tegsedi","1094","10/05/2018","3945","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Patient_Status_Form.pdf" "383","Tegsedi","1094","10/05/2018","3946","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10_Patient_Guide.pdf" "383","Tegsedi","1094","10/05/2018","3947","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2018_10__REMS_Program_Website_Screenshots.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3948","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_REMS_Full.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3949","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26-REMS_Document.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3950","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_REMS_Program_Website_Screenshots.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3951","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3952","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3953","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3954","Office Based Buprenorphine therapy for Opioid Dependence Imortant Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_Office_Based_Buprenorphine_therapy_for_Opioid_Dependence_Imortant_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1096","10/26/2018","3955","Office Based Buprenorphine therapy for Opioid Dependence Imortant Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2018_10_26_Office_Based_Buprenorphine_therapy_for_Opioid_Dependence_Imortant_Information_for_Prescribers.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3957","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_REMS_Program_Website_Screenshots.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3958","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3959","Risk Management Report Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Risk_Management_Report_Form.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3960","Pharmacy Knowledge Assessment Module A","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Pharmacy_Knowledge_Assessment_Module_A.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3961","Pharmacy Knowledge Assessment Module B","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Pharmacy_Knowledge_Assessment_Module_B.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3962","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3963","Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3964","Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3965","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Prescription_Form.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3966","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3967","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3968","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3969","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_REMS_Document.pdf" "345","Xywav and Xyrem","1097","10/26/2018","3970","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_2018_10_26_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3971","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3972","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3973","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3974","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3975","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3976","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_Prescriber_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3977","Pharmacist Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_Pharmacist_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","3978","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2018_10_31_REMS_Website_Screenshots.pdf" "384","Dsuvia","1099","11/02/2018","3979","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2018_11_02_REMS_Full.pdf" "384","Dsuvia","1099","11/02/2018","3980","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2018_11_02_REMS_Document.pdf" "384","Dsuvia","1099","11/02/2018","3981","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2018_11_02_Healthcare Setting_Enrollment_Form.pdf" "384","Dsuvia","1099","11/02/2018","3982","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2018_11_02_REMS_Website_Screenshots.pdf" "71","Xiaflex","1100","10/30/2018","3983","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Healthcare_Provider_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1100","10/30/2018","3984","Patient Counseling Tool - What You Need to Know About Xiaflex: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Patient_Counseling_Tool_What_You_Need_to_Know_About_Xiaflex_A_Patient_Guide.pdf" "71","Xiaflex","1100","10/30/2018","3985","Pharmacy/Healthcare Setting Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1100","10/30/2018","3986","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Document.pdf" "71","Xiaflex","1100","10/30/2018","3987","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Program_Website_Screenshots.pdf" "71","Xiaflex","1100","10/30/2018","3988","Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Training_Guide_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1100","10/30/2018","3989","Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Training_Video_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1100","10/30/2018","3990","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Full.pdf" "340","Lemtrada","1101","11/28/2018","3991","Patient Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Reminder_Letter.pdf" "340","Lemtrada","1101","11/28/2018","3992","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Status_Reminder_Letter.pdf" "340","Lemtrada","1101","11/28/2018","3993","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Program_Website_Screenshots.pdf" "340","Lemtrada","1101","11/28/2018","3994","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Infusion_Checklist.pdf" "340","Lemtrada","1101","11/28/2018","3995","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Letter_for_Healthcare_Providers.pdf" "340","Lemtrada","1101","11/28/2018","3996","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Status_Form.pdf" "340","Lemtrada","1101","11/28/2018","3997","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Prescription_Ordering_Form.pdf" "340","Lemtrada","1101","11/28/2018","3998","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Authorization_and_Baseline_Lab_Form.pdf" "340","Lemtrada","1101","11/28/2018","3999","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1101","11/28/2018","4000","What You Need to Know About Lemtrada Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_What_You_Need_to_Know_About_Lemtrada_Treatment_and_Infusion_Reactions_A_Patient_Guide.pdf" "340","Lemtrada","1101","11/28/2018","4001","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Education_Program_for_Healthcare_Facilities.pdf" "340","Lemtrada","1101","11/28/2018","4002","What You Need to Know About Lemtrada Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_What_You_Need_to_Know_About_Lemtrada_Treatment_A_Patient_Guide.pdf" "340","Lemtrada","1101","11/28/2018","4003","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Education_Program_for_Prescribers.pdf" "340","Lemtrada","1101","11/28/2018","4004","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Knowledge_Assessment.pdf" "340","Lemtrada","1101","11/28/2018","4005","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1101","11/28/2018","4006","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1101","11/28/2018","4007","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Program_Overview.pdf" "340","Lemtrada","1101","11/28/2018","4008","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Enrollment_Form.pdf" "340","Lemtrada","1101","11/28/2018","4009","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1101","11/28/2018","4010","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Document.pdf" "340","Lemtrada","1101","11/28/2018","4011","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Full.pdf" "28","Letairis","1102","11/30/2018","4012","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Full.pdf" "28","Letairis","1102","11/30/2018","4013","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Document.pdf" "28","Letairis","1102","11/30/2018","4014","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Website_Screenshots.pdf" "28","Letairis","1102","11/30/2018","4015","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Guide_for_Female_Patients.pdf" "28","Letairis","1102","11/30/2018","4016","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Patient-Enrollment_and_Consent_Form.pdf" "28","Letairis","1102","11/30/2018","4017","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Prescriber_Guide.pdf" "28","Letairis","1102","11/30/2018","4018","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018-11_30_Change_in_Reproductive_Potential_Status_and_PrePubertal_Annual_Verification_Form.pdf" "28","Letairis","1102","11/30/2018","4019","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Prescriber_Enrollment_and_Agreement_Form.pdf" "380","Jynarque","1103","12/01/2018","4020","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1103","12/01/2018","4021","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Letter_for_Healthcare_Providers.pdf" "380","Jynarque","1103","12/01/2018","4022","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1103","12/01/2018","4023","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1103","12/01/2018","4024","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Enrollment_Form.pdf" "380","Jynarque","1103","12/01/2018","4025","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Guide.pdf" "380","Jynarque","1103","12/01/2018","4026","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Status_Form.pdf" "380","Jynarque","1103","12/01/2018","4027","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1103","12/01/2018","4028","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1103","12/01/2018","4029","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Training.pdf" "380","Jynarque","1103","12/01/2018","4030","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Program_Overview.pdf" "380","Jynarque","1103","12/01/2018","4031","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Document.pdf" "380","Jynarque","1103","12/01/2018","4032","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Website_Screenshots.pdf" "380","Jynarque","1103","12/01/2018","4033","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Full.pdf" "149","Adempas","1105","12/06/2018","4034","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Guide_for_Female_Patients.pdf" "149","Adempas","1105","12/06/2018","4035","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_REMS_Program_Website_Screenshots.pdf" "149","Adempas","1105","12/06/2018","4036","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Prescriber_and_Pharmacy_Guide.pdf" "149","Adempas","1105","12/06/2018","4037","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Change_in_Reproductive_Potential_Status_and_Pre-Pubertal_Annual_Verification_Form.pdf" "149","Adempas","1105","12/06/2018","4038","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Inpatient_Pharmacy_Enrollment_Form.pdf" "149","Adempas","1105","12/06/2018","4039","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Patient_Enrollment_and_Consent_Form.pdf" "149","Adempas","1105","12/06/2018","4040","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_Prescriber_Enrollment_and_Agreement_Form.pdf" "149","Adempas","1105","12/06/2018","4041","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_REMS_Document.pdf" "149","Adempas","1105","12/06/2018","4042","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2018_12_06_REMS_Full.pdf" "63","Tysabri","1068","04/30/2018","4043","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1068","04/30/2018","4044","Initial Discontinuation Questionaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018_04_30_6-Month_Discontinuation_Questionnaire_(MS).pdf" "63","Tysabri","1068","04/30/2018","4045","Initial Discontinuation Questionaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2018-04_30_Initial_Discontinuation_Questionnaire_(CD).pdf" "356","Probuphine","1107","11/01/2018","4046","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Full.pdf" "356","Probuphine","1107","11/01/2018","4047","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Document.pdf" "356","Probuphine","1107","11/01/2018","4048","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Prescriber_Enrollment_Form.pdf" "356","Probuphine","1107","11/01/2018","4049","Healthcare Provider Who Performs Surgical Procedures Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Who_Perform_Surgical_Procedures_Enrollment_Form.pdf" "356","Probuphine","1107","11/01/2018","4050","Healthcare Provider Dual Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Dual_Enrollment_Form.pdf" "356","Probuphine","1107","11/01/2018","4051","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Pharmacy_Enrollment_Form.pdf" "356","Probuphine","1107","11/01/2018","4052","Sllides for Live Training Lecture and Practicum","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Slides_for_Live_Trainng_Lecture_and_Practicum.pdf" "356","Probuphine","1107","11/01/2018","4053","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Knowledge_Assessment.pdf" "356","Probuphine","1107","11/01/2018","4054","Criteria for Procedural Competency","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Criteria for_Procedural_Competency.pdf" "356","Probuphine","1107","11/01/2018","4055","Insertion/Removal Log","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_InsertionRemoval_Log.pdf" "356","Probuphine","1107","11/01/2018","4056","Surgical Procedures Recertificaation Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Surgical_Procedures_Recertification_Video.pdf" "356","Probuphine","1107","11/01/2018","4057","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_REMS_Webiste_Screenshots.pdf" "356","Probuphine","1107","11/01/2018","4058","Procedure Record for Recertification","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Procedure_Record_for_Recertification.pdf" "356","Probuphine","1107","11/01/2018","4059","What You Need to Know About Probuphine: A Patients Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_What_You_Need_to_Know_About_Probuphine_A_Patients_Guide.pdf" "356","Probuphine","1107","11/01/2018","4060","Healthcare Provider Who Performs Surgical Procedures Recertification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Probuphine_2018_11_01_Healthcare_Provider_Who_Performs_Surgical_Procedures_Recertification_Form.pdf" "313","Aveed","1108","12/19/2018","4061","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_REMS_Full.pdf" "313","Aveed","1108","12/19/2018","4062","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_REMS_Document.pdf" "313","Aveed","1108","12/19/2018","4063","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed-2018_12_19-Healthcare_Setting_Enrollment_Form.pdf" "313","Aveed","1108","12/19/2018","4064","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_Healthcare_Provider_Enrollment_Form.pdf" "313","Aveed","1108","12/19/2018","4065","Education Program for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19-Education_Program_for_Healthcare_Providers.pdf" "313","Aveed","1108","12/19/2018","4066","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_REMS_Program_An_Introduction.pdf" "313","Aveed","1108","12/19/2018","4067","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_Knowledge_Assessment.pdf" "313","Aveed","1108","12/19/2018","4068","What You Need to Know About Aveed Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.pdf" "313","Aveed","1108","12/19/2018","4069","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_Education-Program_for_Healthcare_Settings.pdf" "313","Aveed","1108","12/19/2018","4070","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2018_12_19_REMS_Webiste_Screenshots.pdf" "314","Myalept","1109","12/21/2018","4071","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Letter_for_Healthcare_Providers.pdf" "314","Myalept","1109","12/21/2018","4072","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescription_Authorization_Form.pdf" "314","Myalept","1109","12/21/2018","4073","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Program_Website_Screenshots.pdf" "314","Myalept","1109","12/21/2018","4074","Myalept REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Myalept_REMS_Program_An_Introduction.pdf" "314","Myalept","1109","12/21/2018","4075","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescriber_Enrollment_Form.pdf" "314","Myalept","1109","12/21/2018","4076","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescriber_Training_Module.pdf" "314","Myalept","1109","12/21/2018","4077","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Document.pdf" "314","Myalept","1109","12/21/2018","4078","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Full.pdf" "21","Gattex","1110","12/18/2018","4079","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Program_Website_Screenshots.pdf" "21","Gattex","1110","12/18/2018","4080","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","1110","12/18/2018","4081","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","1110","12/18/2018","4082","What You Need to Know About Gattex Treatment: A Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_What_You_Need_to_Know_About_Gattex_Treatment_A_Patient_and_Caregiver_Counseling_Guide.pdf" "21","Gattex","1110","12/18/2018","4083","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Document.pdf" "21","Gattex","1110","12/18/2018","4084","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Full.pdf" "385","Ultomiris","1111","12/21/2018","4085","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Full.pdf" "385","Ultomiris","1111","12/21/2018","4086","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Document.pdf" "385","Ultomiris","1111","12/21/2018","4087","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Patient_Safety_Card.pdf" "385","Ultomiris","1111","12/21/2018","4088","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Patient_Safety_Brochure.pdf" "385","Ultomiris","1111","12/21/2018","4089","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1111","12/21/2018","4090","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1111","12/21/2018","4091","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Program_Website_Screenshots.pdf" "351","Clozapine","1113","01/16/2019","4092","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_REMS_Full.pdf" "351","Clozapine","1113","01/16/2019","4093","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_REMS_Document.pdf" "351","Clozapine","1113","01/16/2019","4094","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4095","Prescriber Designee Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Prescriber_Designee_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4096","Knowledge Assessment for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Knowledge_Assessment_for_Healthcare_Providers.pdf" "351","Clozapine","1113","01/16/2019","4097","Clozapine and the Risk of Neutropenia A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1113","01/16/2019","4098","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_ANC_Lab_Reporting_Form.pdf" "351","Clozapine","1113","01/16/2019","4099","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Patient_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4100","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Outpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4101","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4102","Chain Headquarters Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_Chain_Headquarters_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1113","01/16/2019","4103","A Guide for Patients and Caregivers What You Need to Know About Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_A_Guide_for_Patients_and_Caregivers_What_You_Need_to_Know_about_Clozapine_and-Neutropenia.pdf" "351","Clozapine","1113","01/16/2019","4104","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_01_16_REMS_Program_Website_Screenshots.pdf" "76","Opsumit","1114","02/01/2019","4105","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Change_in_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "76","Opsumit","1114","02/01/2019","4106","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Guide_for_Female_Patients.pdf" "76","Opsumit","1114","02/01/2019","4107","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","1114","02/01/2019","4108","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","1114","02/01/2019","4109","Patient Enrollment and Consent Form for VA Use Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Patient_Enrollment_and_Consent_Form_for_VA_use_only.pdf" "76","Opsumit","1114","02/01/2019","4110","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","1114","02/01/2019","4111","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","1114","02/01/2019","4112","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_REMS_Document.pdf" "76","Opsumit","1114","02/01/2019","4113","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_REMS_Full.pdf" "76","Opsumit","1114","02/01/2019","4114","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_02_01_REMS_Program_Website_Screenshots.pdf" "341","Blincyto","1115","02/05/2019","4115","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_REMS_Full.pdf" "341","Blincyto","1115","02/05/2019","4116","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_REMS_Document.pdf" "341","Blincyto","1115","02/05/2019","4117","Letter for Hospital and Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_Letter-for_Hospital_and_Home_Healthcare_Pharmacists.pdf" "341","Blincyto","1115","02/05/2019","4118","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_Letter_for_Professional_Societies.pdf" "341","Blincyto","1115","02/05/2019","4119","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_Letter_for_Healthcare_Providers.pdf" "341","Blincyto","1115","02/05/2019","4120","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bllincyto_2019_02_05_Fact_Sheet.pdf" "341","Blincyto","1115","02/05/2019","4121","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2019_02_05_REMS_Website_Screenshots.pdf" "386","Spravato","1117","03/05/2019","4122","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_REMS_Program_Website_Screenshots.pdf" "386","Spravato","1117","03/05/2019","4123","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_Fact_Sheet.pdf" "386","Spravato","1117","03/05/2019","4124","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_REMS_Letter_for_Healthcare_Providers.pdf" "386","Spravato","1117","03/05/2019","4125","Patient Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_Patient_Monitoring_Form.pdf" "386","Spravato","1117","03/05/2019","4126","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_Patient_Enrollment_Form.pdf" "386","Spravato","1117","03/05/2019","4127","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_Pharmacy_Enrollment_Form.pdf" "386","Spravato","1117","03/05/2019","4128","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_Healthcare_Setting_Enrollment_Form.pdf" "386","Spravato","1117","03/05/2019","4129","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_REMS_Document.pdf" "386","Spravato","1117","03/05/2019","4130","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_03_05_REMS_Full.pdf" "380","Jynarque","1118","03/04/2019","4131","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_REMS_Full.pdf" "380","Jynarque","1118","03/04/2019","4132","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_REMS_Document.pdf" "380","Jynarque","1118","03/04/2019","4133","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Program_Overview.pdf" "380","Jynarque","1118","03/04/2019","4134","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Prescriber_Training.pdf" "380","Jynarque","1118","03/04/2019","4135","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1118","03/04/2019","4136","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1118","03/04/2019","4137","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1118","03/04/2019","4138","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jyarque_2019_03_04_Patient_Enrollment_Form.pdf" "380","Jynarque","1118","03/04/2019","4139","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_04_04_Patient_Status_Form.pdf" "380","Jynarque","1118","03/04/2019","4140","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_REMS_Website_Screenshots.pdf" "380","Jynarque","1118","03/04/2019","4141","Prescriber Knowledgement Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1118","03/04/2019","4142","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Patient_Guide.pdf" "380","Jynarque","1118","03/04/2019","4143","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1118","03/04/2019","4144","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_03_04_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1119","03/19/2019","4145","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_REMS_Program_Website_Screenshots.pdf" "387","Zulresso","1119","03/19/2019","4146","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1119","03/19/2019","4147","Healthcare Setting Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1119","03/19/2019","4148","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1119","03/19/2019","4149","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Patient_Information_Guide.pdf" "387","Zulresso","1119","03/19/2019","4150","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1119","03/19/2019","4151","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Post_Infusion_Form.pdf" "387","Zulresso","1119","03/19/2019","4152","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Program_Overview_For_Pharmacies.pdf" "387","Zulresso","1119","03/19/2019","4153","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Training_For_Healthcare_Settings.pdf" "387","Zulresso","1119","03/19/2019","4154","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1119","03/19/2019","4155","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_Patient_Enrollment_Form.pdf" "387","Zulresso","1119","03/19/2019","4156","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_REMS_Document.pdf" "387","Zulresso","1119","03/19/2019","4157","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_03_19_REMS_Full.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4158","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Full.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4159","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Document.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4160","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Prescriber Enrollment and Agreement Form.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4161","Inpatient Pharmacy Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Inpateint Pharmacy Enrollment and Agreement Form.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4162","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Prescriber Guide.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4163","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Pharmacy Guide.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4164","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Patient Enrollment and Consent Form.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4165","Change in Reproductive Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Change in Reproductive Status and Pre-Pubertal Annual Verification Form.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4166","Outpatient Pharmacy Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Outpateint Pharmacy Enrollment and Agreement Form.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4167","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Website Screenshots.pdf" "388","PS-Ambrisentan","1120","03/28/2019","4168","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Guide for Female Patients.pdf" "350","Addyi","1122","04/02/2019","4179","REMS Program Distributor Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Distributor_Enrollment_Form.pdf" "350","Addyi","1122","04/02/2019","4180","REMS Program Individual Location Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Individual_Location_Outpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1122","04/02/2019","4181","REMS Program Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Inpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1122","04/02/2019","4182","REMS Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Knowledge_Assessment.pdf" "350","Addyi","1122","04/02/2019","4183","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Website_Screenshots.pdf" "350","Addyi","1122","04/02/2019","4184","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Document.pdf" "350","Addyi","1122","04/02/2019","4185","REMS Program Multiple Locations Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Multiple_Locations_Outpatient_Pharmacy_Enrollment_Form.pdf" "350","Addyi","1122","04/02/2019","4186","REMS Program Patient-Provider Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Patient_Provider_Agreement_Form.pdf" "350","Addyi","1122","04/02/2019","4187","REMS Program Prescriber and Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Prescriber_and_Pharmacy_Training.pdf" "350","Addyi","1122","04/02/2019","4188","REMS Program Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Program_Prescriber_Enrollment_Form.pdf" "350","Addyi","1122","04/02/2019","4189","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_04_02_REMS_Full.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4190","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_REMS_Program_Website_Screenshots.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4191","Post-Injection Delirium/Sedation Syndrome Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Post_Injection_Delirium_Sedation_Syndrome_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4192","Multiple Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Multiple_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4193","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Single_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4194","Reconstitution and Administration Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Reconstitution_and_Administration_Training.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4195","Buy & Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Buy_and_Bill_Pharmacy_Service_Provider_Registration_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4196","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Patient_Registration_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4197","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Healthcare_Facility_Registration_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4198","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Pharmacy_Registration_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4199","Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Patient_Care_Program_Instructions_Brochure.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4200","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Prescriber_Registration_Form.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4201","Healthcare Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_Healthcare_Professional_Training.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4202","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_REMS_Document.pdf" "74","Zyprexa Relprevv","1124","04/11/2019","4203","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2019_04_11_REMS_Full.pdf" "390","Mifepristone","1126","04/11/2019","4204","Patient Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Patient_Agreement_Form.pdf" "390","Mifepristone","1126","04/11/2019","4205","Prescriber Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Prescriber_Agreement_Form_for_GenBioPro_Inc.pdf" "390","Mifepristone","1126","04/11/2019","4206","Prescriber Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Prescriber_Agreement_Form_for_Danco_Laboratories_LLC.pdf" "390","Mifepristone","1126","04/11/2019","4207","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Document.pdf" "390","Mifepristone","1126","04/11/2019","4208","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf" "391","testosterone (ANDA 208620)","1127","04/10/2019","4209","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 208620 REMS Full.pdf" "391","testosterone (ANDA 208620)","1127","04/10/2019","4210","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 208620 REMS Documentpdf.pdf" "392","testosterone (ANDA 208560)","1128","04/10/2019","4211","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 208560 REMS Full.pdf" "392","testosterone (ANDA 208560)","1128","04/10/2019","4212","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 208560 REMS Document.pdf" "393","testosterone (ANDA 207373)","1129","04/10/2019","4213","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 207373 REMS Full.pdf" "393","testosterone (ANDA 207373)","1129","04/10/2019","4214","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 207373 REMS Document.pdf" "394","testosterone (ANDA 204570)","1130","04/10/2019","4215","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 204570 REMS Full.pdf" "394","testosterone (ANDA 204570)","1130","04/10/2019","4216","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone ANDA 204570 REMS Document.pdf" "341","Blincyto","1131","04/18/2019","4217","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 REMS Full.pdf" "341","Blincyto","1131","04/18/2019","4218","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 REMS Document.pdf" "341","Blincyto","1131","04/18/2019","4219","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 Letter for Healthcare Providers.pdf" "341","Blincyto","1131","04/18/2019","4220","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 Letter for Professional Societies.pdf" "341","Blincyto","1131","04/18/2019","4221","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 Letter for Hospital and Home Healthcare Pharmacists.pdf" "341","Blincyto","1131","04/18/2019","4222","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 Fact Sheet.pdf" "341","Blincyto","1131","04/18/2019","4223","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 04 18 REMS Website Screenshots.pdf" "340","Lemtrada","1132","04/23/2019","4224","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada 2019 04 23 REMS Full.pdf" "340","Lemtrada","1132","04/23/2019","4225","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019 _04_23_REMS_Document.pdf" "340","Lemtrada","1132","04/23/2019","4226","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1132","04/23/2019","4227","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Patient_Enrollment_Form.pdf" "340","Lemtrada","1132","04/23/2019","4228","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1132","04/23/2019","4229","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1132","04/23/2019","4230","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_REMS_Program_Overview.pdf" "340","Lemtrada","1132","04/23/2019","4231","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Education_Program_for_Prescribers.pdf" "340","Lemtrada","1132","04/23/2019","4232","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Knowledge_Assessment.pdf" "340","Lemtrada","1132","04/23/2019","4233","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Education_Program_for_Healthcare_Facilities.pdf" "340","Lemtrada","1132","04/23/2019","4234","What You Need to Know About Lemtrada Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_What_You_Need_to_Know_About_Lemtrada_Treatment_A_Patient_Guide.pdf" "340","Lemtrada","1132","04/23/2019","4235","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1132","04/23/2019","4236","What You Need to Know About Lemtrada Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_What_You_Need_to_Know_About_Lemtrada_Treatment_and_Infusion_Reactions_A_Patient_Guide.pdf" "340","Lemtrada","1132","04/23/2019","4237","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Patient_Authorization_and_Baseline_Lab_Form.pdf" "340","Lemtrada","1132","04/23/2019","4238","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Prescription_Ordering_Form.pdf" "340","Lemtrada","1132","04/23/2019","4239","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Patient_Status_Form.pdf" "340","Lemtrada","1132","04/23/2019","4240","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Infusion_Checklist .pdf" "340","Lemtrada","1132","04/23/2019","4241","REMS Letter 1 for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_REMS_Letter_1_for_Healthcare_Providers .pdf" "340","Lemtrada","1132","04/23/2019","4242","REMS Letter 2 for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_REMS_Letter_2_for_Healthcare_Providers.pdf" "340","Lemtrada","1132","04/23/2019","4243","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_REMS_Website_Screenshots.pdf" "340","Lemtrada","1132","04/23/2019","4244","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrtrada_2019_04_23_Patient_Status_Reminder_Letter.pdf" "340","Lemtrada","1132","04/23/2019","4245","Patient Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_04_23_Patient_Reminder_Letter.pdf" "395","Bosentan","1134","04/26/2019","4246","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Pharmacy_Guide.pdf" "395","Bosentan","1134","04/26/2019","4247","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Inpatient_Pharmacy_Enrollment_Form.pdf" "395","Bosentan","1134","04/26/2019","4248","Chain Pharmacy Headquarters Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Chain_Pharmacy_Headquarters_Enrollment_Form.pdf" "395","Bosentan","1134","04/26/2019","4249","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Outpatient_Pharmacy_Enrollment_Form.pdf" "395","Bosentan","1134","04/26/2019","4250","Bosentan REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Bosentan_REMS_Program_Website_Screenshots.pdf" "395","Bosentan","1134","04/26/2019","4251","Testing and Patient Counseling Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Testing_and_Patient_Counseling_Reporting_Form.pdf" "395","Bosentan","1134","04/26/2019","4252","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Fact_Sheet.pdf" "395","Bosentan","1134","04/26/2019","4253","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Change_in_Reproductive_Potential_Status_and_Prepubertal_Annual_Verification_Form.pdf" "395","Bosentan","1134","04/26/2019","4254","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Guide_for_Patients.pdf" "395","Bosentan","1134","04/26/2019","4255","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Patient_Enrollment_Form.pdf" "395","Bosentan","1134","04/26/2019","4256","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Prescriber_Enrollment_Form.pdf" "395","Bosentan","1134","04/26/2019","4257","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_Prescriber_Guide.pdf" "395","Bosentan","1134","04/26/2019","4258","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_REMS_Document.pdf" "395","Bosentan","1134","04/26/2019","4259","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2019_04_26_REMS_Full.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4260","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Full.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4261","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Document.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4262","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019-04_19_Knowledge Assessment.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4263","Live Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_04-19 Live Training.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4264","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 Hospital Enrollment Form.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4265","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_04_19_Adverse Reaction Management Guide.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4266","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 REMS Website Screenshots.pdf" "375","Yescarta and Tecartus","1135","04/19/2019","4267","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta 2019 04 19 Patient Wallet Card.pdf" "149","Adempas","1136","05/08/2019","4268","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 REMS Full.pdf" "149","Adempas","1136","05/08/2019","4269","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 REMS Document.pdf" "149","Adempas","1136","05/08/2019","4270","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Prescriber Enrollment and Agreement Form.pdf" "149","Adempas","1136","05/08/2019","4271","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Patient Enrollment and Consent Form.pdf" "149","Adempas","1136","05/08/2019","4272","Inpatient Pharmacy Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Inpatient Pharmacy Enrollment Form.pdf" "149","Adempas","1136","05/08/2019","4273","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.pdf" "149","Adempas","1136","05/08/2019","4274","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Prescriber and Pharmacy Guide .pdf" "149","Adempas","1136","05/08/2019","4275","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 REMS Program Website Screenshots.pdf" "149","Adempas","1136","05/08/2019","4276","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 08 Guide for Female Patients.pdf" "341","Blincyto","1137","05/16/2019","4277","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Full.pdf" "341","Blincyto","1137","05/16/2019","4278","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Document.pdf" "341","Blincyto","1137","05/16/2019","4279","Letter for Hospital and Homecare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Hospital and Homecare Pharmacists.pdf" "341","Blincyto","1137","05/16/2019","4280","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Healthcare Providers.pdf" "341","Blincyto","1137","05/16/2019","4281","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Professional Societies.pdf" "341","Blincyto","1137","05/16/2019","4282","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Fact Sheet.pdf" "341","Blincyto","1137","05/16/2019","4283","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Website Screenshots.pdf" "387","Zulresso","1138","05/17/2019","4297","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Program_Website_Screenshots.pdf" "387","Zulresso","1138","05/17/2019","4298","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1138","05/17/2019","4299","Healthcare Setting Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1138","05/17/2019","4300","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1138","05/17/2019","4301","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Patient_Information_Guide.pdf" "387","Zulresso","1138","05/17/2019","4302","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Post_Infusion_Form.pdf" "387","Zulresso","1138","05/17/2019","4303","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Program_Overview.pdf" "387","Zulresso","1138","05/17/2019","4304","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1138","05/17/2019","4305","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Patient_Enrollment_Form.pdf" "387","Zulresso","1138","05/17/2019","4306","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1138","05/17/2019","4307","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Document.pdf" "387","Zulresso","1138","05/17/2019","4308","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1138","05/17/2019","4309","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Full.pdf" "46","Revlimid","1139","05/28/2019","4310","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Full.pdf" "46","Revlimid","1139","05/28/2019","4311","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Document.pdf" "46","Revlimid","1139","05/28/2019","4312","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Prescriber Enrollment Form.pdf" "46","Revlimid","1139","05/28/2019","4313","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimd 2019 05 28 Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant.pdf" "46","Revlimid","1139","05/28/2019","4314","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimd 2019 05 28 Patient Physician Agreement Form for Female Child Who Can Get Pregnant.pdf" "46","Revlimid","1139","05/28/2019","4315","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Physician Agreement Form for Adult Female Who Can Not Get Pregnant.pdf" "46","Revlimid","1139","05/28/2019","4316","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Physician Agreement Form for Female Child Who Can Not Get Pregnant.pdf" "46","Revlimid","1139","05/28/2019","4317","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Physician Agreement Form for Adult Male.pdf" "46","Revlimid","1139","05/28/2019","4318","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Physician Agreement Form for Male Child.pdf" "46","Revlimid","1139","05/28/2019","4319","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Education and Prescribing Safety Kit.pdf" "46","Revlimid","1139","05/28/2019","4321","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Welcome Letter.pdf" "46","Revlimid","1139","05/28/2019","4322","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Prescriber Guide.pdf" "46","Revlimid","1139","05/28/2019","4323","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Pharmacy Guide.pdf" "46","Revlimid","1139","05/28/2019","4324","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Program Pharmacy Training.pdf" "46","Revlimid","1139","05/28/2019","4325","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Pharmacy Certification Quiz.pdf" "46","Revlimid","1139","05/28/2019","4326","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Guide.pdf" "46","Revlimid","1139","05/28/2019","4327","Patient Resource Pack","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Resource Pack.pdf" "46","Revlimid","1139","05/28/2019","4328","Emergency Contraception Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Emergency Contraception Guide.pdf" "46","Revlimid","1139","05/28/2019","4329","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Education and Counseling Checklist for Pharmacies.pdf" "46","Revlimid","1139","05/28/2019","4330","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Celgene Risk Management Website Screenshots.pdf" "395","Bosentan","1161","05/20/2019","4331","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 REMS Full.pdf" "395","Bosentan","1161","05/20/2019","4332","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 REMS Document.pdf" "395","Bosentan","1161","05/20/2019","4333","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Prescriber Guide.pdf" "395","Bosentan","1161","05/20/2019","4334","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Prescriber Enrollment Form.pdf" "395","Bosentan","1161","05/20/2019","4335","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Patient Enrollment Form.pdf" "395","Bosentan","1161","05/20/2019","4336","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Guide for Patients.pdf" "395","Bosentan","1161","05/20/2019","4337","Change in Reproductive Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Change in Reproductive Status and Pre-pubertal Annual Verification Form.pdf" "395","Bosentan","1161","05/20/2019","4338","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Fact Sheet.pdf" "395","Bosentan","1161","05/20/2019","4339","Testing and Patient Counseling Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Testing and Patient Counseling Reporting Form.pdf" "395","Bosentan","1161","05/20/2019","4340","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 REMS Website Screenshots.pdf" "395","Bosentan","1161","05/20/2019","4341","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Pharmacy Guide.pdf" "395","Bosentan","1161","05/20/2019","4342","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Outpatient Pharmacy Enrollment Form.pdf" "395","Bosentan","1161","05/20/2019","4343","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Inpatient Pharmacy Enrollment Form.pdf" "395","Bosentan","1161","05/20/2019","4344","Chain Pharmacy Headquarters Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan 2019 05 20 Chain Pharmacy Headquarters Enrollment Form.pdf" "364","Vigabatrin","1162","05/30/2019","4345","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 39 REMS Full.pdf" "364","Vigabatrin","1162","05/30/2019","4346","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 REMS Document.pdf" "364","Vigabatrin","1162","05/30/2019","4347","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Prescriber Enrollment and Agreement Form.pdf" "364","Vigabatrin","1162","05/30/2019","4348","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Patient Guide.pdf" "364","Vigabatrin","1162","05/30/2019","4349","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Pharmacy Enrollment Form.pdf" "364","Vigabatrin","1162","05/30/2019","4350","Patient/Parent/Legal Guardian -Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Patient Parent Legal Guardian Physician Agreement Form.pdf" "364","Vigabatrin","1162","05/30/2019","4351","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 REMS Website Screenshots.pdf" "149","Adempas","1163","05/30/2019","4352","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 REMS Full.pdf" "149","Adempas","1163","05/30/2019","4353","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 50 30 REMS Document.pdf" "149","Adempas","1163","05/30/2019","4354","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 REMS Website Screenshots.pdf" "149","Adempas","1163","05/30/2019","4355","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Prescriber Enrollment and Agreement Form.pdf" "149","Adempas","1163","05/30/2019","4356","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Prescriber and Pharmacy Guide.pdf" "149","Adempas","1163","05/30/2019","4357","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Patient Enrollment and Consent Form.pdf" "149","Adempas","1163","05/30/2019","4358","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Inpatient Pharmacy Enrollment Form.pdf" "149","Adempas","1163","05/30/2019","4359","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Guide for Female Patients.pdf" "149","Adempas","1163","05/30/2019","4360","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas 2019 05 30 Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.pdf" "21","Gattex","1164","05/16/2019","4361","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_REMS_Program_Website_Screenshots.pdf" "21","Gattex","1164","05/16/2019","4362","Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_Patient_and_Caregiver_Counseling_Guide.pdf" "21","Gattex","1164","05/16/2019","4363","Post Training Knowledge Assessment Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_Post_Training_Knowledge_Assessment_Questions.pdf" "21","Gattex","1164","05/16/2019","4364","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","1164","05/16/2019","4365","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","1164","05/16/2019","4366","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_REMS_Document.pdf" "21","Gattex","1164","05/16/2019","4367","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2019_05_16_REMS_Full.pdf" "76","Opsumit","1165","06/10/2019","4368","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_REMS_Program_Website_Screenshots.pdf" "76","Opsumit","1165","06/10/2019","4369","Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Change_in_Reproductive_Potential_Status_and_Pre_Pubertal_Annual_Verification_Form.pdf" "76","Opsumit","1165","06/10/2019","4370","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Guide_for_Female_Patients.pdf" "76","Opsumit","1165","06/10/2019","4371","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","1165","06/10/2019","4372","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","1165","06/10/2019","4373","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","1165","06/10/2019","4374","Patient Enrollment and Consent Form for VA Use Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Patient_Enrollment_and_Consent_Form_for_VA_use_only.pdf" "76","Opsumit","1165","06/10/2019","4375","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","1165","06/10/2019","4376","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_REMS_Document.pdf" "76","Opsumit","1165","06/10/2019","4377","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2019_06_10_REMS_Full.pdf" "67","Vivitrol","1166","06/07/2019","4378","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Full.pdf" "67","Vivitrol","1166","06/07/2019","4379","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Document.pdf" "67","Vivitrol","1166","06/07/2019","4380","Dear Healthcare Provider (DHCP) Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Dear Healthcare Provider DHCP Letter.pdf" "67","Vivitrol","1166","06/07/2019","4381","Patient Counseling Tool","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Patient Counseling Tool.pdf" "67","Vivitrol","1166","06/07/2019","4382","Key Techniques to Reduce Severe Injection Site Reactions Poster","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Key Techniques to Reduce Severe Injection Site Reactions Poster.pdf" "67","Vivitrol","1166","06/07/2019","4383","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Website Screenshot.pdf" "25","Juxtapid","1168","06/13/2019","4384","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 REMS Full.pdf" "25","Juxtapid","1168","06/13/2019","4385","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 REMS Document.pdf" "25","Juxtapid","1168","06/13/2019","4386","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Prescriber Training Module and Knowledge Assessment.pdf" "25","Juxtapid","1168","06/13/2019","4387","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Prescriber Enrollment Form.pdf" "25","Juxtapid","1168","06/13/2019","4388","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Fact Sheet.pdf" "25","Juxtapid","1168","06/13/2019","4389","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Prescription Authorization Form.pdf" "25","Juxtapid","1168","06/13/2019","4390","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Patient Prescriber Acknowledgement Form.pdf" "25","Juxtapid","1168","06/13/2019","4391","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Patient Guide.pdf" "25","Juxtapid","1168","06/13/2019","4392","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Letter for Healthcare Providers.pdf" "25","Juxtapid","1168","06/13/2019","4393","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Letter for Pharmacists.pdf" "25","Juxtapid","1168","06/13/2019","4394","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Pharmacy Enrollment Form.pdf" "25","Juxtapid","1168","06/13/2019","4395","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 Pharmacy Training Module and Knowledge Assessment.pdf" "25","Juxtapid","1168","06/13/2019","4396","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid 2019 06 13 REMS Program Website Screenshots.pdf" "387","Zulresso","1169","06/17/2019","4397","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 REMS Full.pdf" "387","Zulresso","1169","06/17/2019","4398","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 REMS Document.pdf" "387","Zulresso","1169","06/17/2019","4399","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Training for Healthcare Settings.pdf" "387","Zulresso","1169","06/17/2019","4400","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Program Overview.pdf" "387","Zulresso","1169","06/17/2019","4401","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Post Infusion Form.pdf" "387","Zulresso","1169","06/17/2019","4402","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Pharmacy Enrollment Form.pdf" "387","Zulresso","1169","06/17/2019","4403","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Patient Information Guide.pdf" "387","Zulresso","1169","06/17/2019","4404","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Patient Enrollment Form.pdf" "387","Zulresso","1169","06/17/2019","4405","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Letter for Healthcare Providers.pdf" "387","Zulresso","1169","06/17/2019","4406","Healthcare Setting Knowledge Assessment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Healthcare Setting Knowledge Assessment Form.pdf" "387","Zulresso","1169","06/17/2019","4407","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Healthcare Setting Enrollment Form.pdf" "387","Zulresso","1169","06/17/2019","4408","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 Excessive Sedation and Loss of Consciousness Adverse Event Form.pdf" "387","Zulresso","1169","06/17/2019","4409","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso 2019 06 17 REMS Program Website Screenshots.pdf" "386","Spravato","1170","06/25/2019","4410","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Full.pdf" "386","Spravato","1170","06/25/2019","4411","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Program_Website_Screenshots.pdf" "386","Spravato","1170","06/25/2019","4412","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Fact_Sheet.pdf" "386","Spravato","1170","06/25/2019","4413","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Healthcare_Setting_Enrollment_Form.pdf" "386","Spravato","1170","06/25/2019","4414","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Letter_for_Healthcare_Providers.pdf" "386","Spravato","1170","06/25/2019","4415","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Patient_Enrollment_Form.pdf" "386","Spravato","1170","06/25/2019","4416","Patient Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Patient_Monitoring_Form.pdf" "386","Spravato","1170","06/25/2019","4417","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Pharmacy_Enrollment_Form.pdf" "386","Spravato","1170","06/25/2019","4418","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Document.pdf" "362","Siliq","1171","06/27/2019","4419","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_REMS_Full.pdf" "362","Siliq","1171","06/27/2019","4420","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_REMS_Document.pdf" "362","Siliq","1171","06/27/2019","4421","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_Patient_Wallet_Card.pdf" "362","Siliq","1171","06/27/2019","4422","Patient-Prescriber Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_Patient_Precriber_Agreement_Form.pdf" "362","Siliq","1171","06/27/2019","4423","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1171","06/27/2019","4424","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06_27_REMS_Website_Screenshots.pdf" "362","Siliq","1171","06/27/2019","4425","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_06-27_Prescriber_Enrollment_Form.pdf" "368","Kymriah","1173","06/20/2019","4426","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Full.pdf" "368","Kymriah","1173","06/20/2019","4427","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Document.pdf" "368","Kymriah","1173","06/20/2019","4428","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Hospital_Enrollment_Form.pdf" "368","Kymriah","1173","06/20/2019","4429","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Patient_Wallet_Card.pdf" "368","Kymriah","1173","06/20/2019","4430","Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Program_Knowledge_Assessment.pdf" "368","Kymriah","1173","06/20/2019","4431","Live Training Program Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_Live_Training_Program_Slides.pdf" "368","Kymriah","1173","06/20/2019","4432","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2019_06_20_REMS_Program_Website_Screenshots.pdf" "389","Turalio","1174","08/02/2019","4433","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_REMS_Full.pdf" "389","Turalio","1174","08/02/2019","4434","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_REMS_Document.pdf" "389","Turalio","1174","08/02/2019","4435","Prescriber Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Prescriber_Enrollment_Form.pdf" "389","Turalio","1174","08/02/2019","4436","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Program_Overview.pdf" "389","Turalio","1174","08/02/2019","4437","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Pharmacy_Enrollment_Form.pdf" "389","Turalio","1174","08/02/2019","4438","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Patient_Enrollment_Form.pdf" "389","Turalio","1174","08/02/2019","4439","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Prescriber_Training.pdf" "389","Turalio","1174","08/02/2019","4440","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1174","08/02/2019","4441","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Patient_Status_Form.pdf" "389","Turalio","1174","08/02/2019","4442","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Patient_Guide.pdf" "389","Turalio","1174","08/02/2019","4443","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1174","08/02/2019","4444","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1174","08/02/2019","4445","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_REMS_Website_Screenshots.pdf" "389","Turalio","1174","08/02/2019","4446","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_02_Letter_for_Professional_Societies.pdf" "360","Alosetron","1175","08/05/2019","4447","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Program_Website_Screenshots.pdf" "360","Alosetron","1175","08/05/2019","4449","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form.pdf" "360","Alosetron","1175","08/05/2019","4450","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Patient_Education_Sheet.pdf" "360","Alosetron","1175","08/05/2019","4451","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "360","Alosetron","1175","08/05/2019","4452","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Prescriber_Education_Slide_Deck.pdf" "360","Alosetron","1175","08/05/2019","4453","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Document.pdf" "360","Alosetron","1175","08/05/2019","4454","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Full.pdf" "360","Alosetron","1175","08/05/2019","4455","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Letter_to_Healthcare_Providers.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4456","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28 REMS_Full.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4457","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28_REMS_Document.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4458","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_ System_2019_Prescriber_Enrollment_and_Agreement_Form.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4459","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared _System_2019_03_28_Prescriber_and_Pharmacy_Guide.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4462","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28_Outpatient_Pharmacy_Enrollment_Form.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4463","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28 _Inpatient_Pharmacy_Enrollment_Form.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4464","Change in Reproductive Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_Syste_ 2019_03_28_Change_in_Reproductive_Potential_Status_and_PrePubertal_Annual_Verification_Form.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4465","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28_Guide_for_Female_Patients.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4466","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_Syste_ 2019_03_28_Patient_Enrollment _and_Consent_Form.pdf" "396","Ambrisentan Shared System","1178","03/28/2019","4467","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2019_03_28_Website_Screenshots.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4468","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4469","Patient Wallet Cards","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_Patient_Wallet_Cards.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4470","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_REMS_Program_Website_Screenshots.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4471","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4472","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4473","Live Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_Live_Training.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4474","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_REMS_Document.pdf" "375","Yescarta and Tecartus","1180","08/02/2019","4475","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_08_02_REMS_Full.pdf" "389","Turalio","1181","08/20/2019","4476","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1181","08/20/2019","4477","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Letter_for_Professional_Societies.pdf" "389","Turalio","1181","08/20/2019","4478","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1181","08/20/2019","4479","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Status_Form.pdf" "389","Turalio","1181","08/20/2019","4480","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Program_Website_Screenshots.pdf" "389","Turalio","1181","08/20/2019","4481","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Enrollment_Form.pdf" "389","Turalio","1181","08/20/2019","4482","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Guide.pdf" "389","Turalio","1181","08/20/2019","4483","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Pharmacy_Enrollment_Form.pdf" "389","Turalio","1181","08/20/2019","4484","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Enrollment_Form.pdf" "389","Turalio","1181","08/20/2019","4485","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1181","08/20/2019","4486","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Training.pdf" "389","Turalio","1181","08/20/2019","4487","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Program_Overview.pdf" "389","Turalio","1181","08/20/2019","4488","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Document.pdf" "389","Turalio","1181","08/20/2019","4489","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Full.pdf" "364","Vigabatrin","1182","09/12/2019","4490","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigatbatrin_2019_09_12_REMS_Full.pdf" "364","Vigabatrin","1182","09/12/2019","4491","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_REMS_Document.pdf" "364","Vigabatrin","1182","09/12/2019","4492","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_Prescriber_Enrollment_and_Agreement_Form.pdf" "364","Vigabatrin","1182","09/12/2019","4493","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","1182","09/12/2019","4494","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "364","Vigabatrin","1182","09/12/2019","4495","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_Patient_Guide.pdf" "364","Vigabatrin","1182","09/12/2019","4496","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2019_09_12_REMS_Website_Screenshots.pdf" "49","Soliris","1183","06/27/2019","4497","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Full.pdf" "49","Soliris","1183","06/27/2019","4498","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Document.pdf" "49","Soliris","1183","06/27/2019","4499","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Prescriber_Enrollment_Form.pdf" "49","Soliris","1183","06/27/2019","4500","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Prescriber_Safety_Brochure.pdf" "49","Soliris","1183","06/27/2019","4501","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Patient_Safety_Card.pdf" "49","Soliris","1183","06/27/2019","4502","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Patient_Safety_Brochure.pdf" "49","Soliris","1183","06/27/2019","4503","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Website_Screenshots.pdf" "387","Zulresso","1184","09/30/2019","4504","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_REMS_Program_Website_Screenshots.pdf" "387","Zulresso","1184","09/30/2019","4506","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Letter_For_Healthcare_Providers.pdf" "387","Zulresso","1184","09/30/2019","4507","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1184","09/30/2019","4508","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Post_Infusion_Form.pdf" "387","Zulresso","1184","09/30/2019","4509","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Program_Overview.pdf" "387","Zulresso","1184","09/30/2019","4510","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Patient_Information_Guide.pdf" "387","Zulresso","1184","09/30/2019","4511","Healthcare Setting Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1184","09/30/2019","4512","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1184","09/30/2019","4513","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1184","09/30/2019","4514","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Patient_Enrollment_Form.pdf" "387","Zulresso","1184","09/30/2019","4515","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1184","09/30/2019","4516","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_REMS_Document.pdf" "387","Zulresso","1184","09/30/2019","4517","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_09_30_REMS_Full.pdf" "350","Addyi","1185","10/09/2019","4518","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_10_09_REMS_Document.pdf" "350","Addyi","1185","10/09/2019","4519","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_10_09_Medication_Guide.pdf" "385","Ultomiris","1186","10/18/2019","4520","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_Patient_Safety_Brochure.pdf" "385","Ultomiris","1186","10/18/2019","4521","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_Patient_Safety_Card.pdf" "385","Ultomiris","1186","10/18/2019","4522","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1186","10/18/2019","4523","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1186","10/18/2019","4524","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_REMS_Document.pdf" "385","Ultomiris","1186","10/18/2019","4525","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_REMS_Program_Website_Screenshots.pdf" "385","Ultomiris","1186","10/18/2019","4526","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2019_10_18_REMS_Full.pdf" "340","Lemtrada","1187","10/29/2019","4527","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Full.pdf" "340","Lemtrada","1187","10/29/2019","4528","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Document.pdf" "340","Lemtrada","1187","10/29/2019","4529","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1187","10/29/2019","4530","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1187","10/29/2019","4531","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Enrollment_Form.pdf" "340","Lemtrada","1187","10/29/2019","4532","What You Need to Know About Lemtrada Treatment and Infusion Reactions: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_What_You_Need-to_Know_About_Lemtrada_Treatment_and_Infusion_Reactions_A_Patient_Guide.pdf" "340","Lemtrada","1187","10/29/2019","4533","What You Need to Know About Lemtrada Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_What_You_Need-to_Know_About_Lemtrada_Treatment_A_Patient_Guide.pdf" "340","Lemtrada","1187","10/29/2019","4534","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Program_Overview.pdf" "340","Lemtrada","1187","10/29/2019","4535","REMS Letter 1 for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Letter_1_for_Healthcare_Provider.pdf" "340","Lemtrada","1187","10/29/2019","4536","REMS Letter 2 for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Letter_2_for_Healthcare_Provider.pdf" "340","Lemtrada","1187","10/29/2019","4537","Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Prescription_Ordering_Form.pdf" "340","Lemtrada","1187","10/29/2019","4538","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Status_Form.pdf" "340","Lemtrada","1187","10/29/2019","4539","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1187","10/29/2019","4540","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Authorization_and_Baseline_Lab_Form.pdf" "340","Lemtrada","1187","10/29/2019","4541","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Knowledge_Assessment.pdf" "340","Lemtrada","1187","10/29/2019","4542","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Infusion_Checklist.pdf" "340","Lemtrada","1187","10/29/2019","4543","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1187","10/29/2019","4544","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Education_Program_for_Prescribers.pdf" "340","Lemtrada","1187","10/29/2019","4545","Education Program for Healthcare Facilities","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Education_Program_for_Healthcare_Facilities.pdf" "340","Lemtrada","1187","10/29/2019","4546","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Website_Screenshots.pdf" "340","Lemtrada","1187","10/29/2019","4547","Patient Status Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Status_Reminder_Letter.pdf" "340","Lemtrada","1187","10/29/2019","4548","Patient Reminder Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Reminder_Letter.pdf" "376","Sublocade","1188","11/07/2019","4549","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_REMS_Full.pdf" "376","Sublocade","1188","11/07/2019","4550","REMs Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_REMS_Document.pdf" "376","Sublocade","1188","11/07/2019","4551","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1188","11/07/2019","4552","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_Fact_Sheet.pdf" "376","Sublocade","1188","11/07/2019","4553","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_Healthcare_Provider_Letter.pdf" "376","Sublocade","1188","11/07/2019","4554","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2019_11_07_Website_Screenshot.pdf" "351","Clozapine","1189","11/12/2019","4555","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_REMS_Program_Website_Screenshots.pdf" "351","Clozapine","1189","11/12/2019","4556","A Guide for Patients and Caregivers: What You Need to Know about Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_A_Guide_for_Patients_and_Caregivers_What_You_Need_to_Know_about_Clozapine_and_Neutropenia.pdf" "351","Clozapine","1189","11/12/2019","4557","Chain Headquarters Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Chain_Headquarters_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4558","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1189","11/12/2019","4559","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4560","Knowledge Assessment for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Knowledge_Assessment_for_Healthcare_Providers.pdf" "351","Clozapine","1189","11/12/2019","4561","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Outpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4562","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Patient_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4563","Prescriber Designee Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Prescriber_Designee_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4564","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1189","11/12/2019","4565","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_REMS_Document.pdf" "351","Clozapine","1189","11/12/2019","4566","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_REMS_Full.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4567","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4568","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_REMS_Program_Website_Screenshots.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4569","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4570","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4571","Live Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_Live_Training.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4572","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4573","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_REMS_Full.pdf" "375","Yescarta and Tecartus","1191","11/12/2019","4574","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_2019_11_12_REMS_Document.pdf" "389","Turalio","1192","11/19/2019","4575","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1192","11/19/2019","4576","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Letter_for_Professional_Societies.pdf" "389","Turalio","1192","11/19/2019","4577","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1192","11/19/2019","4578","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Patient_Guide.pdf" "389","Turalio","1192","11/19/2019","4579","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Patient_Status_Form.pdf" "389","Turalio","1192","11/19/2019","4580","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_REMS_Program_Website_Screenshots.pdf" "389","Turalio","1192","11/19/2019","4581","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Patient_Enrollment_Form.pdf" "389","Turalio","1192","11/19/2019","4582","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Pharmacy_Enrollment_Form.pdf" "389","Turalio","1192","11/19/2019","4583","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Prescriber_Enrollment_Form.pdf" "389","Turalio","1192","11/19/2019","4584","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1192","11/19/2019","4585","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Prescriber_Training.pdf" "389","Turalio","1192","11/19/2019","4586","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_Program_Overview.pdf" "389","Turalio","1192","11/19/2019","4587","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_REMS_Document.pdf" "389","Turalio","1192","11/19/2019","4588","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_11_19_REMS_Full.pdf" "351","Clozapine","1189","11/12/2019","4589","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2019_11_12_ANC_Lab_Reporting_Form.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4590","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_REMS_Full.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4591","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_REMS_Document.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4592","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Patient_Counseling_Guide.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4593","FDA Blueprint","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4594","Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Healthcare_Provider-Letter_1.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4595","Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Healthcare_Provider-Letter_2.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4596","Professional Society Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Professional Society_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4597","Professional Society Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14_Professional Society_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","1193","11/14/2019","4598","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2019_11_14__REMS_Website_Screenshots.pdf" "380","Jynarque","1194","12/03/2019","4599","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_REMS_Program_Website_Screenshots.pdf" "380","Jynarque","1194","12/03/2019","4600","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Letter_for_Healthcare_Providers.pdf" "380","Jynarque","1194","12/03/2019","4601","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1194","12/03/2019","4602","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Patient_Status_Form.pdf" "380","Jynarque","1194","12/03/2019","4603","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Patient_Guide.pdf" "380","Jynarque","1194","12/03/2019","4604","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1194","12/03/2019","4605","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Prescriber_Training.pdf" "380","Jynarque","1194","12/03/2019","4606","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Program_Overview.pdf" "380","Jynarque","1194","12/03/2019","4607","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1194","12/03/2019","4608","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1194","12/03/2019","4609","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Patient_Enrollment_Form.pdf" "380","Jynarque","1194","12/03/2019","4610","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1194","12/03/2019","4611","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_REMS_Document.pdf" "380","Jynarque","1194","12/03/2019","4612","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2019_12_03_REMS_Full.pdf" "387","Zulresso","1196","12/13/2019","4613","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_REMS_Full.pdf" "387","Zulresso","1196","12/13/2019","4614","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_REMS_Document.pdf" "387","Zulresso","1196","12/13/2019","4615","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1196","12/13/2019","4616","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Patient_Enrollment_Form.pdf" "387","Zulresso","1196","12/13/2019","4617","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1196","12/13/2019","4618","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1196","12/13/2019","4619","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Program-Overview_for_Pharmacies.pdf" "387","Zulresso","1196","12/13/2019","4620","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Patient_Information_Guide.pdf" "387","Zulresso","1196","12/13/2019","4621","Healthcare Settings Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1196","12/13/2019","4622","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Post_Infusion_Form.pdf" "387","Zulresso","1196","12/13/2019","4623","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1196","12/13/2019","4624","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1196","12/13/2019","4625","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_12_13_REMS_Website_Screenshots.pdf" "362","Siliq","1197","12/13/2019","4626","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_REMS_Program_Website_Screenshots.pdf" "362","Siliq","1197","12/13/2019","4627","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1197","12/13/2019","4628","Patient-Prescriber Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_Patient_Prescriber_Agreement_Form.pdf" "362","Siliq","1197","12/13/2019","4629","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_Patient_Wallet_Card.pdf" "362","Siliq","1197","12/13/2019","4630","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_Prescriber_Enrollment_Form.pdf" "362","Siliq","1197","12/13/2019","4631","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_REMS_Document.pdf" "362","Siliq","1197","12/13/2019","4632","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2019_12_13_REMS_Full.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4633","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_REMS_Full.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4634","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_REMS_Document.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4635","Alvimopan REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Alvimopan_REMS_Program_Overview.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4636","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Dear_Healthcare_Provider_Letter.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4637","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Hospital_Enrollment_Form.pdf" "397","Alvimopan Shared System REMS","1199","12/19/2019","4638","Prescriber and Pharmacist Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Prescriber_and_Pharmacist_Information_Brochure.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4639","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Full.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4640","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4641","The Guide to Best Practices","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_01_24_The_Guide_to_Best_Practices.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4642","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4643","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23Instructions for Managing Office Staff Designees .pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4644","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_website screenshots.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4645","Pharmacists Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacists Guide.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4646","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacy_Enrollment-form.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4647","Request for Exemption for Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Request for Exemption for Patients with Serious Medical Reasons.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4648","Wholesaler Shipment Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Shipment Request Form.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4649","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Recognizing Psychiatric Disorders in Adolescents and Young Adults.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4650","Wholesaler Agreement","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Agreement.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4651","DVDs for prescriber use in patient counseling: Be Prepared, Be Protected, and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_DVDs for prescriber use in patient counseling.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4652","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Informed Consent for Females of Reproductive Potential.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4653","Patient Information/Informed Consent for all patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Informed Consent for all patients.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4654","Guide to Isotretinoin for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Guide to Isotretinoin for Female Patients Who Can Get Pregnant.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4655","Educational Kit for Males and Females of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_01_24_Educational_Kit_for_Males_and_Females_of_Non-Reproductive_Potential.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4656","Patient Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Comprehension Questions.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4657","Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_01_24_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","1201","01/24/2020","4658","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_01_24_Office_Staff_Designee_Registration_Activation_Form.pdf" "364","Vigabatrin","1202","01/24/2020","4659","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_Patient_Guide.pdf" "364","Vigabatrin","1202","01/24/2020","4660","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf" "364","Vigabatrin","1202","01/24/2020","4661","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","1202","01/24/2020","4662","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_Prescriber_Enrollment_and_Agreement_Form.pdf" "364","Vigabatrin","1202","01/24/2020","4663","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_REMS_Document.pdf" "364","Vigabatrin","1202","01/24/2020","4664","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_REMS_Program_Website_Screenshots.pdf" "364","Vigabatrin","1202","01/24/2020","4665","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2020_01_24_REMS_Full.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4666","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4667","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4668","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4669","Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4670","Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4671","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_REMS_Document.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4672","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_REMS_Program_Website_Screenshots.pdf" "352","Suboxone/Subutex","1203","01/24/2020","4673","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_01_24_REMS_Full.pdf" "376","Sublocade","1205","01/28/2020","4674","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_REMS_Full.pdf" "376","Sublocade","1205","01/28/2020","4675","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_REMS_Document.pdf" "376","Sublocade","1205","01/28/2020","4676","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1205","01/28/2020","4677","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_Healthcare_Provider_Letter.pdf" "376","Sublocade","1205","01/28/2020","4678","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_Fact_Sheet.pdf" "376","Sublocade","1205","01/28/2020","4679","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_01_28_Website_Screenshots.pdf" "398","Palforzia","1206","01/31/2020","4680","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_REMS_Full.pdf" "398","Palforzia","1206","01/31/2020","4681","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_REMS_Document.pdf" "398","Palforzia","1206","01/31/2020","4682","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Prescriber_Enrollment_Form.pdf" "398","Palforzia","1206","01/31/2020","4683","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Patient_Enrollment_Form.pdf" "398","Palforzia","1206","01/31/2020","4684","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Healthcare_Setting_Enrollment_Form.pdf" "398","Palforzia","1206","01/31/2020","4685","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Pharmacy_Enrollment_Form.pdf" "398","Palforzia","1206","01/31/2020","4686","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Education_Program_for_Healthcare_Settings.pdf" "398","Palforzia","1206","01/31/2020","4687","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_REMS_Program_Overview_for_Pharmacies.pdf" "398","Palforzia","1206","01/31/2020","4688","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_01_31_Website_Screenshots.pdf" "149","Adempas","1207","02/10/2020","4689","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_REMS_Full.pdf" "149","Adempas","1207","02/10/2020","4690","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_REMS_Document.pdf" "149","Adempas","1207","02/10/2020","4691","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Prescriber_Enrollment_and_Agreement_Form.pdf" "149","Adempas","1207","02/10/2020","4692","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Prescriber_and_Pharmacy_Guide.pdf" "149","Adempas","1207","02/10/2020","4693","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Patient_Enrollment_and_Consent_Form.pdf" "149","Adempas","1207","02/10/2020","4694","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Inpatient_Pharmacy_Enrollment_Form.pdf" "149","Adempas","1207","02/10/2020","4695","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Guide_for_Female_Patients.pdf" "149","Adempas","1207","02/10/2020","4696","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_Change_in_Reproductive_Potential_Status_and_Prepubertal_Annual_Verification_Form.pdf" "149","Adempas","1207","02/10/2020","4697","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_02_10_REMS_Website_Screenshots.pdf" "43","Prolia","1208","04/30/2019","4698","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Full.pdf" "43","Prolia","1208","04/30/2019","4699","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Document.pdf" "43","Prolia","1208","04/30/2019","4700","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Letter_for_Healthcare_Providers.pdf" "43","Prolia","1208","04/30/2019","4701","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Letter_for_Professional_Societies.pdf" "43","Prolia","1208","04/30/2019","4702","REMS Counseling Chart for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Counseling_Chart_for_Healthcare_Providers.pdf" "43","Prolia","1208","04/30/2019","4703","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_Patient_Brochure.pdf" "43","Prolia","1208","04/30/2019","4704","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_Journal_Information_Piece.pdf" "43","Prolia","1208","04/30/2019","4705","REMS Website (landing page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_04_30_REMS_Webiste_(landing_page)_Screenshot.pdf" "43","Prolia","1209","10/01/2019","4706","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Full.pdf" "43","Prolia","1209","10/01/2019","4707","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Document.pdf" "43","Prolia","1209","10/01/2019","4708","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Letter_for_Healthcare_Providers.pdf" "43","Prolia","1209","10/01/2019","4709","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Letter_for_Professional_Societies.pdf" "43","Prolia","1209","10/01/2019","4710","Patient Counseling Chart for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Patient_Counseling_Chart_for_Healthcare_Providers.pdf" "43","Prolia","1209","10/01/2019","4711","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Patient_Brochure.pdf" "43","Prolia","1209","10/01/2019","4712","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Journal_Information_Piece.pdf" "43","Prolia","1209","10/01/2019","4713","REMS Website (landing page) Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Website_(landing_page)_Screenshot.pdf" "341","Blincyto","1210","02/14/2020","4714","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_REMS_Program_Website_Screenshots.pdf" "341","Blincyto","1210","02/14/2020","4715","Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_Fact_Sheet_for_Providers.pdf" "341","Blincyto","1210","02/14/2020","4716","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_Letter_for_Professional_Societies.pdf" "341","Blincyto","1210","02/14/2020","4717","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_Letter_for_Healthcare_Providers.pdf" "341","Blincyto","1210","02/14/2020","4718","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_Letter_for_Hospital_and_Home_Healthcare_Pharmacists.pdf" "341","Blincyto","1210","02/14/2020","4719","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_REMS_Document.pdf" "341","Blincyto","1210","02/14/2020","4720","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2020_02_14_REMS_Full.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4721","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_REMS_Full.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4722","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_REMS_Document.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4723","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4724","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4725","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4726","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4727","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1211","03/02/2020","4728","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_REMS_Website_Screenshots.pdf" "344","Farydak","1212","03/13/2020","4729","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020-03-13_REMS_Full.pdf" "344","Farydak","1212","03/13/2020","4730","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Document.pdf" "344","Farydak","1212","03/13/2020","4731","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Fact_Sheet.pdf" "344","Farydak","1212","03/13/2020","4732","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_Healthcare_Provider_Letter.pdf" "344","Farydak","795","02/23/2015","4733","Professional Societies Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_Professional_Societies_Letter.pdf" "344","Farydak","1212","03/13/2020","4734","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020-03-13_Journal_Information_Piece.pdf" "344","Farydak","1212","03/13/2020","4735","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Website_Screenshot.pdf" "314","Myalept","1213","03/13/2020","4737","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_REMS_Full.pdf" "314","Myalept","1213","03/13/2020","4738","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_REMS_Document.pdf" "314","Myalept","1213","03/13/2020","4739","Prescrbing Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_Prescriber_Training_Module.pdf" "314","Myalept","1213","03/13/2020","4740","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_Prescriber_Enrollment_Form.pdf" "314","Myalept","1213","03/13/2020","4741","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_REMS_Program_An_Introduction.pdf" "314","Myalept","1213","03/13/2020","4742","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_Website_Screenshots.pdf" "314","Myalept","1213","03/13/2020","4743","Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_Prescriber_Authorization_Form.pdf" "314","Myalept","1213","03/13/2020","4744","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_03_13_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","1214","03/13/2020","4745","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_REMS_Full.pdf" "25","Juxtapid","1214","03/13/2020","4746","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_REMS_Document.pdf" "25","Juxtapid","1214","03/13/2020","4747","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1214","03/13/2020","4748","Prescriber Training and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Prescriber_Training_and_Knowledge_Assessment.pdf" "25","Juxtapid","1214","03/13/2020","4749","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Fact_Sheet.pdf" "25","Juxtapid","1214","03/13/2020","4750","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Patient_Guide.pdf" "25","Juxtapid","1214","03/13/2020","4751","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Prescription_Authorization_Form.pdf" "25","Juxtapid","1214","03/13/2020","4752","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1214","03/13/2020","4753","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13-Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","1214","03/13/2020","4754","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1214","03/13/2020","4755","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_ Letter_for_Pharmacists .pdf" "25","Juxtapid","1214","03/13/2020","4756","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03_13_ Pharmacy_Training_Module_ and_Knowledge_Assessment.pdf" "25","Juxtapid","1214","03/13/2020","4757","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_03-13_ REMS_Program_Website_Screenshots.pdf" "49","Soliris","1215","04/07/2020","4758","Soliris REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Full.pdf" "49","Soliris","1215","04/07/2020","4759","Soliris REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Document.pdf" "49","Soliris","1215","04/07/2020","4760","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Enrollment_Form.pdf" "49","Soliris","1215","04/07/2020","4761","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient_Safety_Card.pdf" "49","Soliris","1215","04/07/2020","4762","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient Safety_Brochure.pdf" "49","Soliris","1215","04/07/2020","4763","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Safety_Brochure.pdf" "49","Soliris","1215","04/07/2020","4764","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Program_Website_Screenshots.pdf" "76","Opsumit","1216","04/08/2020","4765","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_REMS_Full.pdf" "76","Opsumit","1216","04/08/2020","4766","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_REMS_Document.pdf" "76","Opsumit","1216","04/08/2020","4767","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Prescriber_Enrollment_and_Agreement_Form.pdf" "76","Opsumit","1216","04/08/2020","4768","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020-04_08_Patient_Enrollment_and_Consent_Form.pdf" "76","Opsumit","1216","04/08/2020","4769","Patient Enrollment and Consent Form - for VA Use Only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Patient_Enrollment_and_Consent_Form_for_VA_Use_Only.pdf" "76","Opsumit","1216","04/08/2020","4770","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Inpatient_Pharmacy_Enrollment_Form.pdf" "76","Opsumit","1216","04/08/2020","4771","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Prescriber_and_Pharmacy_Guide.pdf" "76","Opsumit","1216","04/08/2020","4772","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Guide_for_Female_Patients.pdf" "76","Opsumit","1216","04/08/2020","4773","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_Change_in_Reproductive_Potential_Status_and_Prepubertal_Annual_Verification_Form.pdf" "76","Opsumit","1216","04/08/2020","4774","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opsumit_2020_04_08_REMS_Program_Website_Screenshots.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4775","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_REMS_Full.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4776","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_REMS_Document.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4777","Health Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Health_Professional_Training.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4778","Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Patient_Care_Program_Instructions_Brochure.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4779","Buy and Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Buy_and_Bill_Pharmacy_Service_Provider_Registration_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4780","Multiple Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Multiple_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4781","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Patient_Registration_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4782","Post-Injection Delirium/Sedation Syndrome Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22-Post_Injection_Delirium_Sedation_Syndrome_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4783","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Pharmacy_Registration_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4784","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Prescriber_Registration_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4785","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Single_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4786","Reconstitution and Administration Training Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Reconstitution_and_Administration_Training_Video.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4787","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_REMS_Website_Screenshots.pdf" "63","Tysabri","1220","04/27/2020","4788","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_REMS_Full.pdf" "63","Tysabri","1220","04/27/2020","4789","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_REMS_Full.pdf" "63","Tysabri","1220","04/27/2020","4790","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_TOUCH_Prescribing_Program_Overview .pdf" "63","Tysabri","1220","04/27/2020","4791","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf" "63","Tysabri","1220","04/27/2020","4792","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Prescriber_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1220","04/27/2020","4793","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Prescriber_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1220","04/27/2020","4794","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Pre-Infusion_Patient_Checklist .pdf" "63","Tysabri","1220","04/27/2020","4795","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Helpful_Information_for_Evaluation_of_New_Neurologic_ Symptoms_in_Patients_Receiving_Tysabri.pdf" "63","Tysabri","1220","04/27/2020","4796","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1220","04/27/2020","4797","TOUCH On-Line REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_TOUCH_On-Line_REMS_Website_Screenshots .pdf" "63","Tysabri","1220","04/27/2020","4798","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Patient_Status_Report_and_Reauthorization_ Questionnaire_MS.pdf" "63","Tysabri","1220","04/27/2020","4799","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Patient_Status_Report_and_Reauthorization_ Questionnaire_CD.pdf" "63","Tysabri","1220","04/27/2020","4800","Initial Discontinuation Questionaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Initial_Discontinuation_Questionaire_MS.pdf" "63","Tysabri","1220","04/27/2020","4801","Initial Discontinuation Questionaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Initial_Discontinuation_Questionaire_CD.pdf" "63","Tysabri","1220","04/27/2020","4802","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_6-Month_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1220","04/27/2020","4803","6-Month Discontinuation Questionnaire (CD))","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_6-Month_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1220","04/27/2020","4804","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1220","04/27/2020","4805","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_04_27_Certified_Pharmacy_Enrollment_Form .pdf" "385","Ultomiris","1221","04/30/2020","4806","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_REMS_Full.pdf" "385","Ultomiris","1221","04/30/2020","4807","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020-04_30_REMS_Document.pdf" "385","Ultomiris","1221","04/30/2020","4808","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1221","04/30/2020","4809","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1221","04/30/2020","4810","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Patient_Safety_Card.pdf" "385","Ultomiris","1221","04/30/2020","4811","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Patient_Safety_Brochure.pdf" "385","Ultomiris","1221","04/30/2020","4812","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_REMS_Website_Screenshots.pdf" "383","Tegsedi","1222","05/11/2020","4813","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Full.pdf" "383","Tegsedi","1222","05/11/2020","4814","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Document.pdf" "383","Tegsedi","1222","05/11/2020","4815","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1222","05/11/2020","4816","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1222","05/11/2020","4817","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Enrollment_Form.pdf" "383","Tegsedi","1222","05/11/2020","4818","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Program_Overview.pdf" "383","Tegsedi","1222","05/11/2020","4819","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Training.pdf" "383","Tegsedi","1222","05/11/2020","4820","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1222","05/11/2020","4821","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Guide.pdf" "383","Tegsedi","1222","05/11/2020","4822","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Wallet_Card.pdf" "383","Tegsedi","1222","05/11/2020","4823","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Status_Form.pdf" "383","Tegsedi","1222","05/11/2020","4824","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Website_Screenshots.pdf" "41","Pomalyst","1223","05/14/2020","4825","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_REMS_Full.pdf" "41","Pomalyst","1223","05/14/2020","4826","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_REMS_Document.pdf" "41","Pomalyst","1223","05/14/2020","4827","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","1223","05/14/2020","4828","Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_an_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1223","05/14/2020","4829","Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_an_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1223","05/14/2020","4830","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_a_Female_ Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1223","05/14/2020","4831","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_a_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1223","05/14/2020","4832","Patient-Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_a_Male_Child.pdf" "41","Pomalyst","1223","05/14/2020","4833","Patient-Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient-Physician_Agreement_Form_for_an_Adult_Male.pdf" "41","Pomalyst","1223","05/14/2020","4834","Prescriber Guide to Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ Prescriber_Guide_to_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1223","05/14/2020","4835","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ Welcome_Letter.pdf" "41","Pomalyst","1223","05/14/2020","4836","Pharmacy Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Pharmacy_Guide_to_the_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1223","05/14/2020","4837","Pomalyst REMS Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ Pomalyst_REMS_Program_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","1223","05/14/2020","4838","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","1223","05/14/2020","4839","Patient Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Patient_Guide_to_the_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1223","05/14/2020","4841","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ _Emergency_Contraception_Brochure.pdf" "41","Pomalyst","1223","05/14/2020","4842","Patient Resource Packet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ Patient_Resource_Packet.pdf" "41","Pomalyst","1223","05/14/2020","4843","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_ Education_and_Counseling_Checklist_for_Pharmacies.pdf" "41","Pomalyst","1223","05/14/2020","4844","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Celgene_Risk_Management_Website_Screenshots.pdf" "41","Pomalyst","1223","05/14/2020","4845","Celgene REMS Programs Pharmacy Training: the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_Celgene_REMS_Programs_Pharmacy_Training.pdf" "41","Pomalyst","1223","05/14/2020","4846","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2020_05_14_REMS_Program_Website_Screenshots.pdf" "343","Natpara","791","01/23/2015","4847","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Full.pdf" "343","Natpara","1224","06/05/2020","4848","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Document.pdf" "343","Natpara","1224","06/05/2020","4849","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_5_Prescriber_Enrollment_Form.pdf" "343","Natpara","1224","06/05/2020","4850","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Prescriber_Training_Module.pdf" "343","Natpara","1224","06/05/2020","4851","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Program_An_Introduction.pdf" "343","Natpara","1224","06/05/2020","4852","Training Module for Pharmacy Representatives","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Training_Module_For_Pharmacy_Representatives.pdf" "343","Natpara","1224","06/05/2020","4853","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Pharmacy_Enrollment_Form.pdf" "343","Natpara","1224","06/05/2020","4854","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020-06_05_Patient_Prescriber_Acknowledgement_Form.pdf" "343","Natpara","1224","06/05/2020","4855","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Patient_Brochure.pdf" "343","Natpara","1224","06/05/2020","4856","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Website_Screenshots.pdf" "343","Natpara","1224","06/05/2020","4857","Frequently Asked Questions (FAQ)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Frequently_Asked_Questions_(FAQ).pdf" "376","Sublocade","1225","06/15/2020","4858","Sublocade REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_REMS_Full.pdf" "376","Sublocade","1225","06/15/2020","4859","Sublocade REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_REMS_Document.pdf" "376","Sublocade","1225","06/15/2020","4860","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1225","06/15/2020","4861","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1225","06/15/2020","4862","Fact Sheet: How to Obtain Sublocade","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_Fact_Sheet_How_to_Obtain_Sublocade.pdf" "376","Sublocade","1225","06/15/2020","4863","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_06_15_REMS_Program_Website_Screenshots.pdf" "400","Fintepla","1227","06/25/2020","4879","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Letter_for_Healthcare_Providers.pdf" "400","Fintepla","1227","06/25/2020","4881","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_REMS_Program_Website_Screenshots.pdf" "400","Fintepla","1227","06/25/2020","4882","Cardiovascular Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Cardiovascular_Adverse_Event_Reporting_Form.pdf" "400","Fintepla","1227","06/25/2020","4883","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Patient_Status_Form.pdf" "400","Fintepla","1227","06/25/2020","4884","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Patient_Guide.pdf" "400","Fintepla","1227","06/25/2020","4885","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Pharmacy_Guide.pdf" "400","Fintepla","1227","06/25/2020","4886","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Prescriber_Knowledge_Assessment.pdf" "400","Fintepla","1227","06/25/2020","4887","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Program_Overview.pdf" "400","Fintepla","1227","06/25/2020","4888","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Inpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1227","06/25/2020","4889","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Prescriber_Training.pdf" "400","Fintepla","1227","06/25/2020","4890","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Outpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1227","06/25/2020","4891","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Patient_Enrollment_Form.pdf" "400","Fintepla","1227","06/25/2020","4892","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_Prescriber_Enrollment_Form.pdf" "400","Fintepla","1227","06/25/2020","4893","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_REMS_Document.pdf" "400","Fintepla","1227","06/25/2020","4894","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2020_06_25_REMS_Full.pdf" "314","Myalept","1228","07/13/2020","4895","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_REMS_Full.pdf" "314","Myalept","1228","07/13/2020","4896","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_REMS_Document.pdf" "314","Myalept","1228","07/13/2020","4897","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_Prescriber_Training_Module.pdf" "314","Myalept","1228","07/13/2020","4898","Prescriber Enrollment form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_Prescriber_Enrollment_Form.pdf" "314","Myalept","1228","07/13/2020","4899","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_REMS_Program_An_Introduction.pdf" "314","Myalept","1228","07/13/2020","4900","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_REMS_Website_Screenshots.pdf" "314","Myalept","1228","07/13/2020","4901","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07-13_Prescription_Authorization_Form.pdf" "314","Myalept","1228","07/13/2020","4902","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_07_13_Letter_to_Healthcare_Providers.pdf" "63","Tysabri","1229","07/07/2020","4903","Certified Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Certified_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1229","07/07/2020","4904","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1229","07/07/2020","4905","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_6_Month_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1229","07/07/2020","4906","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_6_Month_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1229","07/07/2020","4907","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Initial_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1229","07/07/2020","4908","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Initial_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1229","07/07/2020","4909","Patient Status Report and Reauthorization Questionnaire CD","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Patient_Status_Report_and_Reauthorization_Questionnaire_CD.pdf" "63","Tysabri","1229","07/07/2020","4910","Patient Status Report and Reauthorization Questionnaire MS","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Patient_Status_Report_and_Reauthorization_Questionnaire_MS.pdf" "63","Tysabri","1229","07/07/2020","4911","REMS Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1229","07/07/2020","4912","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Helpful_Information_for_Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_MS.pdf" "63","Tysabri","1229","07/07/2020","4913","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Understanding_PML_for_Gastroenterologists_CD.pdf" "63","Tysabri","1229","07/07/2020","4914","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Pre_Infusion_Patient_Checklist.pdf" "63","Tysabri","1229","07/07/2020","4915","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Prescriber_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1229","07/07/2020","4916","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_Prescriber_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1229","07/07/2020","4917","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_TOUCH_Prescribing_Program_Overview.pdf" "63","Tysabri","1229","07/07/2020","4918","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf" "63","Tysabri","1229","07/07/2020","4919","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_REMS_Document.pdf" "63","Tysabri","1229","07/07/2020","4920","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_07_07_REMS_Full.pdf" "21","Gattex","1230","07/14/2020","4921","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Full.pdf" "21","Gattex","1230","07/14/2020","4922","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Document.pdf" "21","Gattex","1230","07/14/2020","4923","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","1230","07/14/2020","4924","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","1230","07/14/2020","4925","Post Training Knowledge Assessment Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Post_Training_Knowledge_Assessment_Questions.pdf" "21","Gattex","1230","07/14/2020","4926","Patient and Cargiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Patient_and_Caregiver_Counseling_Guide.pdf" "21","Gattex","1230","07/14/2020","4927","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Website_Screenshots.pdf" "398","Palforzia","1231","07/17/2020","4928","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_REMS_Full.pdf" "398","Palforzia","1231","07/17/2020","4929","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_REMS_Document.pdf" "398","Palforzia","1231","07/17/2020","4930","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020-07_17_Prescriber_Enrollment_Form.pdf" "398","Palforzia","1231","07/17/2020","4931","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020-07_17_Patient_Enrollment_Form.pdf" "398","Palforzia","1231","07/17/2020","4932","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_Healthcare_Setting_Enrollment_Form.pdf" "398","Palforzia","1231","07/17/2020","4933","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_Pharmacy_Enrollment_Form.pdf" "398","Palforzia","1231","07/17/2020","4934","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_Program_Overview_for_Pharmacies.pdf" "398","Palforzia","1231","07/17/2020","4935","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_Education_Program_for_Healthcare_Settings.pdf" "398","Palforzia","1231","07/17/2020","4936","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_REMS_Website_Screenshots.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4954","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav and Xyrem_2020_07_21_REMS_Full.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4955","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_REMS_Document.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4956","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4957","Paitent Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4958","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4959","XYREM Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and Xyrem_2020_07_21_Xyrem_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4960","XYREM Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Xyrem_ Brochure_for_Pediatric_Patients_and_ their_Caregivers.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4961","XYWAV Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and Xyrem_2020_07_21_Xywav_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4962","XYWAV Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Xywav_ Brochure_for_Pediatric_Patients_and_ their_Caregivers.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4963","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4964","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4965","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4966","XYREM Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Xyrem_Prescription_Form.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4967","XWAV Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Xywav_Prescription_Form.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4968","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4969","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_REMS_Website_Screenshots.pdf" "345","Xywav and Xyrem","1232","07/21/2020","4970","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2020_07_21_Risk_Management_Report.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4971","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_REMS_Full.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4972","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_REMS_Document.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4973","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4974","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4975","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Program_Training.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4976","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4977","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1234","07/24/2020","4978","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_07_24_Website_Screenshots.pdf" "74","Zyprexa Relprevv","1218","04/22/2020","4979","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2020_04_22_Healthcare_Facility_Registration_Form.pdf" "386","Spravato","1235","07/31/2020","4980","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_REMS_Program_Website_Screenshots.pdf" "386","Spravato","1235","07/31/2020","4981","Patient Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_Patient_Monitoring_Form.pdf" "386","Spravato","1235","07/31/2020","4982","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_REMS_Program_Overview.pdf" "386","Spravato","1235","07/31/2020","4983","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_Pharmacy_Enrollment_Form.pdf" "386","Spravato","1235","07/31/2020","4984","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_Patient_Enrollment_Form.pdf" "386","Spravato","1235","07/31/2020","4985","Inpatient Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_Inpatient_Healthcare_Setting_Enrollment_Form.pdf" "386","Spravato","1235","07/31/2020","4986","Outpatient Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_Outpatient_Healthcare_Setting_Enrollment_Form.pdf" "386","Spravato","1235","07/31/2020","4987","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_REMS_Document.pdf" "386","Spravato","1235","07/31/2020","4988","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2020_07_31_REMS_Full.pdf" "389","Turalio","1236","08/04/2020","4989","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_REMS_Program_Website_Screenshots.pdf" "389","Turalio","1236","08/04/2020","4990","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1236","08/04/2020","4991","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Letter_for_Professional_Societies.pdf" "389","Turalio","1236","08/04/2020","4992","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1236","08/04/2020","4993","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Patient_Status_Form.pdf" "389","Turalio","1236","08/04/2020","4994","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Patient_Guide.pdf" "389","Turalio","1236","08/04/2020","4995","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1236","08/04/2020","4996","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Prescriber_Training.pdf" "389","Turalio","1236","08/04/2020","4997","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Program_Overview.pdf" "389","Turalio","1236","08/04/2020","4998","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Patient_Enrollment_Form.pdf" "389","Turalio","1236","08/04/2020","4999","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Pharmacy_Enrollment_Form.pdf" "389","Turalio","1236","08/04/2020","5000","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_Prescriber_Enrollment_Form.pdf" "389","Turalio","1236","08/04/2020","5001","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_REMS_Document.pdf" "389","Turalio","1236","08/04/2020","5002","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_REMS_Full.pdf" "403","Blenrep","1237","08/05/2020","5003","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep-2020_08_05_REMS_Full.pdf" "403","Blenrep","1237","08/05/2020","5004","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_REMS_Document.pdf" "403","Blenrep","1237","08/05/2020","5005","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Prescriber_Enrollment_Form.pdf" "403","Blenrep","1237","08/05/2020","5006","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Patient_Enrollment_Form.pdf" "403","Blenrep","1237","08/05/2020","5007","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Healthcare_Setting_Enrollment_Form.pdf" "403","Blenrep","1237","08/05/2020","5008","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Patient_Status_Form.pdf" "403","Blenrep","1237","08/05/2020","5009","REMS Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_REMS_Checklist.pdf" "403","Blenrep","1237","08/05/2020","5010","Eye Care Professional Consult Request Form Training and Educational Materials","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Eye_Care_Professional_Consult_Request_Form.pdf" "403","Blenrep","1237","08/05/2020","5011","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Program_Overview.pdf" "403","Blenrep","1237","08/05/2020","5012","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Prescriber_Knowledge_Assessment.pdf" "403","Blenrep","1237","08/05/2020","5013","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Education_Program_for_Prescribers.pdf" "403","Blenrep","1237","08/05/2020","5014","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Patient_Guide.pdf" "403","Blenrep","1237","08/05/2020","5015","Education Program for Health Care Settings Communication Materials","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_Education_Program_for_Health_Care_Settings.pdf" "403","Blenrep","1237","08/05/2020","5016","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_ Healthcare_Provider_REMS_Letter.pdf" "403","Blenrep","1237","08/05/2020","5017","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_REMS_Fact_Sheet.pdf" "403","Blenrep","1237","08/05/2020","5018","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_REMS_Letter_for_Professional_Societies.pdf" "403","Blenrep","1237","08/05/2020","5019","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_08_05_ REMS_Website_Screenshots.pdf" "403","Blenrep","1238","09/10/2020","5020","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Program_Website_Screenshots.pdf" "403","Blenrep","1238","09/10/2020","5021","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Fact_Sheet.pdf" "403","Blenrep","1238","09/10/2020","5022","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Letter_for_Professional_Societies.pdf" "403","Blenrep","1238","09/10/2020","5023","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Healthcare_Provider_REMS_Letter.pdf" "403","Blenrep","1238","09/10/2020","5024","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Education_Program_for_Healthcare_Settings.pdf" "403","Blenrep","1238","09/10/2020","5025","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Guide.pdf" "403","Blenrep","1238","09/10/2020","5026","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Prescriber_Knowledge_Assessment.pdf" "403","Blenrep","1238","09/10/2020","5027","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Education_Program_For_Prescribers.pdf" "403","Blenrep","1238","09/10/2020","5028","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Program_Overview.pdf" "403","Blenrep","1238","09/10/2020","5029","Eye Care Professional Consult Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Eye_Care_Professional_Consult_Request_Form.pdf" "403","Blenrep","1238","09/10/2020","5030","REMS Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Checklist.pdf" "403","Blenrep","1238","09/10/2020","5031","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Status_Form.pdf" "403","Blenrep","1238","09/10/2020","5032","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Healthcare_Setting_Enrollment_Form.pdf" "403","Blenrep","1238","09/10/2020","5033","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Enrollment_Form.pdf" "403","Blenrep","1238","09/10/2020","5034","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Prescriber_Enrollment_Form.pdf" "403","Blenrep","1238","09/10/2020","5035","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Document.pdf" "403","Blenrep","1238","09/10/2020","5036","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Full.pdf" "46","Revlimid","1239","09/24/2020","5037","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_REMS_Full.pdf" "46","Revlimid","1239","09/24/2020","5038","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_REMS_Document.pdf" "46","Revlimid","1239","09/24/2020","5039","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Prescriber_Enrollment_Form.pdf" "46","Revlimid","1239","09/24/2020","5040","Patient Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Female_Child_Who_Can_Get_Pregnant.pdf" "46","Revlimid","1239","09/24/2020","5041","Patient Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Adult_Female_Who_Can_Get_Pregnant.pdf" "46","Revlimid","1239","09/24/2020","5046","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Welcome_Letter.pdf" "46","Revlimid","1239","09/24/2020","5047","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Prescriber_Guide.pdf" "46","Revlimid","1239","09/24/2020","5048","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Education_and_Prescribing_Safety_Kit.pdf" "46","Revlimid","1239","09/24/2020","5049","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Pharmacy_Guide.pdf" "46","Revlimid","1239","09/24/2020","5050","Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Pharmacy_Training.pdf" "46","Revlimid","1239","09/24/2020","5051","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Pharmacy_Certification_Quiz.pdf" "46","Revlimid","1239","09/24/2020","5052","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Guide.pdf" "46","Revlimid","1239","09/24/2020","5053","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Resource_Pack_Envelope.pdf" "46","Revlimid","1239","09/24/2020","5054","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Emergency_Contraception_Brochure.pdf" "46","Revlimid","1239","09/24/2020","5055","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "46","Revlimid","1239","09/24/2020","5056","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_REMS_Website_Screenshots.pdf" "364","Vigabatrin","1240","10/02/2020","5057","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_REMS_Full.pdf" "364","Vigabatrin","1240","10/02/2020","5058","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_REMS_Document.pdf" "364","Vigabatrin","1240","10/02/2020","5059","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_Prescriber_Enrollment_and_Agreement_Form.pdf" "364","Vigabatrin","1240","10/02/2020","5060","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","1240","10/02/2020","5061","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_Patient_Parent_Legal_Guardian-Physician_Agreement_Form.pdf" "364","Vigabatrin","1240","10/02/2020","5062","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_Patient_Guide.pdf" "364","Vigabatrin","1240","10/02/2020","5063","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2020_10_02_REMS_Website_Screenshots.pdf" "381","Palynziq","1241","10/06/2020","5064","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Program_Overview.pdf" "381","Palynziq","1241","10/06/2020","5065","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_REMS_Program_Website_Screenshots.pdf" "381","Palynziq","1241","10/06/2020","5066","Safety Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Safety_Video.pdf" "381","Palynziq","1241","10/06/2020","5067","Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Wallet_Card.pdf" "381","Palynziq","1241","10/06/2020","5068","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Patient_Guide.pdf" "381","Palynziq","1241","10/06/2020","5069","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Prescriber_Knowledge_Assessment.pdf" "381","Palynziq","1241","10/06/2020","5070","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Prescriber_Guide.pdf" "381","Palynziq","1241","10/06/2020","5071","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Patient_Enrollment_Form.pdf" "381","Palynziq","1241","10/06/2020","5072","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Pharmacy_Enrollment_Form.pdf" "381","Palynziq","1241","10/06/2020","5073","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_Prescriber_Enrollment_Form.pdf" "381","Palynziq","1241","10/06/2020","5074","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_REMS_Document.pdf" "381","Palynziq","1241","10/06/2020","5075","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2020_10_06_REMS_Full.pdf" "63","Tysabri","1242","10/05/2020","5076","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Full.pdf" "63","Tysabri","1242","10/05/2020","5077","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Document.pdf" "63","Tysabri","1242","10/05/2020","5078","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf" "63","Tysabri","1242","10/05/2020","5079","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_TOUCH_Prescribing_Program_Overview .pdf" "63","Tysabri","1242","10/05/2020","5080","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1242","10/05/2020","5081","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Prescriber_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1242","10/05/2020","5082","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Prescriber_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1242","10/05/2020","5083","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Pre-Infusion_Patient_Checklist.pdf" "63","Tysabri","1242","10/05/2020","5084","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Helpful_Information_for_Evaluation_of_New_ Neurologic_Symptoms_in_Patients_Receiving_Tysabri.pdf" "63","Tysabri","1242","10/05/2020","5085","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Website_Screenshots.pdf" "63","Tysabri","1242","10/05/2020","5086","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Change_Prescriber_Authorization_Form.pdf" "63","Tysabri","1242","10/05/2020","5087","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Patient_Status_Report_and_Reauthorization_Questionnaire_MS.pdf" "63","Tysabri","1242","10/05/2020","5088","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Patient_Status_Report_and_Reauthorization_Questionnaire_CD.pdf" "63","Tysabri","1242","10/05/2020","5089","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Initial_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1242","10/05/2020","5090","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Initial_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1242","10/05/2020","5091","6-Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_6-Month_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1242","10/05/2020","5092","6-Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_6-Month_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1242","10/05/2020","5093","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Certified_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","142","10/07/2011","5094","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Infusion_Site_Enrollment_Form.pdf" "46","Revlimid","1239","09/24/2020","5095","Patient Physician Agreement Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Adult_Male.pdf" "46","Revlimid","1239","09/24/2020","5096","Patient Physician Agreement Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Male_Child.pdf" "46","Revlimid","1239","09/24/2020","5097","Patient Physician Agreement Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "46","Revlimid","1239","09/24/2020","5098","Patient Physician Agreement Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2020_09_24_Patient_Physician_Agreement_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "63","Tysabri","1242","10/05/2020","5099","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Infusion_Site_Enrollment_Form.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5100","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_REMS_Full.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5101","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_REMS_Document.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5102","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5103","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5104","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5105","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5106","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1243","10/01/2020","5107","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_10_01_REMS_Website_Screenshots.pdf" "387","Zulresso","1244","10/14/2020","5108","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_REMS_Full.pdf" "387","Zulresso","1244","10/14/2020","5109","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_REMS_Document.pdf" "387","Zulresso","1244","10/14/2020","5110","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Program_Overview_for_Pharmacies.pdf" "387","Zulresso","1244","10/14/2020","5111","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Post_Infusion_Form.pdf" "387","Zulresso","1244","10/14/2020","5112","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1244","10/14/2020","5113","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Patient_Information_Guide.pdf" "387","Zulresso","1244","10/14/2020","5114","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Patient_Enrollment_Form.pdf" "387","Zulresso","1244","10/14/2020","5115","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1244","10/14/2020","5116","Healthcare Setting Knowledge Assessment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1244","10/14/2020","5117","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1244","10/14/2020","5118","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Excessive_Sedation_and_Loss_of_Consciousness_Form.pdf" "387","Zulresso","1244","10/14/2020","5119","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1244","10/14/2020","5120","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2020_10_14_REMS_Website_Screenshots.pdf" "314","Myalept","1245","10/15/2020","5121","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_REMS_Full.pdf" "314","Myalept","1245","10/15/2020","5122","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_REMS_Document.pdf" "314","Myalept","1245","10/15/2020","5123","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_Prescriber_Training_Module.pdf" "314","Myalept","1245","10/15/2020","5124","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_Prescriber_Enrollment_Form.pdf" "314","Myalept","1245","10/15/2020","5125","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_REMS_Program_An_Introduction.pdf" "314","Myalept","1245","10/15/2020","5126","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_REMS_Website_Screenshots.pdf" "314","Myalept","1245","10/15/2020","5127","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_Prescription_Authorization_Form.pdf" "314","Myalept","1245","10/15/2020","5128","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2020_10_15_Letter_to_Healthcare_Providers.pdf" "25","Juxtapid","1247","10/21/2020","5129","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_REMS_Full.pdf" "25","Juxtapid","1247","10/21/2020","5130","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_REMS_Document.pdf" "25","Juxtapid","1247","10/21/2020","5131","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Prescription_Authorization_Form.pdf" "25","Juxtapid","1247","10/21/2020","5132","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1247","10/21/2020","5133","Prescriber Training and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1247","10/21/2020","5134","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Fact_Sheet.pdf" "25","Juxtapid","1247","10/21/2020","5135","Patient Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1247","10/21/2020","5136","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Patient_Guide.pdf" "25","Juxtapid","1247","10/21/2020","5137","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Letter_for_Healthcare_Providers.pdf" "25","Juxtapid","1247","10/21/2020","5138","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_REMS_Webiste_Screenshots.pdf" "25","Juxtapid","1247","10/21/2020","5139","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1247","10/21/2020","5140","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1247","10/21/2020","5141","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2020_10_21_Letter_for_Pharmacists.pdf" "404","Pomalidomide","1248","10/30/2020","5142","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Program_Website_Screenshots.pdf" "404","Pomalidomide","1248","10/30/2020","5143","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "404","Pomalidomide","1248","10/30/2020","5144","Patient Resources Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Resource_Pack_Envelope.pdf" "404","Pomalidomide","1248","10/30/2020","5145","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Emergency_Contraception_Brochure.pdf" "404","Pomalidomide","1248","10/30/2020","5146","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Guide.pdf" "404","Pomalidomide","1248","10/30/2020","5147","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Certification_Quiz.pdf" "404","Pomalidomide","1248","10/30/2020","5148","Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Training.pdf" "404","Pomalidomide","1248","10/30/2020","5149","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Guide.pdf" "404","Pomalidomide","1248","10/30/2020","5150","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Education_and_Prescribing_Safety_Kit.pdf" "404","Pomalidomide","1248","10/30/2020","5151","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Prescriber_Guide.pdf" "404","Pomalidomide","1248","10/30/2020","5152","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Welcome_Letter.pdf" "404","Pomalidomide","1248","10/30/2020","5153","Patient Physician Agreement Form Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Male_Child.pdf" "404","Pomalidomide","1248","10/30/2020","5154","Patient Physician Agreement Form Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Male.pdf" "404","Pomalidomide","1248","10/30/2020","5155","Patient Physician Agreement Form Female Child Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Female_Child_Who_Cannot_Get_Pregnant.pdf" "404","Pomalidomide","1248","10/30/2020","5156","Patient Physician Agreement Form Adult Females Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Females_Who_Cannot_Get_Pregnant.pdf" "404","Pomalidomide","1248","10/30/2020","5157","Patient Physician Agreement Form Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Female_Child_Who_Can_Get_Pregnant.pdf" "404","Pomalidomide","1248","10/30/2020","5158","Patient Physician Agreement Form Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Female_Who_Can_Get_Pregnant.pdf" "404","Pomalidomide","1248","10/30/2020","5159","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Enrollment_Form.pdf" "404","Pomalidomide","1248","10/30/2020","5160","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Prescriber_Enrollment_Form.pdf" "404","Pomalidomide","1248","10/30/2020","5161","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Document.pdf" "404","Pomalidomide","1248","10/30/2020","5162","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Full.pdf" "403","Blenrep","1249","11/20/2020","5163","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_REMS_Full.pdf" "403","Blenrep","1249","11/20/2020","5164","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_REMS_Document.pdf" "403","Blenrep","1249","11/20/2020","5165","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Education_Program_for_Healthcare_Settings.pdf" "403","Blenrep","1249","11/20/2020","5166","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Education_Program_for_Prescribers.pdf" "403","Blenrep","1249","11/20/2020","5167","Eye Care Professional Consult Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Eye_Care_Professional_Consult_Request_Form .pdf" "403","Blenrep","1249","11/20/2020","5168","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Fact_Sheet.pdf" "403","Blenrep","1249","11/20/2020","5169","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Healthcare_Provider_REMS_Letter.pdf" "403","Blenrep","1249","11/20/2020","5170","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Healthcare_Setting_Enrollment_Form.pdf" "403","Blenrep","1249","11/20/2020","5171","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Letter_for_Professional_Societies.pdf" "403","Blenrep","1249","11/20/2020","5172","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Patinet_Enrollment_Form.pdf" "403","Blenrep","1249","11/20/2020","5173","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Patient_Guide.pdf" "403","Blenrep","1249","11/20/2020","5174","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Patient_Status_Form.pdf" "403","Blenrep","1249","11/20/2020","5175","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Prescriber_Enrollment_Form.pdf" "403","Blenrep","1249","11/20/2020","5176","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Prescriber_Knowledge_Assessment.pdf" "403","Blenrep","1249","11/20/2020","5177","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_Program_Overview.pdf" "403","Blenrep","1249","11/20/2020","5178","REMS Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_REMS_Checklist.pdf" "403","Blenrep","1249","11/20/2020","5179","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_11_20_REMS_Program_Website_Screenshots.pdf" "380","Jynarque","1250","11/25/2020","5180","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_REMS_Program_Website_Screenshots.pdf" "380","Jynarque","1250","11/25/2020","5181","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Letter_for_Healthcare_Providers.pdf" "380","Jynarque","1250","11/25/2020","5182","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1250","11/25/2020","5183","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Patient_Guide.pdf" "380","Jynarque","1250","11/25/2020","5184","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Patient_Status_Form.pdf" "380","Jynarque","1250","11/25/2020","5185","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1250","11/25/2020","5186","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Prescriber_Training.pdf" "380","Jynarque","1250","11/25/2020","5187","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Program_Overview.pdf" "380","Jynarque","1250","11/25/2020","5188","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1250","11/25/2020","5189","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1250","11/25/2020","5190","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Patient_Enrollment_Form.pdf" "380","Jynarque","1250","11/25/2020","5191","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1250","11/25/2020","5192","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_REMS_Document.pdf" "380","Jynarque","1250","11/25/2020","5193","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2020_11_25_REMS_Full.pdf" "149","Adempas","1251","11/30/2020","5194","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_REMS_Full.pdf" "149","Adempas","1251","11/30/2020","5195","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_REMS_Document.pdf" "149","Adempas","1251","11/30/2020","5196","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Prescriber_Enrollment_and_Agreement_Form .pdf" "149","Adempas","1251","11/30/2020","5197","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Patient_Enrollment_and_Consent_Form.pdf" "149","Adempas","1251","11/30/2020","5198","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Inpatient_Pharmacy_Enrollment_Form.pdf" "149","Adempas","1251","11/30/2020","5199","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Prescriber_and_Pharmacy_Guide.pdf" "149","Adempas","1251","11/30/2020","5200","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Guide_for_Female_Patients.pdf" "149","Adempas","1251","11/30/2020","5201","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_Change_in_Reproductive_Potential_Status_and_Pre-pubertal_Annual_Verification_Form .pdf" "149","Adempas","1251","11/30/2020","5202","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2020_11_30_REMS_Website_Screenshots.pdf" "376","Sublocade","1252","12/02/2020","5203","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_REMS_Program_Website_Screenshots.pdf" "376","Sublocade","1252","12/02/2020","5204","Fact Sheet: How to Obtain Sublocade","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_Fact_Sheet_How_to_Obtain_Sublocade.pdf" "376","Sublocade","1252","12/02/2020","5205","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1252","12/02/2020","5206","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1252","12/02/2020","5207","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_REMS_Document.pdf" "376","Sublocade","1252","12/02/2020","5208","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2020_12_02_REMS_Full.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5209","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Full.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5210","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Document.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5211","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5212","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5213","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers .pdf" "352","Suboxone/Subutex","1253","12/02/2020","5214","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5215","Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists (","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "352","Suboxone/Subutex","1253","12/02/2020","5216","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5217","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5218","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5219","Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5220","Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5221","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5222","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_Prescriber_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5223","Pharmacist Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_Pharmacist_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","5224","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2020_10_30_REMS_Website_Screenshots.pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5246","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_REMS_Full.pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5247","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_REMS_Document.pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5248","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Prescriber_Enrollment_and_Agreement_Form .pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5249","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Patient_Enrollment_and_Consent_Form .pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5250","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Outpatient_Pharmacy_Enrollment__Form .pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5251","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Inpatient_Pharmacy_Enrollment__Form .pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5252","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Guide_for_Female_Patients.pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5253","Change in Reproductive Status and Pre-Pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Change_in_Reproductive_Status_and PrePubertal_Annual_Verification _Form .pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5254","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_Prescriber_and_Pharmacy_Guide.pdf" "396","Ambrisentan Shared System","1256","12/22/2020","5255","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2020_12_22_REMS_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5256","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Program_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5257","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5258","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5259","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5260","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5261","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5262","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Discontinuation_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5263","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Status_and_Opioid_Tolerance_form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5264","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5265","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Pharmacy_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5266","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Counseling_Guide.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5267","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5268","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5269","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5270","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5271","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5272","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5273","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","5274","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Full.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5275","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_REMS_Full.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5276","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_REMS_Document.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5277","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5278","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_Knowledge_Assessment_Form.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5279","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5280","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5281","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_Program_Training.pdf" "375","Yescarta and Tecartus","1258","12/09/2020","5282","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2020_12_09_REMS_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5283","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Program_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5284","Patient Monthly Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Monthly_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5285","Patient Information/Informed Consent for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Information_Informed_Consent_About_Birth_Defects_for_female_patients_who_can_get_pregnant.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5286","Isotretinoin Educational Kit for Female Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Isotretinoin_Educational_Kit_for_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5287","Patient Information/Informed Consent for All Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Information_Informed_Consent_for_all_patients.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5288","Isotretinoin Educational Kit for Male Patients and Female Patients of Non-Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Isotretinoin_Educational_Kit_for_Male_Patients_and_Female_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5289","Patient Introductory Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Introductory_Brochure.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5290","Guide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Guide_to_Isotretinoin_for_Male_Patients_and_Female_Patients_who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5291","Guide to Isotretinoin for Female Patients who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Guide_to_Isotretinoin_For_Female_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5292","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5293","Pharmacist Guide for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Pharmacist_Guide_for_the_iPLEDGE_Program.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5294","Instructions for Managing Office Staff Designees","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Instructions_for_Managing_Office_Staff_Designees.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5295","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5296","Office Staff Designee Registration/Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Office_Staff_Designee_Registration_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5297","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Recognizing_Psychiatric_Disorders_in_Adolescents_And_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5298","Steps to Request an Exemption for Female Patients with Serious Medical Reasons","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Steps_to_Request_an_Exemption_for_Female_Patients_with_Serious_Medical_Reasons.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5299","DVDs for Prescriber Use in Patient Counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_DVDs_for_prescriber_use_in_patient_counseling_Be_Prepared_Be_Protected_and_Be_Aware_The_Risk_of_Pregnancy_While_on_Isotretinoin.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5300","Prescriber Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Prescriber_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5301","The Guide to Best Practices for the iPLEDGE Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_The_Guide_to_Best_Practices_For_The_iPLEDGE_Program.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5302","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1255","12/09/2020","5303","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Full.pdf" "37","Mycophenolate","1259","01/15/2021","5304","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_REMS_Full.pdf" "37","Mycophenolate","1259","01/15/2021","5305","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_REMS_Document.pdf" "37","Mycophenolate","1259","01/15/2021","5306","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","1259","01/15/2021","5307","Patient Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Patient_Information_Brochure.pdf" "37","Mycophenolate","1259","01/15/2021","5308","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Website_Banner.pdf" "37","Mycophenolate","1259","01/15/2021","5309","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_REMS_Website_Screenshots.pdf" "37","Mycophenolate","1259","01/15/2021","5310","Healthcare Provider Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Healthcare_Provider_Training.pdf" "37","Mycophenolate","1259","01/15/2021","5311","Dear Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Dear_Healthcare_Provider_Letter_1.pdf" "37","Mycophenolate","1259","01/15/2021","5312","Dear Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Dear_Healthcare_Provider_Letter_2.pdf" "37","Mycophenolate","1259","01/15/2021","5313","Dear Healthcare Provider Letter for Centers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf" "37","Mycophenolate","1259","01/15/2021","5314","Dear Healthcare Provider Letter for Centers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf" "37","Mycophenolate","1259","01/15/2021","5315","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","1259","01/15/2021","5316","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","1259","01/15/2021","5317","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients Communication Materials","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients_Communication_Materials.pdf" "37","Mycophenolate","1259","01/15/2021","5319","FDA Blueprint for Mycophenolate REMS Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_01_15_FDA_ Blueprint_for_Mycophenolate_REMS_Education.pdf" "362","Siliq","1261","01/22/2021","5320","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_REMS_Program_Website_Screenshots.pdf" "362","Siliq","1261","01/22/2021","5321","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_Patient_Wallet_Card.pdf" "362","Siliq","1261","01/22/2021","5322","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1261","01/22/2021","5323","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_Patient_Enrollment_Form.pdf" "362","Siliq","1261","01/22/2021","5324","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_Prescriber_Enrollment_Form.pdf" "362","Siliq","1261","01/22/2021","5325","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_REMS_Document.pdf" "362","Siliq","1261","01/22/2021","5326","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2021_01_22_REMS_Full.pdf" "362","Siliq","1261","01/22/2021","5327","","" "405","Breyanzi","1263","02/05/2021","5328","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Full.pdf" "405","Breyanzi","1263","02/05/2021","5329","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Document.pdf" "405","Breyanzi","1263","02/05/2021","5330","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Hospital_Enrollment_Form.pdf" "405","Breyanzi","1263","02/05/2021","5331","Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Training_Program.pdf" "405","Breyanzi","1263","02/05/2021","5332","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Knowledge_Assessment.pdf" "405","Breyanzi","1263","02/05/2021","5333","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_Patient_Wallet_Card.pdf" "405","Breyanzi","1263","02/05/2021","5334","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2021_02_05_REMS_Website_Screenshots.pdf" "21","Gattex","1264","02/11/2021","5335","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_REMS_Full.pdf" "21","Gattex","1264","02/11/2021","5336","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_REMS_Document.pdf" "21","Gattex","1264","02/11/2021","5337","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","1264","02/11/2021","5338","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","1264","02/11/2021","5339","Post Training Knowledge Assessment Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_Post_Training_Knowledge_Assessment_Questions.pdf" "21","Gattex","1264","02/11/2021","5340","Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_Patient_and_Caregiver_Counseling_Guide.pdf" "21","Gattex","1264","02/11/2021","5341","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2021_02_11_REMS_Website_Screenshots.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5342","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav and Xyrem_2021_02_11_REMS_Full.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5343","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_REMS_Document.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5344","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11-Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5345","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5346","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11-Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5348","Xywav Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xywav_Brochure_for_Pediatric_Patients_and_their_Caregivers .pdf" "345","Xywav and Xyrem","1265","02/11/2021","5349","Certified Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Certified_Pharmacy_Training.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5350","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5351","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Module__B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5352","Xywav Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xywav_Prescription_Form.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5353","Xyrem Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xyrem_Prescription_Form.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5354","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5355","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5356","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_REMS_Website_Screenshots.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5357","Xyrem Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xyrem_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1265","02/11/2021","5359","Xyrem Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xyrem_Brochure_for_Pediatric_Patients_and_their_Caregivers .pdf" "345","Xywav and Xyrem","1265","02/11/2021","5360","Xywav Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_02_11_Xywav_Patient_Quick_Start_Guide.pdf" "351","Clozapine","1266","02/18/2021","5361","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_REMS_Program_Website_Screenshots.pdf" "351","Clozapine","1266","02/18/2021","5362","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Patient_Enrollment_Form.pdf" "351","Clozapine","1266","02/18/2021","5363","A Guide for Patients and Caregivers: What You Need to Know about Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_A_Guide_for_Patients_and_Caregivers_What_You_Need_to_Know_about_Clozapine_and_Neutropenia.pdf" "351","Clozapine","1266","02/18/2021","5364","Chain Headquarters Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Chain_Headquarters_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1266","02/18/2021","5365","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Outpatient_Pharmacy_Enrollment_form.pdf" "351","Clozapine","1266","02/18/2021","5366","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1266","02/18/2021","5367","Prescriber Designee Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Prescriber_Designee_Enrollment_Form.pdf" "351","Clozapine","1266","02/18/2021","5368","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_ANC_Lab_Reporting_Form.pdf" "351","Clozapine","1266","02/18/2021","5369","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1266","02/18/2021","5370","Knowledge Assessment for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Knowledge_Assessment_for_Healthcare_Providers.pdf" "351","Clozapine","1266","02/18/2021","5371","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1266","02/18/2021","5372","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_REMS_document.pdf" "351","Clozapine","1266","02/18/2021","5373","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_02_18_REMS_Full.pdf" "341","Blincyto","1267","03/11/2021","5374","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_Program_Website.pdf" "341","Blincyto","1267","03/11/2021","5375","Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_Fact_Sheet_for_Providers.pdf" "341","Blincyto","1267","03/11/2021","5376","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_Letter_for_Professional_Societies.pdf" "341","Blincyto","1267","03/11/2021","5377","Letter for Hospital and Home Healthcare Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_Letter_for_Hospital_and_Home_Healthcare_Pharmacists.pdf" "341","Blincyto","1267","03/11/2021","5378","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_Letter_for_Healthcare_Providers.pdf" "341","Blincyto","1267","03/11/2021","5379","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_REMS_Document.pdf" "341","Blincyto","1267","03/11/2021","5380","Rems Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto_2021_03_11_REMS_Full.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5381","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_Program_Training.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5382","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5383","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5384","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5385","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5386","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_REMS_Document.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5387","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_03_05_REMS_Program_Website.pdf" "375","Yescarta and Tecartus","1268","03/05/2021","5388","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_ 2021_03_05_REMS_Full.pdf" "340","Lemtrada","1269","03/12/2021","5389","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Healthcare_Provider_Letter.pdf" "340","Lemtrada","1269","03/12/2021","5390","Patient Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Letter.pdf" "340","Lemtrada","1269","03/12/2021","5391","REMS Program Website www.LemtradaREMS.com","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Program_Website_www.LemtradaREMS.com.pdf" "340","Lemtrada","1269","03/12/2021","5392","Patient Transfer of Care Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Transfer_of_Care_form.pdf" "340","Lemtrada","1269","03/12/2021","5393","REMS Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Infusion_Checklist.pdf" "340","Lemtrada","1269","03/12/2021","5394","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Status_Form.pdf" "340","Lemtrada","1269","03/12/2021","5395","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Authorization_and_Baseline_Lab_Form.pdf" "340","Lemtrada","1269","03/12/2021","5396","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1269","03/12/2021","5397","LEMTRADA Treatment and Infusion Reactions Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_LEMTRADA_Treatment_and_Infusion_Reactions_Patient_Guide.pdf" "340","Lemtrada","1269","03/12/2021","5398","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Prescriber_Knowledge_Assessment.pdf" "340","Lemtrada","1269","03/12/2021","5399","REMS Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Education_Program.pdf" "340","Lemtrada","1269","03/12/2021","5400","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1269","03/12/2021","5401","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1269","03/12/2021","5402","Patient Enrollment and Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient Enrollment_and_Prescription_Ordering_Form.pdf" "340","Lemtrada","1269","03/12/2021","5403","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1269","03/12/2021","5404","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Document.pdf" "340","Lemtrada","1269","03/12/2021","5405","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Full.pdf" "406","Abecma","1270","03/26/2021","5406","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_Adverse_Reaction_Management_Guide.pdf" "406","Abecma","1270","03/26/2021","5407","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_Knowledge_Assessment.pdf" "406","Abecma","1270","03/26/2021","5408","Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_Training_Program.pdf" "406","Abecma","1270","03/26/2021","5409","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_Patient_Wallet_Card.pdf" "406","Abecma","1270","03/26/2021","5410","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_Hospital_Enrollment_Form.pdf" "406","Abecma","1270","03/26/2021","5411","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_REMS_Document.pdf" "406","Abecma","1270","03/26/2021","5412","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_03_26_ REMS_Full.pdf" "45","Qsymia","1271","03/31/2021","5413","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Full.pdf" "45","Qsymia","1271","03/31/2021","5414","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Document.pdf" "45","Qsymia","1271","03/31/2021","5415","Risk of Birth Defects with Qsymia Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Risk_of_Birth_Defects_with_Qsymia_patient_brochure.pdf" "45","Qsymia","1271","03/31/2021","5416","Healthcare Provider Counseling Tool for Females of Reproductive Potential","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Healthcare_Provider_Counseling_Tool_for_Females_of_Reproductive_Potential.pdf" "45","Qsymia","1271","03/31/2021","5417","Online Qsymia REMS Healthcare Provider Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Online_Qsymia_REMS_Healthcare_Provider_Training.pdf" "45","Qsymia","1271","03/31/2021","5418","Online Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Online_Qsymia_REMS_Pharmacy_Training_module.pdf" "45","Qsymia","1271","03/31/2021","5419","Print Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Print_Qsymia_REMS_Pharmacy_Training_module.pdf" "45","Qsymia","1271","03/31/2021","5420","Print Qsymia REMS Healthcare Provider Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Print_Qsymia_REMS_Healthcare_Provider_Training .pdf" "45","Qsymia","1271","03/31/2021","5421","Dear Medical Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Dear_Medical_Society_letter.pdf" "45","Qsymia","1271","03/31/2021","5422","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Dear_Healthcare_Provider_letter.pdf" "45","Qsymia","1271","03/31/2021","5423","Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Corporate_Entity_of_Retail_Chain_Pharmacy.pdf" "45","Qsymia","1271","03/31/2021","5424","Pharmacy Enrollment Form, Independent Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Independent_Pharmacy.pdf" "45","Qsymia","1271","03/31/2021","5425","Pharmacy Enrollment Form, Mail Order Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Mail_Order_Pharmacy.pdf" "45","Qsymia","1271","03/31/2021","5426","Prescriber Dosing and Management Checklis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Prescriber_Dosing_and_Management_Checklist.pdf" "45","Qsymia","1271","03/31/2021","5427","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Website_Screenshots.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5428","REMS Program Website (www.MacitentanREMSProgram.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_REMS_Program_website_(www.MacitentanREMSProgram.com).pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5429","Change in Reproductive Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Change_in_Reproductive_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5430","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Guide_for_Female_Patients.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5431","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Prescriber_and_Pharmacy_Guide.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5432","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Outpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5433","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Inpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5434","Patient Enrollment Form for VA use only","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Patient_Enrollment_Form_for_VA_use_only.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5435","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Patient_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5436","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_Prescriber_Enrollment_and_Agreement_Form.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5437","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_REMS_Document.pdf" "407","Macitentan-Containing Products","1273","04/06/2021","5438","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2021_04_06_REMS_Full.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5439","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_Program_Training.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5440","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5441","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5442","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5443","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5444","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_REMS_Document.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5445","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_REMS_Full.pdf" "375","Yescarta and Tecartus","1274","04/22/2021","5446","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_04_22_REMS_Program_Website.pdf" "37","Mycophenolate","1276","04/21/2021","5447","Patient Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Patient_Information_Brochure.pdf" "37","Mycophenolate","1276","04/21/2021","5448","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_REMS_Full.pdf" "37","Mycophenolate","1276","04/21/2021","5449","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","1276","04/21/2021","5450","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","1276","04/21/2021","5451","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Program_Website.pdf" "37","Mycophenolate","1276","04/21/2021","5452","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Website_Banner.pdf" "37","Mycophenolate","1276","04/21/2021","5453","Dear Healthcare Provider Letter for Centers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf" "37","Mycophenolate","1276","04/21/2021","5454","Dear Healthcare Provider Letter for Centers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf" "37","Mycophenolate","1276","04/21/2021","5455","Dear Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Dear_Healthcare_Provider_Letter_2.pdf" "37","Mycophenolate","1276","04/21/2021","5456","Dear Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Dear_Healthcare_Provider_Letter_1.pdf" "37","Mycophenolate","1276","04/21/2021","5457","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf" "37","Mycophenolate","1276","04/21/2021","5458","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","1276","04/21/2021","5459","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_REMS_Document.pdf" "37","Mycophenolate","1276","04/21/2021","5460","FDA Blueprint for Mycophenolate REMS Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_04_21_FDA_ Blueprint_for_Mycophenolate_REMS_Education.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5461","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Full.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5462","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Document.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5463","Prescriber Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Prescriber_Registration_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5464","Patient Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Patient_Registration_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5465","Pharmacy Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Pharmacy_Registration_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5466","Healthcare Facility Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Healthcare_Facility_Registration_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5467","Buy and Bill Pharmacy Service Provider Registration Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Buy_and_Bill_Pharmacy_Service_Provider_Registration_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5468","Reconstitution and Administration Training Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Reconstitution_and_Administration-Training_Video.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5469","Healthcare Professional Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Healthcare_Professional_Training.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5470","Single Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Single_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5471","Post-Injection Delirium/Sedation Syndrome Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Post_Injection_Delirium_Sedation_Syndrome_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5472","Patient Care Program Instructions Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Patient_Care_Program_Instructions_Brochure.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5473","Multiple Patient Injection Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Multiple_Patient_Injection_Form.pdf" "74","Zyprexa Relprevv","1277","04/28/2021","5474","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Website_Screenshots.pdf" "390","Mifepristone","1279","05/14/2021","5475","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_REMS_Full.pdf" "390","Mifepristone","1279","05/14/2021","5476","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_REMS_Document.pdf" "390","Mifepristone","1279","05/14/2021","5477","Prescriber Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_Prescriber_Agreement_Form_Danco_Laboratories_LLC.pdf" "390","Mifepristone","1279","05/14/2021","5478","Prescriber Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_Prescriber_Agreement_Form_GenBioPro_Inc.pdf" "390","Mifepristone","1279","05/14/2021","5479","Patient Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_Patient_Agreement_Form.pdf" "409","Empaveli","1281","05/14/2021","5480","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Program_Website.pdf" "409","Empaveli","1281","05/14/2021","5481","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Patient_Wallet_Card.pdf" "409","Empaveli","1281","05/14/2021","5482","Patient Safety Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Patient_Safety_Guide.pdf" "409","Empaveli","1281","05/14/2021","5483","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Healthcare_Provider_Brochure.pdf" "409","Empaveli","1281","05/14/2021","5484","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Pharmacy_Enrollment_Form.pdf" "409","Empaveli","1281","05/14/2021","5485","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Prescriber_Enrollment_Form.pdf" "409","Empaveli","1281","05/14/2021","5486","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Document.pdf" "409","Empaveli","1281","05/14/2021","5487","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Full.pdf" "25","Juxtapid","1282","05/27/2021","5488","Letter for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Letter_For_Pharmacists.pdf" "25","Juxtapid","1282","05/27/2021","5489","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1282","05/27/2021","5490","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1282","05/27/2021","5491","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_REMS_Website_Screenshots.pdf" "25","Juxtapid","1282","05/27/2021","5492","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Letter_For_Healthcare_Providers.pdf" "25","Juxtapid","1282","05/27/2021","5493","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Prescription_Authorization_Form.pdf" "25","Juxtapid","1282","05/27/2021","5494","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Patient-Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1282","05/27/2021","5495","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Patient_Guide.pdf" "25","Juxtapid","1282","05/27/2021","5496","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Fact_Sheet.pdf" "25","Juxtapid","1282","05/27/2021","5497","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1282","05/27/2021","5498","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1282","05/27/2021","5499","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_REMS_Document.pdf" "25","Juxtapid","1282","05/27/2021","5500","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2021_05_27_REMS_Full.pdf" "398","Palforzia","1283","05/26/2021","5501","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Program_Website.pdf" "398","Palforzia","1283","05/26/2021","5502","REMS Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Program_Overview_for_Pharmacies.pdf" "398","Palforzia","1283","05/26/2021","5503","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Education_Program_for_Healthcare_Settings.pdf" "398","Palforzia","1283","05/26/2021","5504","Anaphylaxis Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Anaphylaxis_Adverse_Event_Reporting_Form.pdf" "398","Palforzia","1283","05/26/2021","5505","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Pharmacy_Enrollment_Form.pdf" "398","Palforzia","1283","05/26/2021","5506","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Healthcare_Setting_Enrollment_Form.pdf" "398","Palforzia","1283","05/26/2021","5507","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Patient_Enrollment_Form.pdf" "398","Palforzia","1283","05/26/2021","5508","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Prescriber_Enrollment_Form.pdf" "398","Palforzia","1283","05/26/2021","5509","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Document.pdf" "398","Palforzia","1283","05/26/2021","5510","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Full.pdf" "410","Lenalidomide","1285","05/21/2021","5511","Celgene Risk Management Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Celgene_Risk_Management_Website.pdf" "410","Lenalidomide","1285","05/21/2021","5512","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_REMS_Program_Website.pdf" "410","Lenalidomide","1285","05/21/2021","5513","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "410","Lenalidomide","1285","05/21/2021","5514","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient_Resource_Pack_Envelope.pdf" "410","Lenalidomide","1285","05/21/2021","5515","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Emergency_Contraception_Brochure.pdf" "410","Lenalidomide","1285","05/21/2021","5516","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient_Guide.pdf" "410","Lenalidomide","1285","05/21/2021","5517","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Pharmacy_Certification_Quiz.pdf" "410","Lenalidomide","1285","05/21/2021","5518","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_REMS_Program_Pharmacy_Training.pdf" "410","Lenalidomide","1285","05/21/2021","5519","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Pharmacy_Guide.pdf" "410","Lenalidomide","1285","05/21/2021","5520","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_REMS_Education_and_Prescribing_Safety_Kit.pdf" "410","Lenalidomide","1285","05/21/2021","5521","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Prescriber_Guide.pdf" "410","Lenalidomide","1285","05/21/2021","5522","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Welcome_Letter.pdf" "410","Lenalidomide","1285","05/21/2021","5523","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Male_Child.pdf" "410","Lenalidomide","1285","05/21/2021","5524","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Adult_Male.pdf" "410","Lenalidomide","1285","05/21/2021","5525","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1285","05/21/2021","5526","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1285","05/21/2021","5527","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1285","05/21/2021","5528","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1285","05/21/2021","5529","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_Prescriber_Enrollment_Form.pdf" "410","Lenalidomide","1285","05/21/2021","5530","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_REMS_Document.pdf" "410","Lenalidomide","1285","05/21/2021","5531","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_05_21_REMS_Full.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5532","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_REMS_Full.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5533","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_REMS_Website_Screenshots.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5534","Change in Reproductive Status and PrePubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Change_in_Reproductive_Status_and_PrePubertal_Annual_Verification_Form.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5535","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Guide_for_Female_Patients.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5536","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Prescriber_and_Pharmacy_Guide.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5537","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Inpatient_Pharmacy_Enrollment_Form.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5538","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Outpatient_Pharmacy_Enrollment_Form.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5539","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Patient_Enrollment_and_Consent_Form .pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5540","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_Prescriber_Enrollment_and_Agreement_Form.pdf" "396","Ambrisentan Shared System","1286","06/08/2021","5541","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ambrisentan_Shared_System_2021_06_08_REMS_Document.pdf" "314","Myalept","1287","06/09/2021","5542","REMS Program Website (www.MYALEPTREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_REMS_Program_Website_(www.MYALEPTREMS.com).pdf" "314","Myalept","1287","06/09/2021","5543","REMS Letter for Health Care Providers (Infections)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_REMS_Letter_for_Health_Care_Providers_(Infections).pdf" "314","Myalept","1287","06/09/2021","5544","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_Prescripton_Authorization_Form.pdf" "314","Myalept","1287","06/09/2021","5545","Myalept REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_Myalept_REMS_Program_An_Introduction.pdf" "314","Myalept","1287","06/09/2021","5546","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_Prescriber_Training_Module.pdf" "314","Myalept","1287","06/09/2021","5547","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_Prescriber_Enrollment_Form.pdf" "314","Myalept","1287","06/09/2021","5548","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_REMS_Document.pdf" "314","Myalept","1287","06/09/2021","5549","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2021_06_09_REMS_Full.pdf" "368","Kymriah","1288","06/11/2021","5550","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_REMS_Full.pdf" "368","Kymriah","1288","06/11/2021","5551","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_REMS_Document.pdf" "368","Kymriah","1288","06/11/2021","5552","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_Hospital_Enrollment_Form.pdf" "368","Kymriah","1288","06/11/2021","5553","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_Patient_Wallet_Card.pdf" "368","Kymriah","1288","06/11/2021","5554","Live Program Training Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_Live_Program_Training_Slides.pdf" "368","Kymriah","1288","06/11/2021","5555","Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_Program_Knowledge_Assessment.pdf" "368","Kymriah","1288","06/11/2021","5556","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2021_06_11_REMS_Website_Screenshots.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5567","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_REMS_Program_Website.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5568","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5569","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_Program_Training.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5570","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5571","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5572","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_REMS_document.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5573","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_REMS_Full.pdf" "375","Yescarta and Tecartus","1290","07/14/2021","5574","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_07_14_Adverse_Reaction_Management_Guide.pdf" "313","Aveed","1291","06/28/2021","5575","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_REMS_Website_Screenshots.pdf" "313","Aveed","1291","06/28/2021","5576","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_Education_Program_for_Healthcare_Settings.pdf" "313","Aveed","1291","06/28/2021","5577","What You Need to Know About Aveed Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.pdf" "313","Aveed","1291","06/28/2021","5578","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_REMS_Program_An_Introduction.pdf" "313","Aveed","1291","06/28/2021","5579","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_Knowledge_Assessment.pdf" "313","Aveed","1291","06/28/2021","5580","Education Program for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_Education_Program_for_Healthcare_Providers.pdf" "313","Aveed","1291","06/28/2021","5581","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_Healthcare_Setting_Enrollment_Form.pdf" "313","Aveed","1291","06/28/2021","5582","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_Healthcare_Provider_Enrollment_Form.pdf" "313","Aveed","1291","06/28/2021","5583","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_REMS_Full.pdf" "313","Aveed","1291","06/28/2021","5584","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2021_06_28_REMS_Document.pdf" "351","Clozapine","1292","07/29/2021","5585","REMS Program Website (www.clozapineREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_REMS_Program_Website_(www.clozapineREMS.com).pdf" "351","Clozapine","1292","07/29/2021","5586","Important Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Important_Program_Update.pdf" "351","Clozapine","1292","07/29/2021","5587","Website Pop-Up Message 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Website_Pop-Up_Message_2.pdf" "351","Clozapine","1292","07/29/2021","5588","Website Pop-Up Message 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Website_Pop-Up_Message_1.pdf" "351","Clozapine","1292","07/29/2021","5589","Factsheet: What's Changed with the Clozapine REMS Program for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Factsheet_What's_Changed_with_the_Clozapine_REMS_Program_for_Pharmacies.pdf" "351","Clozapine","1292","07/29/2021","5590","Factsheet: What's Changed with the Clozapine REMS Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Factsheet_What's_Changed_with_the_Clozapine_REMS_Program_for_Prescribers.pdf" "351","Clozapine","1292","07/29/2021","5591","Wholesaler-Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Wholesaler-Distributor_Letter.pdf" "351","Clozapine","1292","07/29/2021","5592","Drop-In Summary for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Drop_In_Summary_for_Pharmacies.pdf" "351","Clozapine","1292","07/29/2021","5593","Pharmacy Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Pharmacy_Professional_Society_Letter.pdf" "351","Clozapine","1292","07/29/2021","5594","Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Pharmacy_Letter.pdf" "351","Clozapine","1292","07/29/2021","5595","Drop-In Summary for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Drop_In_Summary_for_Healthcare_Providers.pdf" "351","Clozapine","1292","07/29/2021","5596","Healthcare Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Healthcare_Professional_Society_Letter.pdf" "351","Clozapine","1292","07/29/2021","5597","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Healthcare_Provider_Letter.pdf" "351","Clozapine","1292","07/29/2021","5598","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_ANC_Lab_Reporting_Form.pdf" "351","Clozapine","1292","07/29/2021","5599","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Patient_Status_Form.pdf" "351","Clozapine","1292","07/29/2021","5600","Knowledge Assessment for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Knowledge_Assessment_for_Pharmacies.pdf" "351","Clozapine","1292","07/29/2021","5601","Clozapine and Risk of Neutropenia: A Guide for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Clozapine_and_Risk_of_Neutropenia_A_Guide_for_Pharmacists.pdf" "351","Clozapine","1292","07/29/2021","5602","A Guide for Patients and Caregivers: What you need to Know about Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_A_Guide_for_Patients_and_Caregivers_What_You_Need_to_Know_about_Clozapine_and_Neutropenia.pdf" "351","Clozapine","1292","07/29/2021","5603","Knowledge Assessment for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Knowledge_Assessment_for_Prescribers.pdf" "351","Clozapine","1292","07/29/2021","5604","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1292","07/29/2021","5605","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1292","07/29/2021","5606","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Outpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1292","07/29/2021","5607","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Patient_Enrollment_Form.pdf" "351","Clozapine","1292","07/29/2021","5608","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1292","07/29/2021","5609","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_REMS_Document.pdf" "351","Clozapine","1292","07/29/2021","5610","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_07_29_REMS_Full.pdf" "41","Pomalyst","1293","08/05/2021","5611","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_REMS_Full.pdf" "41","Pomalyst","1293","08/05/2021","5612","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_REMS_Document .pdf" "41","Pomalyst","1293","08/05/2021","5613","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","1293","08/05/2021","5614","Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant .pdf" "41","Pomalyst","1293","08/05/2021","5615","Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1293","08/05/2021","5616","Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_a_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1293","08/05/2021","5617","Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1293","08/05/2021","5618","Patient-Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_a_Male_Child.pdf" "41","Pomalyst","1293","08/05/2021","5619","Patient-Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Physician_Agreement_Form_for_an_Adult_Male.pdf" "41","Pomalyst","1293","08/05/2021","5620","Patient Resource Packet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Resource_Packet.pdf" "41","Pomalyst","1293","08/05/2021","5621","Patient Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Patient_Guide_to_the_Pomalyst_REMS_Program .pdf" "41","Pomalyst","1293","08/05/2021","5622","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","1293","08/05/2021","5623","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Education_and_Counseling_Checklist_for_Pharmacies .pdf" "41","Pomalyst","1293","08/05/2021","5624","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Celgene_Risk_Management_Website_Screenshots.pdf" "41","Pomalyst","1293","08/05/2021","5625","Celgene REMS Programs Pharmacy Training: the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Celgene_REMS_Programs_Pharmacy_Training_the_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1293","08/05/2021","5626","Prescriber Guide to Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Prescriber_Guide_to_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1293","08/05/2021","5627","Pharmacy Guide to the Pomalyst REMS Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Pharmacy_Guide_to_the_Pomalyst_REMS_Program.pdf" "41","Pomalyst","1293","08/05/2021","5628","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","1293","08/05/2021","5629","Pomalyst REMS Program Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Pomalyst_REMS_Program_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","1293","08/05/2021","5630","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_Welcome_Letter.pdf" "41","Pomalyst","1293","08/05/2021","5631","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2021_08_05_REMS_Program_Website_Screenshots.pdf" "58","Thalomid","1294","08/05/2021","5632","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_REMS_Full.pdf" "58","Thalomid","1294","08/05/2021","5633","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_REMS_Document.pdf" "58","Thalomid","1294","08/05/2021","5634","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Prescriber_Enrollment_Form.pdf" "58","Thalomid","1294","08/05/2021","5635","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","1294","08/05/2021","5636","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "58","Thalomid","1294","08/05/2021","5637","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","1294","08/05/2021","5638","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","1294","08/05/2021","5639","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Adult_Male.pdf" "58","Thalomid","1294","08/05/2021","5640","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Physician_Agreement_Form_for_Male_Child.pdf" "58","Thalomid","1294","08/05/2021","5641","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Welcome_Letter.pdf" "58","Thalomid","1294","08/05/2021","5642","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Prescriber_Guide.pdf" "58","Thalomid","1294","08/05/2021","5643","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_REMS_Education_and_Prescribing_Safety_Kit.pdf" "58","Thalomid","1294","08/05/2021","5644","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Pharmacy_Guide.pdf" "58","Thalomid","1294","08/05/2021","5645","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_REMS_Program_Pharmacy_Training.pdf" "58","Thalomid","1294","08/05/2021","5646","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","1294","08/05/2021","5647","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Guide.pdf" "58","Thalomid","1294","08/05/2021","5648","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Emergency_Contraception_Brochure.pdf" "58","Thalomid","1294","08/05/2021","5649","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","1294","08/05/2021","5650","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "58","Thalomid","1294","08/05/2021","5651","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_REMS_Program_Website_Screenshots.pdf" "58","Thalomid","1294","08/05/2021","5652","Celgene Risk Management Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2021_08_05_Celgene_Risk_Management_Website_Screenshots.pdf" "37","Mycophenolate","1295","08/11/2021","5653","FDA Blueprint for Mycophenolate REMS Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_FDA_ Blueprint_for_Mycophenolate_REMS_Education.pdf" "37","Mycophenolate","1295","08/11/2021","5654","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf" "37","Mycophenolate","1295","08/11/2021","5655","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","1295","08/11/2021","5656","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","1295","08/11/2021","5657","Dear Healthcare Provider Letter for Centers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf" "37","Mycophenolate","1295","08/11/2021","5658","Dear Healthcare Provider Letter for Centers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf" "37","Mycophenolate","1295","08/11/2021","5659","Dear Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Dear_Healthcare_Provider_Letter_2.pdf" "37","Mycophenolate","1295","08/11/2021","5660","Dear Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Dear_Healthcare_Provider_Letter_1.pdf" "37","Mycophenolate","1295","08/11/2021","5661","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Program_Website.pdf" "37","Mycophenolate","1295","08/11/2021","5662","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Website_Banner.pdf" "37","Mycophenolate","1295","08/11/2021","5663","Patient Information Brochure: What You Need to Know About Mycophenolate","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Patient_Information_Brochure_What_You_Need_to_Know_About_Mycophenolate.pdf" "37","Mycophenolate","1295","08/11/2021","5664","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","1295","08/11/2021","5665","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_REMS_Document.pdf" "37","Mycophenolate","1295","08/11/2021","5666","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_08_11_REMS_Full.pdf" "410","Lenalidomide","1296","08/05/2021","5667","Celgene Risk Management Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Celgene_Risk_Management_Website.pdf" "410","Lenalidomide","1296","08/05/2021","5668","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_REMS_Program_Website.pdf" "410","Lenalidomide","1296","08/05/2021","5669","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "410","Lenalidomide","1296","08/05/2021","5670","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient_Resource_Pack_Envelope.pdf" "410","Lenalidomide","1296","08/05/2021","5671","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Emergency_Contraception_Brochure.pdf" "410","Lenalidomide","1296","08/05/2021","5672","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient_Guide.pdf" "410","Lenalidomide","1296","08/05/2021","5673","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Pharmacy_Certification_Quiz.pdf" "410","Lenalidomide","1296","08/05/2021","5674","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_REMS_Program_Pharmacy_Training.pdf" "410","Lenalidomide","1296","08/05/2021","5675","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Pharmacy_Guide.pdf" "410","Lenalidomide","1296","08/05/2021","5676","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_REMS_Education_and_Prescribing_Safety_Kit.pdf" "410","Lenalidomide","1296","08/05/2021","5677","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Prescriber_Guide.pdf" "410","Lenalidomide","1296","08/05/2021","5678","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Welcome_Letter.pdf" "410","Lenalidomide","1296","08/05/2021","5679","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Male_Child.pdf" "410","Lenalidomide","1296","08/05/2021","5680","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Adult_Male.pdf" "410","Lenalidomide","1296","08/05/2021","5681","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1296","08/05/2021","5682","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1296","08/05/2021","5683","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1296","08/05/2021","5684","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1296","08/05/2021","5685","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_Prescriber_Enrollment_Form.pdf" "410","Lenalidomide","1296","08/05/2021","5686","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_REMS_Document.pdf" "410","Lenalidomide","1296","08/05/2021","5687","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2021_08_05_REMS_Full.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5688","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_REMS_Program_Website.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5689","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5690","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5691","Xywav Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xywav_Prescription_Form.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5692","Xyrem Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xyrem_Prescription_Form.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5693","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5694","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5695","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5696","Xywav Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xywav_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5697","Xywav Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xywav_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5698","Xyrem Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xyrem_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5699","Xyrem Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Xyrem_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5700","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5701","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5702","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5703","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_REMS_Document.pdf" "345","Xywav and Xyrem","1297","08/12/2021","5704","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_08_12_REMS_Full.pdf" "382","Copiktra","1298","08/10/2021","5705","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_REMS_Program_Website.pdf" "382","Copiktra","1298","08/10/2021","5706","Patient Safety Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_Patient_Safety_Wallet_Card.pdf" "382","Copiktra","1298","08/10/2021","5707","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_Fact_Sheet.pdf" "382","Copiktra","1298","08/10/2021","5708","Profressional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_Professional Society_REMS_Letter.pdf" "382","Copiktra","1298","08/10/2021","5709","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_Healthcare_Provider_REMS_Letter.pdf" "382","Copiktra","1298","08/10/2021","5710","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_REMS_Document.pdf" "382","Copiktra","1298","08/10/2021","5711","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2021_08_10_REMS_Full.pdf" "376","Sublocade","1299","09/22/2021","5712","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_REMS_Program_Website.pdf" "376","Sublocade","1299","09/22/2021","5713","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1299","09/22/2021","5714","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_Fact_Sheet.pdf" "376","Sublocade","1299","09/22/2021","5715","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_REMS_Full.pdf" "376","Sublocade","1299","09/22/2021","5716","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1299","09/22/2021","5717","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_22_REMS_Document.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5718","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_REMS_Full.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5719","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_REMS_Document.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5720","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5721","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5722","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5723","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5724","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_Program_Training.pdf" "375","Yescarta and Tecartus","1300","10/04/2021","5725","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2021_10_04_REMS_Program_Website.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5726","Non-Compliance Action Policy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Non_Compliance_Action_policy.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5727","Recognizing Pscyhiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Recognizing_Psychiatric_Disorders_in_Adolescents_and_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5728","Office Staff Designees Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Office_Staff_Designees_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5729","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Program_Website.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5730","Website Pop-Up Message","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Website_Pop-Up_Message.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5731","Website Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Website_Program_Update.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5732","Medical Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Medical_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5733","Professional Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Professional_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5734","Pharmacy Representative Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Pharmacy_Representative_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5735","Prescriber Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Prescriber_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5736","Exemptions for Patients with Serious Medical Reasons Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Exemption_for_Patients_with_Serious_Medical_Reasons_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5737","Pharmacist Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5738","Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5739","Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5740","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Fact_Sheet.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5741","Guide for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Guide_for_Patients_Who_Can_Get_pregnant.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5742","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Prescriber_Guide.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5743","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5744","Patient Enrollment Form for Patients Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Patient_Enrollment_Form_for_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5745","Patient Enrollment Form for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Patient_Enrollment_Form_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5746","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5747","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1301","10/08/2021","5748","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Full.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5749","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_REMS_Full.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5750","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_REMS_Document.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5751","Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_Healthcare_Provider_Letter_1.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5752","Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_Healthcare_Provider_Letter_2.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5753","Professional Society Licensing Board Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_Professional_Society_Licensing_Board_Letter_1.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5754","Professional Society Licensing Board Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_Professional_Society_Licensing_Board_Letter_2.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5755","FDA Blueprint","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_FDA_Blueprint.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","5756","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_REMS_Website_Screenshots.pdf" "376","Sublocade","1303","09/30/2021","5757","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_REMS_Program_Website.pdf" "376","Sublocade","1303","09/30/2021","5758","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_Fact_Sheet.pdf" "376","Sublocade","1303","09/30/2021","5759","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1303","09/30/2021","5760","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1303","09/30/2021","5761","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_REMS_Document.pdf" "376","Sublocade","1303","09/30/2021","5762","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2021_09_30_REMS_Full.pdf" "360","Alosetron","1304","10/18/2021","5763","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_REMS_Full.pdf" "360","Alosetron","1304","10/18/2021","5764","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_REMS_Document.pdf" "360","Alosetron","1304","10/18/2021","5765","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_Prescriber_Education_Slide_Deck.pdf" "360","Alosetron","1304","10/18/2021","5766","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_Letter_to_Healthcare_Providers.pdf" "360","Alosetron","1304","10/18/2021","5767","Safety Information Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "360","Alosetron","1304","10/18/2021","5768","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_Patient_Education_Sheet.pdf" "360","Alosetron","1304","10/18/2021","5769","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_REMS_Program_Website_Screenshots.pdf" "360","Alosetron","1304","10/18/2021","5770","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2021_10_18_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5771","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_REMS_Program_Website.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5772","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5773","Emergency Contraceptives Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Emergency_Contraceptives_Brochure.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5774","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient_Guide.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5775","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Pharmacy_Certification_Quiz.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5777","Pharmacy training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Pharmacy_Training.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5778","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Pharmacy_Guide.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5779","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_REMS_Education_and_Prescribing_Safety_Kit.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5780","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Prescriber_Guide.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5781","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Welcome_Letter.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5782","Patient-Prescriber Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Male_Child.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5783","Patient-Prescriber Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Adult_Male.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5784","Patient-Prescriber Agreement Form for Female Child Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Female_Child_Who_Cannot_Get_Pregnant.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5785","Patient-Prescriber Agreement Form for Adult Female Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Adult_Female_Who_Cannot_Get_Pregnant.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5786","Patient-Prescriber Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5787","Patient-Prescriber Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Patient-Prescriber_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5788","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Pharmacy_Enrollment_Form.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5789","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_Prescriber_Enrollment_Form.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5790","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Lenalidomide_2021_10_14_REMS_Document.pdf" "411","PS-Lenalidomide","1305","10/14/2021","5791","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Lenalidomide_2021_10_14_REMS_Full.pdf" "351","Clozapine","1306","11/10/2021","5792","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_REMS_Full.pdf" "351","Clozapine","1306","11/10/2021","5793","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_REMS_Document.pdf" "351","Clozapine","1306","11/10/2021","5794","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1306","11/10/2021","5795","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Patient_Enrollment_Form.pdf" "351","Clozapine","1306","11/10/2021","5796","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Outpatient_Pharmacy_Enrollment_Form .pdf" "351","Clozapine","1306","11/10/2021","5797","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1306","11/10/2021","5798","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1306","11/10/2021","5799","Knowledge Assessment for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Knowledge_Assessment_for_Prescribers .pdf" "351","Clozapine","1306","11/10/2021","5800","A Guide for Patients and Caregivers: What you need to Know about Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_A_Guide_for_Patients_and_Caregivers_What_you_need_to_Know_about_Clozapine_and_Neutropenia .pdf" "351","Clozapine","1306","11/10/2021","5801","Clozapine and Risk of Neutropenia: A Guide for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Pharmacists.pdf" "351","Clozapine","1306","11/10/2021","5802","Knowledge Assessment for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Knowledge_Assessment_for_Pharmacies .pdf" "351","Clozapine","1306","11/10/2021","5803","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Patient_Status_Form .pdf" "351","Clozapine","1306","11/10/2021","5804","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_ANC_Lab_Reporting_Form.pdf" "351","Clozapine","1306","11/10/2021","5805","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Healthcare_Provider_Letter .pdf" "351","Clozapine","1306","11/10/2021","5806","Healthcare Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Healthcare_Professional_Society_Letter .pdf" "351","Clozapine","1306","11/10/2021","5807","Drop-In Summary for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Drop_In_Summary_for_Healthcare_Providers.pdf" "351","Clozapine","1306","11/10/2021","5808","Pharmacy Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Pharmacy_Professional_Society_Letter.pdf" "351","Clozapine","1306","11/10/2021","5809","Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Pharmacy_Letter.pdf" "351","Clozapine","1306","11/10/2021","5810","Drop-In Summary for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Drop_In_Summary_for_Pharmacies.pdf" "351","Clozapine","1306","11/10/2021","5811","Wholesaler-Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Wholesaler_Distributor_Letter.pdf" "351","Clozapine","1306","11/10/2021","5812","Factsheet: What's Changed with the Clozapine REMS Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Factsheet_What_Changed_with_the_Clozapine_REMS_Program_for_Prescribers.pdf" "351","Clozapine","1306","11/10/2021","5813","Website Pop-Up Message 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Website_Pop_Up_Message_1 .pdf" "351","Clozapine","1306","11/10/2021","5814","Factsheet: What's Changed with the Clozapine REMS Program for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Factsheet_What_Changed_with_the_Clozapine_REMS_Program_for_Pharmacies.pdf" "351","Clozapine","1306","11/10/2021","5815","Website Pop-Up Message 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Website_Pop_Up_Message_2.pdf" "351","Clozapine","1306","11/10/2021","5816","Important Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_Important_Program_Update.pdf" "351","Clozapine","1306","11/10/2021","5817","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2021_11_10_REMS_Program_Website_Screenshots.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5818","REMS Website (www.suboxoneREMS.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_REMS_Website_(www.suboxoneREMS.com).pdf" "352","Suboxone/Subutex","1307","11/19/2021","5819","Pharmacists Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_Pharmacists_Brochure_Office-Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Informaition_for_Pharmacists.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5820","Dear Pharmacists Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5821","Prescribers Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_Prescriber_Brochure_Office-Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Informaition_for_Prescribers.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5822","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_REMS_Full.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5823","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5824","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1307","11/19/2021","5825","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_19_REMS_Document.pdf" "385","Ultomiris","1308","11/23/2021","5826","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_Ultomiris_REMS_Program_Website.pdf" "385","Ultomiris","1308","11/23/2021","5827","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_Patient_Safety_Brochure.pdf" "385","Ultomiris","1308","11/23/2021","5828","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_Patient_Safety_Card.pdf" "385","Ultomiris","1308","11/23/2021","5829","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1308","11/23/2021","5830","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1308","11/23/2021","5831","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_REMS_Document.pdf" "385","Ultomiris","1308","11/23/2021","5832","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2021_11_23_REMS_Full.pdf" "403","Blenrep","1309","12/07/2021","5833","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Program_Website.pdf" "403","Blenrep","1309","12/07/2021","5834","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_REMS_Letter_for_Professional_Societies.pdf" "403","Blenrep","1309","12/07/2021","5835","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_REMS_Fact_Sheet.pdf" "403","Blenrep","1309","12/07/2021","5836","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Healthcare_Provider_REMS_Letter.pdf" "403","Blenrep","1309","12/07/2021","5837","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Education_Program_for_Healthcare_Settings.pdf" "403","Blenrep","1309","12/07/2021","5838","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Patient_Guide.pdf" "403","Blenrep","1309","12/07/2021","5839","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Prescriber_Knowledge_Assessment.pdf" "403","Blenrep","1309","12/07/2021","5840","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Education_Program_for_Prescribers.pdf" "403","Blenrep","1309","12/07/2021","5841","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Program_Overview.pdf" "403","Blenrep","1309","12/07/2021","5842","Eye Care Professional Consult Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Eye_Care_Professional_Consult_Request_Form.pdf" "403","Blenrep","1309","12/07/2021","5843","REMS Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_REMS_Checklist.pdf" "403","Blenrep","1309","12/07/2021","5844","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Patient_Status_Form.pdf" "403","Blenrep","1309","12/07/2021","5845","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Healthcare_Setting_Enrollment_Form.pdf" "403","Blenrep","1309","12/07/2021","5846","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Patient_Enrollment_Form.pdf" "403","Blenrep","1309","12/07/2021","5847","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_Prescriber_Enrollment_Form.pdf" "403","Blenrep","1309","12/07/2021","5848","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_REMS_Document.pdf" "403","Blenrep","1309","12/07/2021","5849","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2021_12_07_REMS_Full.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5850","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_Dear_Pharmacist_Letter.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5851","Prescriber Brochure: Office-Based Buprenorphine Therapy for Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_Prescriber_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5852","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_Dear_Prescriber_Letter.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5853","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_Appropriate_Use_Checklist.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5854","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_REMS_Document.pdf" "352","Suboxone/Subutex","1310","11/29/2021","5855","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2021_11_29_REMS_Full.pdf" "37","Mycophenolate","1311","11/16/2021","5856","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf" "37","Mycophenolate","1311","11/16/2021","5857","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","1311","11/16/2021","5858","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","1311","11/16/2021","5859","Dear Healthcare Provider Letter for Centers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf" "37","Mycophenolate","1311","11/16/2021","5860","Dear Healthcare Provider Letter for Centers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf" "37","Mycophenolate","1311","11/16/2021","5861","Dear Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Dear_Healthcare_Provider_Letter_2.pdf" "37","Mycophenolate","1311","11/16/2021","5862","Dear Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Dear_Healthcare_Provider_Letter_1.pdf" "37","Mycophenolate","1311","11/16/2021","5863","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_REMS_Program_Website_Screenshots.pdf" "37","Mycophenolate","1311","11/16/2021","5864","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Website_Banner.pdf" "37","Mycophenolate","1311","11/16/2021","5865","Patient Information Brochure: What You Need to Know About Mycophenolate","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Patient_Information_Brochure_What_You_Need_to_Know_About_Mycophenolate.pdf" "37","Mycophenolate","1311","11/16/2021","5866","Healthcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","1311","11/16/2021","5867","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_REMS_Document.pdf" "37","Mycophenolate","1311","11/16/2021","5868","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_REMS_Full.pdf" "37","Mycophenolate","1311","11/16/2021","5869","FDA Blueprint for Mycophenolate REMS Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2021_11_16_FDA_ Blueprint_for_Mycophenolate_REMS_Education.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5870","Xyrem Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Patient_Quick_Start_Guide_Xyrem.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5871","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_REMS_Full.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5872","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_REMS_Program_Website.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5873","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5874","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5875","Xywav Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Xywav_Prescription_Form.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5876","Xyrem Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Xyrem_Prescription_Form.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5877","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5878","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5879","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5880","Xywav Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Brochure_for_Pediatric_Patients_and_their_Caregivers_Xywav.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5881","Xywav Patient Quickstart Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Patient_Quick_Start_Guide_Xywav.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5882","Xyrem Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Brochure_for_Pediatric_Patients_and_Their_Caregivers_Xyrem.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5883","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5884","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5885","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1312","12/09/2021","5886","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2021_12_09_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5887","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5888","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5889","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5890","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Patient_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5891","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5892","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5893","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5894","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5895","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Patient_Counseling_Guide .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5896","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5897","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Pharmacy_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5898","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Patient_Status_and_Opioid_Tolerance_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5899","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5900","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Patient_ Discontinuation_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5901","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Healthcare_Provider_Letter .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5902","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5903","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5904","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1313","12/03/2021","5905","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2021_12_03_REMS_Program_Website_Screenshots .pdf" "389","Turalio","1314","12/16/2020","5906","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_REMS_Website.pdf" "389","Turalio","1314","12/16/2020","5907","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Letter_for_Professional_Societies.pdf" "389","Turalio","1314","12/16/2020","5908","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1314","12/16/2020","5909","Liver Adverse Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1314","12/16/2020","5910","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Patient_Status_Form.pdf" "389","Turalio","1314","12/16/2020","5911","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Patient_Guide.pdf" "389","Turalio","1314","12/16/2020","5912","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1314","12/16/2020","5913","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Prescriber_Training.pdf" "389","Turalio","1314","12/16/2020","5914","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Program_Overview.pdf" "389","Turalio","1314","12/16/2020","5915","Pharmacy Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Pharmacy_Enrollment.pdf" "389","Turalio","1314","12/16/2020","5916","Patient Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Patient_Enrollment.pdf" "389","Turalio","1314","12/16/2020","5917","Prescriber Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Prescriber_Enrollment_Form.pdf" "389","Turalio","1314","12/16/2020","5918","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_REMS_Document.pdf" "389","Turalio","1314","12/16/2020","5919","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_REMS_Full.pdf" "386","Spravato","1315","01/03/2022","5920","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_REMS_Full.pdf" "386","Spravato","1315","01/03/2022","5921","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_REMS_Document.pdf" "386","Spravato","1315","01/03/2022","5922","Outpatient Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_Outpatient_Healthcare_Setting_ Enrollment_Form.pdf" "386","Spravato","1315","01/03/2022","5923","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_Patient_Enrollment_Form.pdf" "386","Spravato","1315","01/03/2022","5924","Inpatient Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_Inpatient_Healthcare_Setting_Enrollment_Form.pdf" "386","Spravato","1315","01/03/2022","5925","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_Pharmacy_Enrollment_Form.pdf" "386","Spravato","1315","01/03/2022","5926","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_REMS_Program_Overview.pdf" "386","Spravato","1315","01/03/2022","5927","Patient Monitoring Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_Patient_Monitoring_Form.pdf" "386","Spravato","1315","01/03/2022","5928","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2022_01_03_REMS_Program_Website_Screenshots.pdf" "71","Xiaflex","1316","01/11/2022","5929","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_REMS_Full.pdf" "71","Xiaflex","1316","01/11/2022","5930","Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_REMS_Program_Website_Screenshots.pdf" "71","Xiaflex","1316","01/11/2022","5931","What You Need to Know About Xiaflex: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_Patient_Counseling_Tool_What_You_Need_to_Know_About_Xiaflex_A_Patient_Guide.pdf" "71","Xiaflex","1316","01/11/2022","5932","Pharmacy Healthcare Setting Enrollment Form for Peyonie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1316","01/11/2022","5933","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_Healthcare_Provider_Enrollment_Form_for_Peyronies_Disease.pdf" "71","Xiaflex","1316","01/11/2022","5934","Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_Training_Video_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1316","01/11/2022","5935","REMS Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_REMS_Training_Guide_for_Administering_Xiaflex_for_Peyronies_Disease.pdf" "71","Xiaflex","1316","01/11/2022","5936","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_01_11_REMS_Document.pdf" "63","Tysabri","1318","12/10/2021","5957","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Change_Prescriber_Authorization_Form.pdf" "63","Tysabri","1318","12/10/2021","5958","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1318","12/10/2021","5959","6 Month Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_6_Month_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1318","12/10/2021","5960","6 Month Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_6_Month_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1318","12/10/2021","5961","Initial Discontinuation Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Initial_Discontinuation_Questionnaire_CD.pdf" "63","Tysabri","1318","12/10/2021","5962","Initial Discontinuation Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Initial_Discontinuation_Questionnaire_MS.pdf" "63","Tysabri","1318","12/10/2021","5963","Patient Status Report and Reauthorization Questionnaire (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Patient_Status_Report_and_Reauthorization_Questionnaire_CD.pdf" "63","Tysabri","1318","12/10/2021","5964","Patient Status Report and Reauthorization Questionnaire (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Patient_Status_Report_and_Reauthorization_Quetsionnaire_MS.pdf" "63","Tysabri","1318","12/10/2021","5965","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Pre_Infusion_Patient_Checklist.pdf" "63","Tysabri","1318","12/10/2021","5966","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Medication_Guide.pdf" "63","Tysabri","1318","12/10/2021","5967","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1318","12/10/2021","5968","Helpful Information for Evaluation of New Neurological Symptoms in Patients Receiving Tysabri","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Helpful_information_for_evaluation_of_new_neurological_symptoms_in_patients_receiving_Tysabri.pdf" "63","Tysabri","1318","12/10/2021","5969","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_TOUCH_Prescribing_Program_Overview.pdf" "63","Tysabri","1318","12/10/2021","5970","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf" "63","Tysabri","1318","12/10/2021","5971","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1318","12/10/2021","5972","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1318","12/10/2021","5973","Prescriber/Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Prescriber_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1318","12/10/2021","5974","Prescriber/Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_Prescriber_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1318","12/10/2021","5975","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_REMS_Document.pdf" "63","Tysabri","1318","12/10/2021","5976","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2021_12_10_REMS_Full.pdf" "2","Adasuve","1319","01/27/2022","5977","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2022_01_27_REMS_Full.pdf" "2","Adasuve","1319","01/27/2022","5978","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2022_01_27_REMS_Document.pdf" "2","Adasuve","1319","01/27/2022","5979","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2022_01_27_Education_Program_for_Healthcare_Settings.pdf" "2","Adasuve","1319","01/27/2022","5980","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2022_01_27_REMS_Website_Screenshots.pdf" "2","Adasuve","1319","01/27/2022","5981","Healthcare Setting Information and Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2022_01_27_Healthcare_Setting_Information_and_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5982","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Program_Website.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5983","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5984","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5985","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_REMS_Document.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5986","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5987","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Training_Program.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5988","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_Program_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1320","01/25/2022","5989","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_01_25_REMS_Full.pdf" "25","Juxtapid","1321","02/01/2022","5990","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_REMS_Program_Website.pdf" "25","Juxtapid","1321","02/01/2022","5991","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Fact_Sheet.pdf" "25","Juxtapid","1321","02/01/2022","5992","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1321","02/01/2022","5993","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1321","02/01/2022","5994","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1321","02/01/2022","5995","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Prescription_Authorization_Form.pdf" "25","Juxtapid","1321","02/01/2022","5996","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1321","02/01/2022","5997","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Patient_Guide.pdf" "25","Juxtapid","1321","02/01/2022","5998","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1321","02/01/2022","5999","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_REMS_Document.pdf" "25","Juxtapid","1321","02/01/2022","6000","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_02_01_REMS_Full.pdf" "382","Copiktra","1322","02/02/2022","6001","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Program_Website_Screenshots.pdf" "382","Copiktra","1322","02/02/2022","6002","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Fact_Sheet.pdf" "382","Copiktra","1322","02/02/2022","6003","Patient Safety Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Patient_Safety_Wallet_Card.pdf" "382","Copiktra","1322","02/02/2022","6004","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Professional_Society_REMS_Letter.pdf" "382","Copiktra","1322","02/02/2022","6005","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Healthcare_Provider_REMS_Letter.pdf" "382","Copiktra","1322","02/02/2022","6006","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Document.pdf" "382","Copiktra","1322","02/02/2022","6007","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Full.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6008","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_REMS_Program_Website_Screenshots.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6009","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6010","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6011","XYWAV Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYWAY_Prescription_Form.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6012","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6013","XYREM Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYREM_Prescription_Form.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6014","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6015","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6016","XYWAV Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYWAV_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6017","XYWAV Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYWAV_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6018","XYREM Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYREM_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6019","XYREM Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_XYREM_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6020","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6021","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6022","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6023","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_REMS_Document.pdf" "345","Xywav and Xyrem","1323","02/09/2022","6024","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2022_02_09_REMS_Full.pdf" "406","Abecma","1324","04/20/2021","6025","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_Adverse_Reaction_Management_Guide.pdf" "406","Abecma","1324","04/20/2021","6026","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_Knowledge_Assessment.pdf" "406","Abecma","1324","04/20/2021","6027","Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_Training_Program.pdf" "406","Abecma","1324","04/20/2021","6028","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_Patient_Wallet_Card.pdf" "406","Abecma","1324","04/20/2021","6029","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_Hospital_Enrollment_Form.pdf" "406","Abecma","1324","04/20/2021","6030","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_REMS_Document.pdf" "406","Abecma","1324","04/20/2021","6031","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Abecma_2021_04_20_REMS_Full.pdf" "412","Carvykti","1325","02/28/2022","6032","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_REMS_Website.pdf" "412","Carvykti","1325","02/28/2022","6033","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_Adverse_Reaction_Management_Guide.pdf" "412","Carvykti","1325","02/28/2022","6034","Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_REMS_Training_Module.pdf" "412","Carvykti","1325","02/28/2022","6035","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_Patient_Wallet_Card.pdf" "412","Carvykti","1325","02/28/2022","6036","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_Hospital_Enrollment_Form.pdf" "412","Carvykti","1325","02/28/2022","6037","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_REMS_Document.pdf" "412","Carvykti","1325","02/28/2022","6038","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_REMS_Full.pdf" "412","Carvykti","1325","02/28/2022","6039","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2022_02_28_Knowledge_Assessment.pdf" "403","Blenrep","1326","03/02/2022","6040","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Program_Website.pdf" "403","Blenrep","1326","03/02/2022","6041","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Letter_for_Professional_Societies.pdf" "403","Blenrep","1326","03/02/2022","6042","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Fact_Sheet.pdf" "403","Blenrep","1326","03/02/2022","6043","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Healthcare_Provider_REMS_Letter.pdf" "403","Blenrep","1326","03/02/2022","6044","Education Program for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Education_Program_for_Healthcare_Settings.pdf" "403","Blenrep","1326","03/02/2022","6045","REMS Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Patient_Guide.pdf" "403","Blenrep","1326","03/02/2022","6046","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Knowledge_Assessment.pdf" "403","Blenrep","1326","03/02/2022","6047","Education Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Education_Program_for_Prescribers.pdf" "403","Blenrep","1326","03/02/2022","6048","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Program_Overview.pdf" "403","Blenrep","1326","03/02/2022","6049","REMS Eye Care Professional Consult Request Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Eye_Care_Professional_Consult_Request_Form.pdf" "403","Blenrep","1326","03/02/2022","6050","REMS Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Checklist.pdf" "403","Blenrep","1326","03/02/2022","6051","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Patient_Status_Form.pdf" "403","Blenrep","1326","03/02/2022","6052","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Healthcare_Setting_Enrollment_Form.pdf" "403","Blenrep","1326","03/02/2022","6053","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Patient_Enrollment_Form.pdf" "403","Blenrep","1326","03/02/2022","6054","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_Prescriber_Enrollment_Form.pdf" "403","Blenrep","1326","03/02/2022","6055","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Document.pdf" "403","Blenrep","1326","03/02/2022","6056","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2022_03_02_REMS_Full.pdf" "45","Qsymia","1327","03/08/2022","6057","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_REMS_Full.pdf" "45","Qsymia","1327","03/08/2022","6058","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_REMS_Document.pdf" "45","Qsymia","1327","03/08/2022","6059","Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Pharmacy_Enrollment_Form_Corporate_Entity_of_Retail_Chain_Pharmacy .pdf" "45","Qsymia","1327","03/08/2022","6060","Pharmacy Enrollment Form, Independent Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Pharmacy_Enrollment_Form_Independent_Pharmacy.pdf" "45","Qsymia","1327","03/08/2022","6061","Pharmacy Enrollment Form, Mail Order Pharmacy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Pharmacy_Enrollment_Form_Mail_Order_Pharmacy.pdf" "45","Qsymia","1327","03/08/2022","6062","Risk of Birth Defects with Qsymia Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Risk_of_Birth_Defects_with_Qsymia_Patient_Brochure.pdf" "45","Qsymia","1327","03/08/2022","6063","Online Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Online_Qsymia_REMS_Pharmacy_Training_Module.pdf" "45","Qsymia","1327","03/08/2022","6064","Print Qsymia REMS Pharmacy Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Print_Qsymia_REMS_Pharmacy_Training_Module.pdf" "45","Qsymia","1327","03/08/2022","6065","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_Medication_Guide.pdf" "45","Qsymia","1327","03/08/2022","6066","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2022_03_08_REMS_Website_Screenshots.pdf" "17","Opioid Analgesic REMS","1302","04/09/2021","6067","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2021_04_09_Patient_Counseling_Guide.pdf" "321","Zydelig","1328","03/10/2022","6068","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_REMS_Full.pdf" "321","Zydelig","1328","03/10/2022","6069","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_REMS_Document.pdf" "321","Zydelig","1328","03/10/2022","6070","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_REMS_Letter_to_Healthcare_Providers.pdf" "321","Zydelig","1328","03/10/2022","6071","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_REMS_Letter_for_Professional_Societies.pdf" "321","Zydelig","1328","03/10/2022","6072","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_Fact_Sheet.pdf" "321","Zydelig","1328","03/10/2022","6073","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_Patient_Safety_Information_Card.pdf" "321","Zydelig","1328","03/10/2022","6074","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2022_03_10_Journal_Information_Piece.pdf" "352","Suboxone/Subutex","1310","11/29/2021","6075","Pharmacist Brochure: Office-Based Buprenorphine Therapy for Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2011_11_29_Pharmacist_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf" "400","Fintepla","1329","03/25/2022","6076","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Full.pdf" "400","Fintepla","1329","03/25/2022","6077","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Document.pdf" "400","Fintepla","1329","03/25/2022","6078","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_Enrollment_Form.pdf" "400","Fintepla","1329","03/25/2022","6079","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Enrollment_Form.pdf" "400","Fintepla","1329","03/25/2022","6080","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Outpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1329","03/25/2022","6081","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Program_Overview.pdf" "400","Fintepla","1329","03/25/2022","6082","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_Training .pdf" "400","Fintepla","1329","03/25/2022","6083","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Inpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1329","03/25/2022","6084","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_ Knowledge_Assessment.pdf" "400","Fintepla","1329","03/25/2022","6085","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Pharmacy_Guide .pdf" "400","Fintepla","1329","03/25/2022","6086","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Status_ Form.pdf" "400","Fintepla","1329","03/25/2022","6087","Patient Caregiver Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Caregiver_ Guide.pdf" "400","Fintepla","1329","03/25/2022","6088","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Letter_for_Healthcare_Providers.pdf" "400","Fintepla","1329","03/25/2022","6089","Cardiovascular Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Cardiovascular_Adverse_Event_Reporting_Form.pdf" "400","Fintepla","1329","03/25/2022","6090","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Program_Website_Screenshots.pdf" "383","Tegsedi","1330","03/31/2022","6091","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_REMS_Full.pdf" "383","Tegsedi","1330","03/31/2022","6093","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_REMS_Document.pdf" "383","Tegsedi","1330","03/31/2022","6094","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1330","03/31/2022","6095","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Patient_Enrollment_Form.pdf" "383","Tegsedi","1330","03/31/2022","6096","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_REMS_Program_Overview.pdf" "383","Tegsedi","1330","03/31/2022","6097","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Prescriber_Training.pdf" "383","Tegsedi","1330","03/31/2022","6098","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_3_Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1330","03/31/2022","6099","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1330","03/31/2022","6100","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Patient_Wallet_Card.pdf" "383","Tegsedi","1330","03/31/2022","6101","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Patient_Status_Form.pdf" "383","Tegsedi","1330","03/31/2022","6102","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_Patient_Guide.pdf" "383","Tegsedi","1330","03/31/2022","6103","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_03_31_REMS_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6104","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6106","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6107","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Patient_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6108","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6109","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6110","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6111","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6112","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Patient_Counseling_Guide.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6113","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6114","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Pharmacy_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6115","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Patient_Status_and_Opioid_Tolerance_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6116","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6117","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Patient_Discontinuation_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6118","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6119","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6120","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6121","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6122","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_REMS_Program_Website_Screenshots.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6123","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_REMS_Full.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6124","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Knowledge_Assessment.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6125","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_REMS_Document.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6126","Program Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Program_Training.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6127","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Adverse_Reaction_Management_Guide.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6128","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Patient_Wallet_Card.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6129","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Hospital_Enrollment_Form.pdf" "375","Yescarta and Tecartus","1332","04/01/2022","6130","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Yescarta_and_Tecartus_2022_04_01_Program_Website.pdf" "384","Dsuvia","1333","04/21/2022","6131","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2022_04_21_REMS_Full.pdf" "384","Dsuvia","1333","04/21/2022","6132","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2022_04_21_REMS_Document.pdf" "384","Dsuvia","1333","04/21/2022","6133","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2022_04_21_Healthcare_Setting_Enrollment_Form.pdf" "384","Dsuvia","1333","04/21/2022","6134","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2022_04_22_REMS_Website_Screenshots.pdf" "395","Bosentan","1334","04/29/2022","6135","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Website_Screenshots.pdf" "395","Bosentan","1334","04/29/2022","6136","Testing and Patient Counseling Reporting","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Testing_and_Patient_Counseling_Reporting_Form.pdf" "395","Bosentan","1334","04/29/2022","6137","Change in Reproductive Potential Status and Prepubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Change_in_Reproductive_Potential_Status_and_Prepubertal_Annual_Verification_Form.pdf" "395","Bosentan","1334","04/29/2022","6138","Guide for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Guide_For_Patients.pdf" "395","Bosentan","1334","04/29/2022","6139","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Pharmacy_Guide.pdf" "395","Bosentan","1334","04/29/2022","6140","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Fact_Sheet.pdf" "395","Bosentan","1334","04/29/2022","6141","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Prescriber_Guide.pdf" "395","Bosentan","1334","04/29/2022","6142","Inpatient Pharmacy Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Inpatient_Pharmacy_Enrollment_Form.pdf" "395","Bosentan","1334","04/29/2022","6143","Chain Pharmacy Headquarters Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Chain_Pharmacy_Headquarters_Enrollment_Form.pdf" "395","Bosentan","1334","04/29/2022","6144","Outpatient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Outpatient_Enrollment_Form.pdf" "395","Bosentan","1334","04/29/2022","6145","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Patient_Enrollment_Form.pdf" "395","Bosentan","1334","04/29/2022","6146","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_Prescriber_Enrollment_Form.pdf" "395","Bosentan","1334","04/29/2022","6147","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_REMS_Document.pdf" "395","Bosentan","1334","04/29/2022","6148","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Bosentan_2022_04_29_REMS_Full.pdf" "385","Ultomiris","1335","04/27/2022","6149","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_04_27_REMS_Full.pdf" "385","Ultomiris","1335","04/27/2022","6150","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_04_27_REMS_Website_Screenshots.pdf" "385","Ultomiris","1335","04/27/2022","6151","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_202_04_27_Patient_Safety_Brochure.pdf" "385","Ultomiris","1335","04/27/2022","6152","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_202_04_27_Patient_Safety_Card.pdf" "385","Ultomiris","1335","04/27/2022","6153","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_04_27_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1335","04/27/2022","6154","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_04_27_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1335","04/27/2022","6155","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_04_27_REMS_Document.pdf" "413","Camzyos","1336","04/28/2022","6156","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1336","04/28/2022","6159","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_REMS_Program_Website_Screenshots.pdf" "413","Camzyos","1336","04/28/2022","6160","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Patient_Status_Form.pdf" "413","Camzyos","1336","04/28/2022","6161","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Patient_Brochure.pdf" "413","Camzyos","1336","04/28/2022","6162","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1336","04/28/2022","6163","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1336","04/28/2022","6164","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Program_Overview.pdf" "413","Camzyos","1336","04/28/2022","6165","Education Program for Healthcare Providers and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1336","04/28/2022","6166","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1336","04/28/2022","6167","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1336","04/28/2022","6168","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_Patient_Enrollment_Form.pdf" "413","Camzyos","1336","04/28/2022","6169","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_REMS_Document.pdf" "413","Camzyos","1336","04/28/2022","6170","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_04_28_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6171","REMS Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_REMS_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6172","Pharmacist Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_Pharmacist_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6173","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_Prescriber_Brochure.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6174","Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6175","Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6176","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6177","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1338","05/03/2022","6178","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_05_03_REMS_Full.pdf" "360","Alosetron","1339","05/05/2022","6179","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_REMS_Full.pdf" "360","Alosetron","1339","05/05/2022","6180","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_REMS_Document.pdf" "360","Alosetron","1339","05/05/2022","6181","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_Prescriber_Education_Slide_Deck.pdf" "360","Alosetron","1339","05/05/2022","6182","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_Letter_to_Healthcare_Providers.pdf" "360","Alosetron","1339","05/05/2022","6183","Safety Information Fact Sheet for Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_Safety_Information_Fact_Sheet_for_Providers.pdf" "360","Alosetron","1339","05/05/2022","6184","Patient Education Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_Patient_Education_Sheet .pdf" "360","Alosetron","1339","05/05/2022","6185","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_Prescriber_Completion_of_Alosetron REMS_Program_Training_Form.pdf" "360","Alosetron","1339","05/05/2022","6186","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_05_REMS_Program_Website _Screenshots.pdf" "43","Prolia","1341","05/19/2022","6187","Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_REMS_Website_Screenshot.pdf" "43","Prolia","1341","05/19/2022","6188","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_Journal_Information_Piece.pdf" "43","Prolia","1341","05/19/2022","6189","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_Patient_Brochure.pdf" "43","Prolia","1341","05/19/2022","6190","Patient Counselng Chart","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_Patient_Counseling_Chart_for_Healthcare_Providers.pdf" "43","Prolia","1341","05/19/2022","6191","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_REMS_Letter_for_Professional_Societies.pdf" "43","Prolia","1341","05/19/2022","6192","REMS Letter for Healthcare Professionals","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_REMS_Letter_for_Healthcare_Providers.pdf" "43","Prolia","1341","05/19/2022","6193","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_REMS_Document.pdf" "43","Prolia","1341","05/19/2022","6194","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2022_05_19_REMS_Full.pdf" "313","Aveed","1342","05/26/2022","6195","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Website.pdf" "313","Aveed","1342","05/26/2022","6196","What You Need to Know About Aveed Treatment: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.pdf" "313","Aveed","1342","05/26/2022","6197","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Program_An_Introduction.pdf" "313","Aveed","1342","05/26/2022","6198","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Knowledge_Assessment.pdf" "313","Aveed","1342","05/26/2022","6199","REMS Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Education_Program_for_Healthcare_Providers.pdf" "313","Aveed","1342","05/26/2022","6200","Healthcare Setting Enrollment Forms","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Healthcare_Setting_Enrollment_Form.pdf" "313","Aveed","1342","05/26/2022","6201","Healthcare Provider Enrollment Forms","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Healthcare_Provider_Enrollment_Form.pdf" "313","Aveed","1342","05/26/2022","6202","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Document.pdf" "313","Aveed","1342","05/26/2022","6203","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Full.pdf" "413","Camzyos","1343","05/26/2022","6204","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Website_Screenshots.pdf" "413","Camzyos","1343","05/26/2022","6205","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1343","05/26/2022","6206","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Patient_Status_Form.pdf" "413","Camzyos","1343","05/26/2022","6207","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1343","05/26/2022","6208","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Patient_Brochure.pdf" "413","Camzyos","1343","05/26/2022","6209","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1343","05/26/2022","6210","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Program_Overview.pdf" "413","Camzyos","1343","05/26/2022","6211","Education Program for Healthcare Providers and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1343","05/26/2022","6212","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1343","05/26/2022","6213","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05-26_Patient_Enrollment_Form.pdf" "413","Camzyos","1343","05/26/2022","6214","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1343","05/26/2022","6215","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Document.pdf" "413","Camzyos","1343","05/26/2022","6216","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Full.pdf" "368","Kymriah","1344","05/27/2022","6217","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_REMS_Full.pdf" "368","Kymriah","1344","05/27/2022","6218","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_REMS_Document.pdf" "368","Kymriah","1344","05/27/2022","6219","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_Hospital_Enrollment_Form.pdf" "368","Kymriah","1344","05/27/2022","6220","Program Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_Program_Knowledge_Assessment.pdf" "368","Kymriah","1344","05/27/2022","6221","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_Patient_Wallet_Card.pdf" "368","Kymriah","1344","05/27/2022","6222","Live Program Training Slides","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_Live_Program_Training_Slides.pdf" "368","Kymriah","1344","05/27/2022","6223","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Kymriah_2022_05_27_REMS_Website_Screenshots.pdf" "360","Alosetron","1345","05/18/2022","6224","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Full.pdf" "360","Alosetron","1345","05/18/2022","6225","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Program_Website_Screenshots.pdf" "360","Alosetron","1345","05/18/2022","6226","Prescriber Completion of Alosetron REMS Program Training Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form.pdf" "360","Alosetron","1345","05/18/2022","6227","Patient Education Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Patient_Education_Fact_Sheet.pdf" "360","Alosetron","1345","05/18/2022","6228","Safety Information Fact Sheet for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Safety_Information_Fact_Sheet_for_Prescribers.pdf" "360","Alosetron","1345","05/18/2022","6229","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Prescriber_Education_Slide_Deck.pdf" "360","Alosetron","1345","05/18/2022","6230","Letter to Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Letter_to_Healthcare_Providers.pdf" "360","Alosetron","1345","05/18/2022","6231","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Document.pdf" "71","Xiaflex","1346","06/09/2022","6232","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_REMS_Full.pdf" "71","Xiaflex","1346","06/09/2022","6233","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_REMS_Document.pdf" "71","Xiaflex","1346","06/09/2022","6234","REMS Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_REMS_Training_Guide_for Administering_Xiaflex_for_Peyronie's_Disease.pdf" "71","Xiaflex","1346","06/09/2022","6235","Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_Training_Video_for_Administering_Xiaflex_for_Peyronie's_Disease.pdf" "71","Xiaflex","1346","06/09/2022","6236","Pharmacy Healthcare Setting Enrollment Form for Peyonie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyonie's_Disease.pdf" "71","Xiaflex","1346","06/09/2022","6237","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_Healthcare_Provider_Enrollment_Form_for_Peyonie's_Disease.pdf" "71","Xiaflex","1346","06/09/2022","6238","What You Need to Know About Xiaflex: A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_What_You_Need_to_Know_About_Xiaflex__A_Patient_Guide.pdf" "71","Xiaflex","1346","06/09/2022","6239","Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_06_09_Program_Website_Screenshots.pdf" "362","Siliq","1347","06/14/2022","6240","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_REMS_Public_Website.pdf" "362","Siliq","1347","06/14/2022","6241","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_Patient_Wallet_Card.pdf" "362","Siliq","1347","06/14/2022","6242","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1347","06/14/2022","6243","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_Patient_Enrollment_Form.pdf" "362","Siliq","1347","06/14/2022","6244","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_Prescriber_Enrollment_Form.pdf" "362","Siliq","1347","06/14/2022","6245","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_REMS_Document.pdf" "362","Siliq","1347","06/14/2022","6246","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2022_06_14_REMS_Full.pdf" "25","Juxtapid","1348","06/16/2022","6247","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_REMS_Program_Website_Screenshots.pdf" "25","Juxtapid","1348","06/16/2022","6248","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Fact_Sheet.pdf" "25","Juxtapid","1348","06/16/2022","6249","Pharmacy Training and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Pharmacy_Training_and_Knowledge_Assessment.pdf" "25","Juxtapid","1348","06/16/2022","6250","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1348","06/16/2022","6251","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1348","06/16/2022","6252","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Prescription_Authorization_Form.pdf" "25","Juxtapid","1348","06/16/2022","6253","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Patient_Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1348","06/16/2022","6254","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Patient_Guide.pdf" "25","Juxtapid","1348","06/16/2022","6255","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1348","06/16/2022","6256","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_REMS_Document.pdf" "25","Juxtapid","1348","06/16/2022","6257","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2022_06_16_REMS_Full.pdf" "387","Zulresso","1349","06/16/2022","6258","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_REMS_Full.pdf" "387","Zulresso","1349","06/16/2022","6259","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_REMS_Document.pdf" "387","Zulresso","1349","06/16/2022","6260","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1349","06/16/2022","6261","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1349","06/16/2022","6262","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Patient_Enrollment_Form.pdf" "387","Zulresso","1349","06/16/2022","6263","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1349","06/16/2022","6264","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Patient_Information_Guide.pdf" "387","Zulresso","1349","06/16/2022","6265","Healthcare Setting Knowledge Assessment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1349","06/16/2022","6266","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Program_Overview.pdf" "387","Zulresso","1349","06/16/2022","6267","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Post_Infusion_Form.pdf" "387","Zulresso","1349","06/16/2022","6268","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1349","06/16/2022","6269","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1349","06/16/2022","6270","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2022_06_16_REMS_Program_Website_Screenshots.pdf" "405","Breyanzi","1350","06/24/2022","6271","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_REMS_Program_Website.pdf" "405","Breyanzi","1350","06/24/2022","6272","REMS Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_REMS_Knowledge_Assessment.pdf" "405","Breyanzi","1350","06/24/2022","6273","Live Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_Live_Training_Program.pdf" "405","Breyanzi","1350","06/24/2022","6274","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_Patient_Wallet_Card.pdf" "405","Breyanzi","1350","06/24/2022","6275","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_Hospital_Enrollment_Form.pdf" "405","Breyanzi","1350","06/24/2022","6276","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_REMS_Document.pdf" "405","Breyanzi","1350","06/24/2022","6277","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2022_06_24_REMS_Full.pdf" "385","Ultomiris","1353","07/22/2022","6278","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_REMS_Full.pdf" "385","Ultomiris","1353","07/22/2022","6279","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_REMS_Document.pdf" "385","Ultomiris","1353","07/22/2022","6280","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1353","07/22/2022","6281","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1353","07/22/2022","6282","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_Patient_Safety_Brochure.pdf" "385","Ultomiris","1353","07/22/2022","6283","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_REMS_Website_Screenshots.pdf" "385","Ultomiris","1353","07/22/2022","6284","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_07_22_Patient_Safety_Card.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1331","03/07/2022","6285","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_03_07_REMS_Document.pdf" "385","Ultomiris","1354","08/03/2022","6286","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS Full.pdf" "385","Ultomiris","1354","08/03/2022","6287","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS_Document.pdf" "385","Ultomiris","1354","08/03/2022","6288","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Prescriber_Enrollment_Form.pdf" "385","Ultomiris","1354","08/03/2022","6289","Prescriber Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Prescriber_Safety_Brochure.pdf" "385","Ultomiris","1354","08/03/2022","6290","Patient Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Patient_Safety_Brochure.pdf" "385","Ultomiris","1354","08/03/2022","6291","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Patient_Safety_Card.pdf" "385","Ultomiris","1354","08/03/2022","6292","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS_Program_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6293","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6294","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6295","Prescriber Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6296","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Enrollment_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6297","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6298","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6299","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6300","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6301","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Counseling_Guide.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6302","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6303","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Pharmacy_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6304","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Status_and_Opioid_Tolerance_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6305","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6306","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Discontinuation_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6307","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6308","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6309","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Inpatient_Pharmacy_Letter .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6310","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1355","08/17/2022","6311","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Program_Website_Screenshots.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6312","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_REMS_Website_Screenshots.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6313","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Change_in_Reproductive_Potential_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6314","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Guide_for_Female_Patients.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6315","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Prescriber_and_Pharmacy_Guide.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6316","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Outpatient_Pharmacy_Enrollment_Form.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6317","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Inpatient_Pharmacy_Enrollment_Form.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6318","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Prescriber_Enrollment_and_Agreement_Form.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6319","Patient Enrollment and Consent Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_Patient_Enrollment_and_Consent_Form.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6320","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_REMS_Document.pdf" "414","Riociguat Shared System REMS","1358","09/01/2022","6321","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Riociguat_2022_09_01_REMS_Full.pdf" "340","Lemtrada","1359","09/02/2022","6322","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_REMS_Full.pdf" "340","Lemtrada","1359","09/02/2022","6323","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_REMS_Document.pdf" "340","Lemtrada","1359","09/02/2022","6324","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1359","09/02/2022","6325","Patient Enrollment and Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Enrollment_and_Prescription_Ordering_Form.pdf" "340","Lemtrada","1359","09/02/2022","6326","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1359","09/02/2022","6327","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1359","09/02/2022","6328","REMS Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_REMS_Education_Program.pdf" "340","Lemtrada","1359","09/02/2022","6329","LEMTRADA Treatment and Infusion Reactions Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_LEMTRADA_Treatment_and_Infusion_Reactions_Patient_Guide.pdf" "340","Lemtrada","1359","09/02/2022","6330","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Prescriber_Knowledge_Assessment.pdf" "340","Lemtrada","1359","09/02/2022","6331","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Status_Form .pdf" "340","Lemtrada","1359","09/02/2022","6332","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1359","09/02/2022","6333","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Authorization_and_Baseline_Lab_Form .pdf" "340","Lemtrada","1359","09/02/2022","6334","Patient Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Letter.pdf" "340","Lemtrada","1359","09/02/2022","6335","REMS Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_REMS_Infusion_Checklist .pdf" "340","Lemtrada","1359","09/02/2022","6336","Patient Transfer of Care Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Patient_Transfer_of_Care_Form .pdf" "340","Lemtrada","1359","09/02/2022","6337","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_Healthcare_Provider_Letter.pdf" "340","Lemtrada","1359","09/02/2022","6338","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2022_09_02_REMS_Program_Website.pdf" "383","Tegsedi","1360","09/14/2022","6340","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_REMS_Website_Screenshots.pdf" "383","Tegsedi","1360","09/14/2022","6341","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_REMS_Program_Overview.pdf" "383","Tegsedi","1360","09/14/2022","6342","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_REMS_Full.pdf" "383","Tegsedi","1360","09/14/2022","6343","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_REMS_Document.pdf" "383","Tegsedi","1360","09/14/2022","6344","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Prescriber_Training.pdf" "383","Tegsedi","1360","09/14/2022","6345","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1360","09/14/2022","6346","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1360","09/14/2022","6347","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Patient_Wallet_Card.pdf" "383","Tegsedi","1360","09/14/2022","6348","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Patient_Status_Form.pdf" "383","Tegsedi","1360","09/14/2022","6349","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Patient_Guide.pdf" "383","Tegsedi","1360","09/14/2022","6350","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1360","09/14/2022","6351","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2022_09_14_Patient_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6352","Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6353","Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6354","Exemptions for Patients with Serious Medical Reasons Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Exemption_for_Patients_with_Serious_Medical_Reasons_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6355","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Fact_Sheet.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6356","Guide for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Guide_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6357","Medical Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Medical_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6358","Non-Compliance Action Policy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Non_Compliance_Action_Policy.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6359","Office Staff Designees Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Office_Staff_Designees_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6360","Patient Enrollment Form for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Patient_Enrollment_Form_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6361","Patient Enrollment Form for Patients Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Patient_Enrollment_Form_for_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6362","Pharmacist Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6363","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6364","Pharmacy Representative Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Pharmacy_Representative_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6365","Prescriber Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Prescriber_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6366","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6367","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Prescriber_Guide.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6368","Professional Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Professional_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6369","Recognizing Pscyhiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Recognizing_Psychiatric_Disorders_in_Adolescents_and_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6370","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6371","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_REMS_Full.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6372","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_REMS_Program_Website.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6373","Website Pop-Up Message","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Website_Pop-Up_Message.pdf" "24","Isotretinoin iPLEDGE","1361","10/06/2022","6374","Website Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2022_10_6_Website_Program_Update.pdf" "389","Turalio","1362","10/14/2022","6375","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_REMS_Website_Screenshots.pdf" "389","Turalio","1362","10/14/2022","6376","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Letter_for_Professional_Societies.pdf" "389","Turalio","1362","10/14/2022","6377","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1362","10/14/2022","6378","Liver Adverse Event Reporting","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1362","10/14/2022","6379","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Patient_Status_Form.pdf" "389","Turalio","1362","10/14/2022","6380","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Patient_Guide.pdf" "389","Turalio","1362","10/14/2022","6381","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1362","10/14/2022","6382","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Prescriber_Training.pdf" "389","Turalio","1362","10/14/2022","6383","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Program_Overview.pdf" "389","Turalio","1362","10/14/2022","6384","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Pharmacy_Enrollment_Form.pdf" "389","Turalio","1362","10/14/2022","6385","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Patient_Enrollment_Form.pdf" "389","Turalio","1362","10/14/2022","6386","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_Prescriber_Enrollment_Form.pdf" "389","Turalio","1362","10/14/2022","6387","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_REMS_Document.pdf" "389","Turalio","1362","10/14/2022","6388","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2022_10_14_REMS_Full.pdf" "364","Vigabatrin","1363","10/12/2022","6389","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_Website_Screenshots.pdf" "364","Vigabatrin","1363","10/12/2022","6390","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_Patient_Guide.pdf" "364","Vigabatrin","1363","10/12/2022","6391","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_Pharmacy_Enrollment_Form.pdf" "364","Vigabatrin","1363","10/12/2022","6392","Patient/Parent/Legal Guardian-Physician Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_Patient_Parent_Legal_Guardian-Physician_Agreement_Form.pdf" "364","Vigabatrin","1363","10/12/2022","6393","Prescriber Enrollment And Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_Prescriber_Enrollment_And_Agreement_Form.pdf" "364","Vigabatrin","1363","10/12/2022","6394","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_REMS_Document.pdf" "364","Vigabatrin","1363","10/12/2022","6395","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_Shared_System_REMS_2022_10_12_REMS_Full.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6396","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_REMS_Website_Screenshots.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6397","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6398","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6399","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Adverse_Reaction_Management_Guide.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6400","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Prescriber_Training_Program.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6401","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6402","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6403","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6404","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_REMS_Fact_Sheet.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6405","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6406","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6407","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_REMS_Document.pdf" "415","Tecvayli and Talvey","1364","10/25/2022","6408","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_10_25_REMS_Full.pdf" "21","Gattex","1365","10/21/2022","6409","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_REMS_Document.pdf" "21","Gattex","1365","10/21/2022","6410","Patient and Caregiver Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_Patient_and_Caregiver_Counseling_Guide.pdf" "21","Gattex","1365","10/21/2022","6411","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_REMS _Website_Screenshots.pdf" "21","Gattex","1365","10/21/2022","6412","Dear Healthcare Professional Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_Dear_Healthcare_Professional_Letter.pdf" "21","Gattex","1365","10/21/2022","6413","Post Training Knowledge Assessment Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_Post_Training_Knowledge_Assessment_Questions.pdf" "21","Gattex","1365","10/21/2022","6414","Prescriber Education Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_Prescriber_Education_Slide_Deck.pdf" "21","Gattex","1365","10/21/2022","6415","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2022_10_21_22_REMS_Full.pdf" "71","Xiaflex","1366","11/02/2022","6416","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_REMS_Full.pdf" "71","Xiaflex","1366","11/02/2022","6417","Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_Program_Website_Screenshots.pdf" "71","Xiaflex","1366","11/02/2022","6418","Healthcare Provider Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_Healthcare_Provider_Enrollment_Form_for_Peyronie's_Disease.pdf" "71","Xiaflex","1366","11/02/2022","6419","Pharmacy/Healthcare Setting Enrollment Form for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyronie's_Disease.pdf" "71","Xiaflex","1366","11/02/2022","6420","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_REMS_Document.pdf" "71","Xiaflex","1366","11/02/2022","6421","REMS Training Guide for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_REMS_Training_Guide_for_Administering_Xiaflex_for_Peyronie's_Disease.pdf" "71","Xiaflex","1366","11/02/2022","6422","Training Video for Administering Xiaflex for Peyronie's Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_Training_Video_for_Administering_Xiaflex_for_Peyronie's_Disease.pdf" "71","Xiaflex","1366","11/02/2022","6423","What You Need to Know About Xiaflex A Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2022_11_02_What_You_Need_to_Know_About_Xiaflex_A_Patient_Guide.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6424","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Website_Screenshots.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6425","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6426","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6427","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Adverse_Reaction_Management_Guide.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6428","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Prescriber_Training_Program.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6429","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6430","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6431","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6432","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Fact_Sheet.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6433","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6434","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6435","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Document.pdf" "415","Tecvayli and Talvey","1367","11/08/2022","6436","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6437","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Website_Screenshots.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6438","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6439","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6440","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6441","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6442","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Patient_Discontinuation_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6443","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6444","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Patient_Status_and_Opioid_Tolerance_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6445","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Pharmacy_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6446","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6447","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Patient_Counseling_Guide.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6448","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6449","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6450","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Inpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6451","Outpatient Pharmacy Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Outpatient_Pharmacy_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6452","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Patient_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6453","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6454","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1368","11/22/2022","6455","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_11_22_REMS_Full.pdf" "413","Camzyos","1369","11/22/2022","6456","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Website_Screenshots.pdf" "413","Camzyos","1369","11/22/2022","6457","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1369","11/22/2022","6458","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Patient_Status_Form.pdf" "413","Camzyos","1369","11/22/2022","6459","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1369","11/22/2022","6460","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Patient_Brochure.pdf" "413","Camzyos","1369","11/22/2022","6461","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1369","11/22/2022","6462","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Program_Overview.pdf" "413","Camzyos","1369","11/22/2022","6463","Education Program for Healthcare Providers and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1369","11/22/2022","6464","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1369","11/22/2022","6465","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05-26_Patient_Enrollment_Form.pdf" "413","Camzyos","1369","11/22/2022","6466","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1369","11/22/2022","6467","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Document.pdf" "413","Camzyos","1369","11/22/2022","6468","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6469","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_REMS_Full.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6470","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_REMS_Document.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6471","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Prescriber_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6472","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Patient_Enrollment_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6473","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Outpatient_Pharmacy_Enrollment_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6474","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Inpatient_Pharmacy_Enrollment_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6475","Prescriber Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Prescriber_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6476","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Prescriber_Knowledge_Assessment.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6477","Patient Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Patient_Counseling_Guide.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6478","Pharmacy Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Pharmacy_Education.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6479","Pharmacy Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Pharmacy_Knowledge_Assessment .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6480","Patient Status and Opioid Tolerance Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Patient_Status_and_Opioid_Tolerance_Form .pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6481","Patient Discontinuation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Patient_Discontinuation_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6482","Adverse Events of Special Interest Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Adverse_Events_of_Special_Interest_Reporting_Form.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6483","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Healthcare_Provider_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6484","Outpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Outpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6485","Inpatient Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Inpatient_Pharmacy_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6486","Urgent Notification Regarding TIRF Products Stock Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Urgent_Notification_ Regarding_TIRF_Products_Stock_Letter.pdf" "60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1371","12/08/2022","6487","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_12_08_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6488","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Website_Screenshots.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6489","Pharmacist Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Pharmacist_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6490","Prescriber Brochure: Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Prescriber_Brochure_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6491","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6492","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6493","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6494","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1372","12/16/2022","6495","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2022_12_16_REMS_Full.pdf" "390","Mifepristone","1374","01/03/2023","6496","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Full.pdf" "390","Mifepristone","1374","01/03/2023","6497","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Document.pdf" "390","Mifepristone","1374","01/03/2023","6498","Prescriber Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Prescriber_Agreement_Form_GenBioPro_Inc.pdf" "390","Mifepristone","1374","01/03/2023","6499","Prescriber Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Prescriber_Agreement_Form_Danco_Laboratories_LLC.pdf" "390","Mifepristone","1374","01/03/2023","6500","Patient Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Patient_Agreement_Form.pdf" "390","Mifepristone","1374","01/03/2023","6501","Pharmacy Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Pharmacy_Agreement_Form_Danco_Laboratories.pdf" "390","Mifepristone","1374","01/03/2023","6502","Pharmacy Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Pharmacy_Agreement_Form_GenBioPro_Inc.pdf" "376","Sublocade","1375","01/06/2023","6503","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_Fact_Sheet_How_to_Obtain_Sublocade.pdf" "376","Sublocade","1375","01/06/2023","6504","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1375","01/06/2023","6505","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1375","01/06/2023","6506","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_REMS_Document.pdf" "376","Sublocade","1375","01/06/2023","6507","Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_REMS_Program_Website_Screenshots.pdf" "376","Sublocade","1375","01/06/2023","6508","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_06_REMS_Full.pdf" "413","Camzyos","1376","01/13/2023","6509","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_REMS_Full.pdf" "413","Camzyos","1376","01/13/2023","6510","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_REMS_Document.pdf" "413","Camzyos","1376","01/13/2023","6511","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Patient_Enrollment_Form.pdf" "413","Camzyos","1376","01/13/2023","6512","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1376","01/13/2023","6513","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1376","01/13/2023","6514","Education Program for Healthcare Providers and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1376","01/13/2023","6515","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Program_Overview.pdf" "413","Camzyos","1376","01/13/2023","6516","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Patient_Brochure.pdf" "413","Camzyos","1376","01/13/2023","6517","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1376","01/13/2023","6518","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1376","01/13/2023","6519","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Patient_Status_Form.pdf" "413","Camzyos","1376","01/13/2023","6520","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1376","01/13/2023","6521","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_01_13_Website_Screenshots.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6522","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_REMS_Full.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6523","REMS Program Website (www.MacitentanREMSProgram.com)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_REMS_Program_website_(www.MacitentanREMSProgram.com).pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6524","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_REMS_Document.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6525","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Prescriber_Enrollment_And_Agreement_Form.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6526","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Prescriber_and_Pharmacy_Guide.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6527","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Patient_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6528","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Outpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6529","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Inpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6530","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Guide_for_Female_Patients.pdf" "407","Macitentan-Containing Products","1377","02/01/2023","6531","Change in Reproductive Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan_2023_02_01_Change_in_Reproductive_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "376","Sublocade","1378","01/27/2023","6532","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_Website_Screenshots.pdf" "376","Sublocade","1378","01/27/2023","6533","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_Fact_Sheet.pdf" "376","Sublocade","1378","01/27/2023","6534","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_Healthcare_Provider_Letter.pdf" "376","Sublocade","1378","01/27/2023","6535","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1378","01/27/2023","6536","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_REMS_Document.pdf" "376","Sublocade","1378","01/27/2023","6537","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_01_27_REMS_Full.pdf" "416","Filspari","1379","02/17/2023","6538","Change in Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Change_in_Reproductive_Potential_Status_Form.pdf" "416","Filspari","1379","02/17/2023","6539","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Inpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1379","02/17/2023","6540","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Outpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1379","02/17/2023","6541","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Patient_Enrollment_Form.pdf" "416","Filspari","1379","02/17/2023","6542","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Patient_Guide.pdf" "416","Filspari","1379","02/17/2023","6543","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Prescriber_and_Pharmacy_Guide.pdf" "416","Filspari","1379","02/17/2023","6544","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Prescriber_Enrollment_Form.pdf" "416","Filspari","1379","02/17/2023","6545","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_REMS_Document.pdf" "58","Thalomid","1383","03/24/2023","6581","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Full.pdf" "58","Thalomid","1383","03/24/2023","6582","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Document.pdf" "58","Thalomid","1383","03/24/2023","6583","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Prescriber Enrollment Form .pdf" "58","Thalomid","1383","03/24/2023","6584","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant .pdf" "58","Thalomid","1383","03/24/2023","6585","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "58","Thalomid","1383","03/24/2023","6586","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "58","Thalomid","1383","03/24/2023","6587","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant .pdf" "58","Thalomid","1383","03/24/2023","6588","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Male .pdf" "58","Thalomid","1383","03/24/2023","6589","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Welcome_Letter .pdf" "58","Thalomid","1383","03/24/2023","6590","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Male_Child.pdf" "58","Thalomid","1383","03/24/2023","6591","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Education_and Prescribing_Safety_Kit.pdf" "58","Thalomid","1383","03/24/2023","6592","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Prescriber_Guide.pdf" "58","Thalomid","1383","03/24/2023","6593","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Pharmacy_Guide .pdf" "58","Thalomid","1383","03/24/2023","6594","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Program_Pharmacy_Training .pdf" "58","Thalomid","1383","03/24/2023","6595","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Pharmacy_Certification_Quiz.pdf" "58","Thalomid","1383","03/24/2023","6596","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Emergency_Contraception_Brochure .pdf" "58","Thalomid","1383","03/24/2023","6597","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Guide .pdf" "58","Thalomid","1383","03/24/2023","6598","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Resource_Pack_Envelope.pdf" "58","Thalomid","1383","03/24/2023","6599","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "58","Thalomid","1383","03/24/2023","6600","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Program_Website_Screenshots.pdf" "58","Thalomid","1383","03/24/2023","6601","BMS REMS Patient Safety Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_BMS_REMS_Patient_Safety_Website.pdf" "410","Lenalidomide","1384","03/24/2023","6602","BMS REMS Patient Safety Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_BMS_REMS_Patient_Safety_Website.pdf" "410","Lenalidomide","1384","03/24/2023","6603","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Program_Website.pdf" "410","Lenalidomide","1384","03/24/2023","6604","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "410","Lenalidomide","1384","03/24/2023","6605","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Emergency_Contraception_Brochure.pdf" "410","Lenalidomide","1384","03/24/2023","6606","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient_Resource_Pack_Envelope.pdf" "410","Lenalidomide","1384","03/24/2023","6607","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient_Guide.pdf" "410","Lenalidomide","1384","03/24/2023","6608","REMS Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Program_Pharmacy_Training.pdf" "410","Lenalidomide","1384","03/24/2023","6609","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Education_and_Prescribing_Safety_Kit.pdf" "410","Lenalidomide","1384","03/24/2023","6610","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Prescriber_Guide.pdf" "410","Lenalidomide","1384","03/24/2023","6611","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Welcome_Letter.pdf" "410","Lenalidomide","1384","03/24/2023","6612","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Male_Child.pdf" "410","Lenalidomide","1384","03/24/2023","6613","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Adult_Male.pdf" "410","Lenalidomide","1384","03/24/2023","6614","Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1384","03/24/2023","6615","Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "410","Lenalidomide","1384","03/24/2023","6616","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1384","03/24/2023","6617","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "410","Lenalidomide","1384","03/24/2023","6618","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Prescriber_Enrollment_Form.pdf" "410","Lenalidomide","1384","03/24/2023","6619","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Document.pdf" "416","Filspari","1379","02/17/2023","6546","Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_Website_Screenshots.pdf" "416","Filspari","1379","02/17/2023","6547","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/FILSPARI_2023_02_17_REMS_Full.pdf" "387","Zulresso","1380","03/03/2023","6548","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_REMS_Website_Screenshots.pdf" "387","Zulresso","1380","03/03/2023","6549","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1380","03/03/2023","6550","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1380","03/03/2023","6551","Healthcare Setting Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1380","03/03/2023","6552","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1380","03/03/2023","6553","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Patient_Enrollment_Form.pdf" "387","Zulresso","1380","03/03/2023","6554","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Patient_Information_Guide.pdf" "387","Zulresso","1380","03/03/2023","6555","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1380","03/03/2023","6556","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Post_Infusion_Form.pdf" "387","Zulresso","1380","03/03/2023","6557","Program Overview for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Program_Overview_for_Pharmacies.pdf" "387","Zulresso","1380","03/03/2023","6558","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_REMS_Document.pdf" "387","Zulresso","1380","03/03/2023","6559","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1380","03/03/2023","6560","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_03_03_REMS _Full.pdf" "383","Tegsedi","1381","03/08/2023","6561","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_REMS_Document.pdf" "383","Tegsedi","1381","03/08/2023","6562","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_REMS_Full.pdf" "383","Tegsedi","1381","03/08/2023","6563","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_REMS_Website_Screenshots.pdf" "383","Tegsedi","1381","03/08/2023","6564","REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_REMS_Program_Overview.pdf" "383","Tegsedi","1381","03/08/2023","6565","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Prescriber_Training.pdf" "383","Tegsedi","1381","03/08/2023","6566","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1381","03/08/2023","6567","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1381","03/08/2023","6568","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1381","03/08/2023","6569","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Patient_Wallet_Card.pdf" "383","Tegsedi","1381","03/08/2023","6570","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Patient_Status_Form.pdf" "383","Tegsedi","1381","03/08/2023","6571","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Patient_Guide.pdf" "383","Tegsedi","1381","03/08/2023","6572","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Patient_Enrollment_Form.pdf" "383","Tegsedi","1381","03/08/2023","6573","Healthcare Provider Reminder Letter for Patient Status Form Submission","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_03_08_Healthcare Provider_Reminder _Letter_for_Patient_Status_Form.pdf" "390","Mifepristone","1382","03/23/2023","6574","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_REMS_Full.pdf" "390","Mifepristone","1382","03/23/2023","6575","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_REMS_Document.pdf" "390","Mifepristone","1382","03/23/2023","6576","Prescriber Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Prescriber_Agreement_Form_for_Danco_Laboratories_LLC.pdf" "390","Mifepristone","1382","03/23/2023","6577","Prescriber Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Prescriber_Agreement_Form_for_GenBioPro_Inc..pdf" "390","Mifepristone","1382","03/23/2023","6578","Pharmacy Agreement Form for Danco Laboratories, LLC","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Pharmacy_Agreement_Form _for_Danco_Laboratories_LLC.pdf" "390","Mifepristone","1382","03/23/2023","6579","Pharmacy Agreement Form for GenBioPro, Inc.","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Pharmacy_Agreement_Form_for_GenBioPro_Inc..pdf" "390","Mifepristone","1382","03/23/2023","6580","Patient Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Patient_Agreement_Form.pdf" "410","Lenalidomide","1384","03/24/2023","6620","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Full.pdf" "410","Lenalidomide","1384","03/24/2023","6621","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Pharmacy Guide.pdf" "410","Lenalidomide","1384","03/24/2023","6622","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","1385","03/24/2023","6623","BMS REMS Patient Safety Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_BMS_REMS_Patient_Safety_Website.pdf" "41","Pomalyst","1385","03/24/2023","6624","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_REMS_Program_Website.pdf" "41","Pomalyst","1385","03/24/2023","6625","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Education_and_Prescribing_Checklist_for_Pharmacies.pdf" "41","Pomalyst","1385","03/24/2023","6626","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Resource_Pack_Envelope.pdf" "41","Pomalyst","1385","03/24/2023","6627","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Emergency_Contraception_Brochure.pdf" "41","Pomalyst","1385","03/24/2023","6628","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Guide.pdf" "41","Pomalyst","1385","03/24/2023","6629","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Pharmacy_Certification_Quiz.pdf" "41","Pomalyst","1385","03/24/2023","6630","Program Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_REMS_Program_Pharmacy_Training.pdf" "41","Pomalyst","1385","03/24/2023","6631","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Pharmacy_Guide.pdf" "41","Pomalyst","1385","03/24/2023","6632","Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_REMS_Education_and_Prescribing_Safety_Kit.pdf" "41","Pomalyst","1385","03/24/2023","6633","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Prescriber_Guide.pdf" "41","Pomalyst","1385","03/24/2023","6634","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Welcome_Letter.pdf" "41","Pomalyst","1385","03/24/2023","6635","Patient Physician Agreement Form for a Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_a_Male_Child.pdf" "41","Pomalyst","1385","03/24/2023","6636","Patient Physician Agreement Form for an Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_an_Adult_Male.pdf" "41","Pomalyst","1385","03/24/2023","6637","Patient Physician Agreement Form for a Female Child Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_a_Female_Child_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1385","03/24/2023","6638","Patient Physician Agreement Form for an Adult Female Who Can Not Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_an_Adult_Female_Who_Can_Not_Get_Pregnant.pdf" "41","Pomalyst","1385","03/24/2023","6639","Patient Physician Agreement Form for a Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_a_Female_Child_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1385","03/24/2023","6641","Patient Physician Agreement Form for an Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Patient_Physician_Agreement_Form_for_an_Adult_Female_Who_Can_Get_Pregnant.pdf" "41","Pomalyst","1385","03/24/2023","6642","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_Prescriber_Enrollment_Form.pdf" "41","Pomalyst","1385","03/24/2023","6643","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_REMS_Document.pdf" "41","Pomalyst","1385","03/24/2023","6644","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2023_03_24_REMS_Full.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6645","Non-Compliance Action Policy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Non-Compliance_Action_Policy.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6646","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Recognizing_Psychiatric_Disorders_in_Adolescents_And_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6647","Office Staff Designees Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Office_Staff_Designees_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6648","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_REMS_Website_Screenshots.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6649","Website Pop-Up Message","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Website_Pop-Up_Message.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6650","Website Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Website_Program_Update.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6651","Medical Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Medical_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6652","Prescriber Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Prescriber_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6653","Exemption for Patients with Serious Medical Reasons Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Exemption_for_Patients_with_Serious_Medical_Reasons_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6654","Pharmacist Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6655","Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6656","Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6657","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Fact_Sheet.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6658","Guide for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Guide_For_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6659","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Prescriber_Guide.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6660","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6661","Patient Enrollment Form for Patients Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Patient_Enrollment_For_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6662","Patient Enrollment Form for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Patient_Enrollment_Form_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6663","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6664","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1386","03/24/2023","6665","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_03_24_REMS_Full.pdf" "63","Tysabri","1387","04/11/2023","6666","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_REMS_Full.pdf" "63","Tysabri","1387","04/11/2023","6667","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_REMS_Document.pdf" "63","Tysabri","1387","04/11/2023","6668","Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1387","04/11/2023","6669","Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1387","04/11/2023","6670","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1387","04/11/2023","6671","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1387","04/11/2023","6672","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Prescriber_Enrollment_Form.pdf" "63","Tysabri","1387","04/11/2023","6673","TOUCH Prescribing Program Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf" "63","Tysabri","1387","04/11/2023","6674","TOUCH Prescribing Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_TOUCH_Prescribing_Program_Overview.pdf" "63","Tysabri","1387","04/11/2023","6675","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Pre-Infusion_Patient_Checklist.pdf" "63","Tysabri","1387","04/11/2023","6676","Patient Status Report and Reauthorization Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Patient_Status_Report_and_Reauthorization_Questionnaire.pdf" "63","Tysabri","1387","04/11/2023","6677","Initial Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Initial_Discontinuation_Questionnaire.pdf" "63","Tysabri","1387","04/11/2023","6678","6 Month Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_6_Month_Discontinuation_Questionnaire.pdf" "63","Tysabri","1387","04/11/2023","6679","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Helpful_Information_for_Evaluation_of_New _Neurologic_Symptoms_in_Patients_Receiving_Tysabri_MS.pdf" "63","Tysabri","1387","04/11/2023","6680","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Understanding_PML_for_Gastroenterologists_CD.pdf" "63","Tysabri","1387","04/11/2023","6681","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Medication_Guide.pdf" "63","Tysabri","1387","04/11/2023","6682","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1387","04/11/2023","6683","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_11_Change_Prescriber_Authorization_Form .pdf" "11","Caprelsa","1388","04/13/2023","6684","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_Patient_Brochure.pdf" "11","Caprelsa","1388","04/13/2023","6685","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_REMS_Website_Screenshots.pdf" "11","Caprelsa","1388","04/13/2023","6686","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_Pharmacy_Enrollment_Form.pdf" "11","Caprelsa","1388","04/13/2023","6687","Prescriber Training Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_Prescriber_Training_Questions.pdf" "11","Caprelsa","1388","04/13/2023","6688","Prescriber Training Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_Prescriber_Training_Slide_Deck.pdf" "11","Caprelsa","1388","04/13/2023","6689","Prescriber Training Pamphlet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_Prescriber_Training_Pamphlet.pdf" "11","Caprelsa","1388","04/13/2023","6690","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_REMS_Document.pdf" "11","Caprelsa","1388","04/13/2023","6691","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2023_04_13_REMS_Full.pdf" "389","Turalio","1389","04/17/2023","6692","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Website_Screenshots.pdf" "389","Turalio","1389","04/17/2023","6693","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Letter_for_Healthcare_Providers.pdf" "389","Turalio","1389","04/17/2023","6694","Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Letter_for_Professional_Societies.pdf" "389","Turalio","1389","04/17/2023","6695","Liver Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Liver_Adverse_Event_Reporting_Form.pdf" "389","Turalio","1389","04/17/2023","6696","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Enrollment_Form.pdf" "389","Turalio","1389","04/17/2023","6697","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Knowledge_Assessment.pdf" "389","Turalio","1389","04/17/2023","6698","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Training.pdf" "389","Turalio","1389","04/17/2023","6699","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Program_Overview.pdf" "389","Turalio","1389","04/17/2023","6700","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Document.pdf" "389","Turalio","1389","04/17/2023","6701","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Full.pdf" "389","Turalio","1389","04/17/2023","6702","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Guide.pdf" "389","Turalio","1389","04/17/2023","6703","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Status_Form.pdf" "389","Turalio","1389","04/17/2023","6704","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Enrollment_Form.pdf" "389","Turalio","1389","04/17/2023","6705","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1390","04/19/2023","6706","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_REMS_Full.pdf" "63","Tysabri","1390","04/19/2023","6707","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_REMS_Document.pdf" "63","Tysabri","1390","04/19/2023","6708","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Prescriber_Enrollment_Form.pdf" "63","Tysabri","1390","04/19/2023","6709","Patient Enrollment Form (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1390","04/19/2023","6710","Patient Enrollment Form (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1390","04/19/2023","6711","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1390","04/19/2023","6712","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1390","04/19/2023","6713","Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Educational_Slide_Set.pdf" "63","Tysabri","1390","04/19/2023","6714","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Program_Overview.pdf" "63","Tysabri","1390","04/19/2023","6715","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Helpful_Information_for_Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_MS.pdf" "63","Tysabri","1390","04/19/2023","6716","Understanding PML for Gastroenterologists (CD)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Understanding_PML_for_Gastroenterologists_CD.pdf" "63","Tysabri","1390","04/19/2023","6717","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Medication_Guide.pdf" "63","Tysabri","1390","04/19/2023","6718","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Pre-Infusion_Patient_Checklist.pdf" "63","Tysabri","1390","04/19/2023","6719","Patient Status Report and Reauthorization Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Patient_Status_Report_and_Reauthorization_Questionnaire.pdf" "63","Tysabri","1390","04/19/2023","6720","Initial Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Initial_Discontinuation_Questionnaire.pdf" "63","Tysabri","1390","04/19/2023","6721","6 Month Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_6_Month_Discontinuation_Questionnaire.pdf" "63","Tysabri","1390","04/19/2023","6722","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1390","04/19/2023","6723","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_04_19_Change_Prescriber_Authorization_Form.pdf" "417","Thalidomide","1391","04/27/2023","6724","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Full.pdf" "417","Thalidomide","1391","04/27/2023","6725","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Document.pdf" "417","Thalidomide","1391","04/27/2023","6726","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Prescriber_Enrollment_Form.pdf" "417","Thalidomide","1391","04/27/2023","6727","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Enrollment_Form.pdf" "417","Thalidomide","1391","04/27/2023","6728","Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf" "417","Thalidomide","1391","04/27/2023","6729","Patient-Physician Agreement Form for Female Child Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf" "417","Thalidomide","1391","04/27/2023","6730","Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Cannot_Get_Pregnant.pdf" "417","Thalidomide","1391","04/27/2023","6731","Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Female_Child_Who_Cannot_Get_Pregnant.pdf" "417","Thalidomide","1391","04/27/2023","6732","Patient-Physician Agreement Form for Adult Male","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Adult_Male.pdf" "417","Thalidomide","1391","04/27/2023","6733","Patient-Physician Agreement Form for Male Child","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Male_Child.pdf" "417","Thalidomide","1391","04/27/2023","6734","Welcome Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Welocme_Letter.pdf" "417","Thalidomide","1391","04/27/2023","6735","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Prescriber_Guide.pdf" "417","Thalidomide","1391","04/27/2023","6736","REMS Education and Prescribing Safety Kit","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Education_and_Prescribing_Safety_Kit.pdf" "417","Thalidomide","1391","04/27/2023","6737","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Guide.pdf" "417","Thalidomide","1391","04/27/2023","6738","Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Training.pdf" "417","Thalidomide","1391","04/27/2023","6739","Pharmacy Certification Quiz","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Certification_Quiz.pdf" "417","Thalidomide","1391","04/27/2023","6740","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Guide.pdf" "417","Thalidomide","1391","04/27/2023","6741","Emergency Contraception Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Emergency_Contraception_Brochure.pdf" "417","Thalidomide","1391","04/27/2023","6742","Patient Resource Pack Envelope","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Resource_Pack_Envelope.pdf" "417","Thalidomide","1391","04/27/2023","6743","Education and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Education_and_Counseling_Checklist_for_Pharmacies.pdf" "417","Thalidomide","1391","04/27/2023","6744","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Website_Screenshots.pdf" "401","Lumryz","1392","05/01/2023","6745","REMS Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_REMS_Program_Website_Screenshots.pdf" "401","Lumryz","1392","05/01/2023","6746","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Risk_Management_Report.pdf" "401","Lumryz","1392","05/01/2023","6747","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_REMS_Fact_Sheet.pdf" "401","Lumryz","1392","05/01/2023","6748","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Dear_Professional_Society_Letter.pdf" "401","Lumryz","1392","05/01/2023","6749","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Dear_Healthcare_Provider_Letter.pdf" "401","Lumryz","1392","05/01/2023","6750","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Patient_Counseling_Checklist.pdf" "401","Lumryz","1392","05/01/2023","6751","Pharmacy Staff Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Pharmacy_Staff_Knowledge_Assessment.pdf" "401","Lumryz","1392","05/01/2023","6752","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Prescription_Form.pdf" "401","Lumryz","1392","05/01/2023","6753","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Certified_Pharmacy_Training_Program.pdf" "401","Lumryz","1392","05/01/2023","6754","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Patient_Brochure.pdf" "401","Lumryz","1392","05/01/2023","6755","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Prescriber_Brochure.pdf" "401","Lumryz","1392","05/01/2023","6756","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Patient_Enrollment_Form.pdf" "401","Lumryz","1392","05/01/2023","6757","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Pharmacy_Enrollment_Form.pdf" "401","Lumryz","1392","05/01/2023","6758","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Prescriber_Enrollment_Form.pdf" "401","Lumryz","1392","05/01/2023","6759","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_REMS_Document.pdf" "401","Lumryz","1392","05/01/2023","6760","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_REMS_Full.pdf" "401","Lumryz","1392","05/01/2023","6761","Pharmacist Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_05_01_Pharmacist_Staff_Knowledge_Assessment.pdf" "45","Qsymia","1393","05/09/2023","6762","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_REMS_Program_Website.pdf" "45","Qsymia","1393","05/09/2023","6763","Risk of Birth Defects with Qsymia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_Risk_of_Birth_Defects_with_Qsymia.pdf" "45","Qsymia","1393","05/09/2023","6764","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_Medication_Guide.pdf" "45","Qsymia","1393","05/09/2023","6765","Qsymia REMS Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_Qsymia_REMS_Pharmacy_Training.pdf" "45","Qsymia","1393","05/09/2023","6766","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_REMS_Document.pdf" "45","Qsymia","1393","05/09/2023","6767","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_REMS_Full.pdf" "45","Qsymia","1393","05/09/2023","6768","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2023_05_09_Pharmacy_Enrollment_Form.pdf" "412","Carvykti","1394","05/18/2023","6769","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Full.pdf" "412","Carvykti","1394","05/18/2023","6770","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Document.pdf" "412","Carvykti","1394","05/18/2023","6771","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Adverse_Reaction_Management_Guide.pdf" "412","Carvykti","1394","05/18/2023","6772","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Hospital_Enrollment_Form.pdf" "412","Carvykti","1394","05/18/2023","6773","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Knowledge_Assessment.pdf" "412","Carvykti","1394","05/18/2023","6774","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Patient_Wallet_Card .pdf" "412","Carvykti","1394","05/18/2023","6775","Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Training_Program.pdf" "412","Carvykti","1394","05/18/2023","6776","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Website.pdf" "418","Brixadi","1395","05/23/2023","6777","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_REMS_Full.pdf" "418","Brixadi","1395","05/23/2023","6778","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_REMS_Document.pdf" "418","Brixadi","1395","05/23/2023","6779","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "418","Brixadi","1395","05/23/2023","6780","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Healthcare_Provider_REMS_Letter.pdf" "418","Brixadi","1395","05/23/2023","6781","Fact Sheet: How to Obtain BRIXADI","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Fact_Sheet_How_to_Obtain_BRIXADI.pdf" "418","Brixadi","1395","05/23/2023","6782","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_REMS_Website_Screenshot.pdf" "400","Fintepla","1396","05/30/2023","6783","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_REMS_Website_Screenshots.pdf" "400","Fintepla","1396","05/30/2023","6784","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Letter_For_Healthcare_Providers.pdf" "400","Fintepla","1396","05/30/2023","6785","Cardiovascular Adverse Event Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Cardiovascular_Adverse_Event_Reporting_Form.pdf" "400","Fintepla","1396","05/30/2023","6786","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Patient_Status_Form.pdf" "400","Fintepla","1396","05/30/2023","6787","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Patient_Guide.pdf" "400","Fintepla","1396","05/30/2023","6788","Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Pharmacy_Guide.pdf" "400","Fintepla","1396","05/30/2023","6789","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Prescriber_Knowledge_Assessment.pdf" "400","Fintepla","1396","05/30/2023","6790","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Prescriber_Training.pdf" "400","Fintepla","1396","05/30/2023","6791","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Program_Overview.pdf" "400","Fintepla","1396","05/30/2023","6792","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Inpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1396","05/30/2023","6793","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Outpatient_Pharmacy_Enrollment_Form.pdf" "400","Fintepla","1396","05/30/2023","6794","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Patient_Enrollment_Form.pdf" "400","Fintepla","1396","05/30/2023","6795","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_Prescriber_Enrollment_Form.pdf" "400","Fintepla","1396","05/30/2023","6796","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_REMS_Document.pdf" "400","Fintepla","1396","05/30/2023","6797","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2023_05_30_REMS_Full.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6798","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Full.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6799","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Document.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6800","FDA Blueprint for Mycophenolate REMS Education","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_10_03_FDA_Blueprint_for_Mycophenolate_REMS_Education.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6801","REMS Letter for Healthcare Providers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter_for _Healthcare_Providers_1.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6802","REMS Letter for Healthcare Providers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter_for _Healthcare_Providers_2.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6803","PS-Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_PS-Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6804","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Patient_Guide.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6806","REMS Letter for Transplant Center Directors 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter _for_Transplant_Center_Directors_1.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6807","REMS Letter for Transplant Center Directors 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter _for_Transplant_Center_Directors_2.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6808","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Website_Banner_Screenshot.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6809","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Website_Screenshot.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6810","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Prescriber_Training_Confirmation_Form.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6811","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Center_Training_Confirmation_Form.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6812","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_REMS_Full.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6813","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_Dear_Healthcare_Provider_Letter.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6814","Prescriber and Pharmacist Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_Prescriber_and_Pharmacist_Information_Brochure.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6815","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_Program_Website.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6816","Hospital Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_Hospital_Pharmacy_Enrollment_Form.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6817","Alvimopan REMS Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_Program_Overview.pdf" "397","Alvimopan Shared System REMS","1398","06/12/2023","6818","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2023_06_12_REMS_Document.pdf" "413","Camzyos","1399","06/15/2023","6819","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_REMS_Website.pdf" "413","Camzyos","1399","06/15/2023","6820","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1399","06/15/2023","6821","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Patient_Status_Form.pdf" "413","Camzyos","1399","06/15/2023","6822","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1399","06/15/2023","6823","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1399","06/15/2023","6824","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Patient_Brochure.pdf" "413","Camzyos","1399","06/15/2023","6825","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Program_Overview.pdf" "413","Camzyos","1399","06/15/2023","6826","Education Program for Healthcare Provider and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1399","06/15/2023","6827","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1399","06/15/2023","6828","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Patient_Enrollment_Form.pdf" "413","Camzyos","1399","06/15/2023","6829","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1399","06/15/2023","6830","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_REMS_Document.pdf" "413","Camzyos","1399","06/15/2023","6831","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_06_15_REMS_Full.pdf" "376","Sublocade","1400","07/03/2023","6832","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_REMS_Website.pdf" "376","Sublocade","1400","07/03/2023","6833","Fact Sheet: How to Obtain SUBLOCADE","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_Fact_Sheet_How_to_Obtain_SUBLOCADE.pdf" "376","Sublocade","1400","07/03/2023","6834","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_Healthcare_Provider_REMS_Letter.pdf" "376","Sublocade","1400","07/03/2023","6835","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "376","Sublocade","1400","07/03/2023","6836","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_REMS_Document.pdf" "376","Sublocade","1400","07/03/2023","6837","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2023_07_03_REMS_Full.pdf" "362","Siliq","1401","07/19/2023","6838","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Slilq_2023_07_19_REMS_Full.pdf" "362","Siliq","1401","07/19/2023","6839","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_REMS_Document.pdf" "362","Siliq","1401","07/19/2023","6840","Prescriber Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_Prescriber_Enrollment_Form.pdf" "362","Siliq","1401","07/19/2023","6841","Pharmacy Enrollment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_Pharmacy_Enrollment_Form.pdf" "362","Siliq","1401","07/19/2023","6842","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_Patient_Wallet_Card.pdf" "362","Siliq","1401","07/19/2023","6843","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_Patient_Enrollment_Form.pdf" "362","Siliq","1401","07/19/2023","6844","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2023_07_19_REMS_Website_Screenshots.pdf" "420","Vanflyta","1402","07/20/2023","6845","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_REMS_Website.pdf" "420","Vanflyta","1402","07/20/2023","6846","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_Knowledge_Assessment.pdf" "420","Vanflyta","1402","07/20/2023","6847","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_Patient_Wallet_Card.pdf" "420","Vanflyta","1402","07/20/2023","6848","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_Prescriber_Training_Program.pdf" "420","Vanflyta","1402","07/20/2023","6849","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_Pharmacy_Enrollment_Form.pdf" "420","Vanflyta","1402","07/20/2023","6850","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_Prescriber_Enrollment_Form.pdf" "420","Vanflyta","1402","07/20/2023","6851","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Vanflyta_2023_07_20_REMS_Full.pdf" "419","PS-Mycophenolate","1397","06/01/2023","6852","Healthcare Provider Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Healthcare_ Provider_Guide.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6853","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_REMS_Full.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6854","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_REMS_Document.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6855","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_REMS_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6856","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Prescriber_Training_Program.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6857","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6858","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6859","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Adverse_Reaction_Management_Guide.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6860","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6861","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6862","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6863","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6864","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_REMS_Website.pdf" "415","Tecvayli and Talvey","1403","08/09/2023","6865","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_08_09_REMS_Fact_Sheet.pdf" "421","Elrexfio","1404","08/14/2023","6866","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_REMS_Full.pdf" "421","Elrexfio","1404","08/14/2023","6867","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_REMS_Document.pdf" "421","Elrexfio","1404","08/14/2023","6868","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Prescriber_Enrollment_Form.pdf" "421","Elrexfio","1404","08/14/2023","6869","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "421","Elrexfio","1404","08/14/2023","6870","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Prescriber_Training_Program.pdf" "421","Elrexfio","1404","08/14/2023","6871","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Knowledge_Assessment.pdf" "421","Elrexfio","1404","08/14/2023","6872","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Adverse_Reaction_Management_Guide.pdf" "421","Elrexfio","1404","08/14/2023","6873","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Patient_Wallet_Card.pdf" "421","Elrexfio","1404","08/14/2023","6874","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "421","Elrexfio","1404","08/14/2023","6875","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Healthcare_Provider_REMS_Letter.pdf" "421","Elrexfio","1404","08/14/2023","6876","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_Professional_Society_REMS_Letter.pdf" "421","Elrexfio","1404","08/14/2023","6877","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_REMS_Fact_Sheet.pdf" "421","Elrexfio","1404","08/14/2023","6878","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_08_14_REMS_Website.pdf" "422","Hepzato","1405","08/14/2023","6879","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_REMS_Full.pdf" "422","Hepzato","1405","08/14/2023","6880","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_REMS_Document.pdf" "422","Hepzato","1405","08/14/2023","6881","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Healthcare_Setting_Enrollment_Form.pdf" "422","Hepzato","1405","08/14/2023","6882","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Program_Overview.pdf" "422","Hepzato","1405","08/14/2023","6883","Didactic Modules","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Didactic_Modules.pdf" "422","Hepzato","1405","08/14/2023","6884","Severe Peri-Procedure-related Complications Adverse Events Documentation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Severe_Peri-Procedure-related_Complications_Adverse_Events_Documentation_Form.pdf" "422","Hepzato","1405","08/14/2023","6885","Criteria for Procedural Competency Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Criteria_for_Procedural_Competency_Checklist.pdf" "422","Hepzato","1405","08/14/2023","6886","Procedure Team Qualification Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_Procedure_Team_Qualification_Status_Form.pdf" "422","Hepzato","1405","08/14/2023","6887","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2023_08_14_REMS_Website.pdf" "314","Myalept","1406","03/31/2023","6888","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_REMS_Full.pdf" "314","Myalept","1406","03/31/2023","6889","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31-REMS_Document.pdf" "314","Myalept","1406","03/31/2023","6890","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_Prescriber_Enrollment_Form.pdf" "314","Myalept","1406","03/31/2023","6891","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_Prescription_Authorization_Form.pdf" "314","Myalept","1406","03/31/2023","6893","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_Prescriber_Training_Module.pdf" "314","Myalept","1406","03/31/2023","6894","Myalept REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_Myalept_REMS_Program_An_Introduction.pdf" "314","Myalept","1406","03/31/2023","6895","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2023_03_31_REMS_Website_Screenshots.pdf" "63","Tysabri","1407","08/24/2023","6896","Change Prescriber Authorization","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Change_Prescriber_Authorization.pdf" "63","Tysabri","1407","08/24/2023","6897","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1407","08/24/2023","6898","6 Month Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_6_Month_Discontinuation_Questionnaire.pdf" "63","Tysabri","1407","08/24/2023","6899","Initial Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Initial_Discontinuation_Questionnaire.pdf" "63","Tysabri","1407","08/24/2023","6900","Patient Status Report and Reauthorization Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Patient_Status_Report_and_Reauthorization_Questionnaire.pdf" "63","Tysabri","1407","08/24/2023","6901","Pre-infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Pre-infusion_Patient_Checklist.pdf" "63","Tysabri","1407","08/24/2023","6902","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Medication_Guide.pdf" "63","Tysabri","1407","08/24/2023","6903","Understanding PML for Gastroenterologists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1407","08/24/2023","6904","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (Multiple Sclerosis)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Helpful_Information_for_Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_Tysabri_MS.pdf" "63","Tysabri","1407","08/24/2023","6905","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Program_Overview.pdf" "63","Tysabri","1407","08/24/2023","6906","Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Educational_Slide_Set.pdf" "63","Tysabri","1407","08/24/2023","6907","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1407","08/24/2023","6908","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1407","08/24/2023","6909","Patient Enrollment Form - Crohn’s Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1407","08/24/2023","6910","Patient Enrollment Form - Multiple Sclerosis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1407","08/24/2023","6911","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_Prescriber_Enrollment_Form.pdf" "63","Tysabri","1407","08/24/2023","6912","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_REMS_Document.pdf" "63","Tysabri","1407","08/24/2023","6913","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_08_24_REMS_Full.pdf" "423","Tyruko","1408","08/24/2023","6914","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Change_in_Prescriber_Authorization_Form.pdf" "423","Tyruko","1408","08/24/2023","6915","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_REMS_Program_Website.pdf" "423","Tyruko","1408","08/24/2023","6916","6-Month Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_6-Month_Discontinuation_Questionnaire.pdf" "423","Tyruko","1408","08/24/2023","6917","Initial Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Initial_Discontinuation_Questionnaire.pdf" "423","Tyruko","1408","08/24/2023","6918","Patient Status Report and Reauthorization Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Patient_Status_Report_and_Reauthorization_Questionnaire.pdf" "423","Tyruko","1408","08/24/2023","6919","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Pre-infusion_Patient_Checklist.pdf" "423","Tyruko","1408","08/24/2023","6920","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Medication_Guide.pdf" "423","Tyruko","1408","08/24/2023","6921","Understanding PML for Gastroenterologists (Crohn’s Disease)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Understanding_PML_for_Gastroenterologists_(CD).pdf" "423","Tyruko","1408","08/24/2023","6922","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving TYRUKO (Multiple Sclerosis)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Helpful_Information_for_Evaluation of New Neurologic_Symptoms_in_Patients_Receiving_TYRUKO_(MS).pdf" "423","Tyruko","1408","08/24/2023","6923","Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Overview.pdf" "423","Tyruko","1408","08/24/2023","6924","Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Educational_Slide_Set.pdf" "423","Tyruko","1408","08/24/2023","6925","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Infusion_Site_Enrollment_Form.pdf" "423","Tyruko","1408","08/24/2023","6926","Patient Enrollment Form (Crohn’s Disease)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Patient_Enrollment_Form-CD.pdf" "423","Tyruko","1408","08/24/2023","6927","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Pharmacy_Enrollment_Form.pdf" "423","Tyruko","1408","08/24/2023","6928","Patient Enrollment Form (Multiple Sclerosis)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Patient_Enrollment_Form-MS.pdf" "423","Tyruko","1408","08/24/2023","6929","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_Prescriber_Enrollment_Form.pdf" "423","Tyruko","1408","08/24/2023","6930","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_REMS_Document.pdf" "423","Tyruko","1408","08/24/2023","6931","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tyruko_2023_08_24_REMS_Full.pdf" "383","Tegsedi","1409","08/24/2023","6932","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Website.pdf" "383","Tegsedi","1409","08/24/2023","6933","Healthcare Provider Reminder Letter for Patient Status Form Submission","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Healthcare_Provider_Reminder_Letter_for_Patient_Status_Form_Submission.pdf" "383","Tegsedi","1409","08/24/2023","6934","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Status_Form.pdf" "383","Tegsedi","1409","08/24/2023","6935","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Wallet_Card.pdf" "383","Tegsedi","1409","08/24/2023","6936","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Guide.pdf" "383","Tegsedi","1409","08/24/2023","6937","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Knowledge_Assessment.pdf" "383","Tegsedi","1409","08/24/2023","6938","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Training.pdf" "383","Tegsedi","1409","08/24/2023","6939","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Pharmacy_Enrollment_Form.pdf" "383","Tegsedi","1409","08/24/2023","6940","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Program_Overview.pdf" "383","Tegsedi","1409","08/24/2023","6941","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Enrollment_Form.pdf" "383","Tegsedi","1409","08/24/2023","6942","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Enrollment_Form.pdf" "383","Tegsedi","1409","08/24/2023","6943","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Document.pdf" "383","Tegsedi","1409","08/24/2023","6944","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Full.pdf" "63","Tysabri","1412","09/01/2023","6945","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_REMS_Document.pdf" "63","Tysabri","1412","09/01/2023","6946","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Prescriber_Enrollment_Form.pdf" "63","Tysabri","1412","09/01/2023","6947","Patient Enrollment Form - Multiple Sclerosis","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Patient_Enrollment_Form_MS.pdf" "63","Tysabri","1412","09/01/2023","6948","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Pharmacy_Enrollment_Form.pdf" "63","Tysabri","1412","09/01/2023","6949","Patient Enrollment Form - Crohn’s Disease","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Patient_Enrollment_Form_CD.pdf" "63","Tysabri","1412","09/01/2023","6950","Infusion Site Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Infusion_Site_Enrollment_Form.pdf" "63","Tysabri","1412","09/01/2023","6951","Educational Slide Set","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Educational_Slide_Set.pdf" "63","Tysabri","1412","09/01/2023","6952","Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Program_Overview.pdf" "63","Tysabri","1412","09/01/2023","6953","Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (Multiple Sclerosis)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Helpful_Information_for_Evaluation_of_New_Neurologic_Symptoms_in_Patients_Receiving_TYSABRI.pdf" "63","Tysabri","1412","09/01/2023","6954","Understanding PML for Gastroenterologists (Crohn’s Disease)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Understanding_PML_for_Gastroenterologists.pdf" "63","Tysabri","1412","09/01/2023","6955","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Medication_Guide.pdf" "63","Tysabri","1412","09/01/2023","6956","Pre-Infusion Patient Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Pre-infusion_Patient_Checklist.pdf" "63","Tysabri","1412","09/01/2023","6957","Patient Status Report and Reauthorization Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Patient_Status_Report_and_Reauthorization_Questionnaire.pdf" "63","Tysabri","1412","09/01/2023","6958","Initial Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Initial_Discontinuation_Questionnaire.pdf" "63","Tysabri","1412","09/01/2023","6959","6-Month Discontinuation Questionnaire","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_6-Month_Discontinuation_Questionnaire.pdf" "63","Tysabri","1412","09/01/2023","6960","REMS Program website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_REMS_Program_Website_Screenshots.pdf" "63","Tysabri","1412","09/01/2023","6961","Change Prescriber Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2023_09_01_Change_Prescriber_Authorization.pdf" "343","Natpara","1413","09/14/2023","6962","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_REMS_Website_Screenshots.pdf" "343","Natpara","1413","09/14/2023","6963","Training Module for Pharmacy Representatives","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Training_Module_For_Pharmacy_Representatives.pdf" "343","Natpara","1413","09/14/2023","6964","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Knowledge_Assessment.pdf" "343","Natpara","1413","09/14/2023","6965","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Patient_Brochure.pdf" "343","Natpara","1413","09/14/2023","6966","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Prescriber_Training_Module.pdf" "343","Natpara","1413","09/14/2023","6967","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Pharmacy_Enrollment_Form.pdf" "343","Natpara","1413","09/14/2023","6968","REMS Program: An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_REMS_Program_An_Introduction.pdf" "343","Natpara","1413","09/14/2023","6969","Patient-Prescriber Acknowledgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Patient-Prescriber_Acknowledgement_Form.pdf" "343","Natpara","1413","09/14/2023","6970","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_Prescriber_Enrollment_Form.pdf" "343","Natpara","1413","09/14/2023","6971","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_REMS_Document.pdf" "343","Natpara","1413","09/14/2023","6972","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2023_09_14_REMS_Full.pdf" "380","Jynarque","1415","09/29/2023","6986","Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Program_Website.pdf" "380","Jynarque","1415","09/29/2023","6987","Liver Adverse Events Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Liver_Adverse_Events_Reporting_Form.pdf" "380","Jynarque","1415","09/29/2023","6988","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Patient_Guide.pdf" "380","Jynarque","1415","09/29/2023","6989","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Patient_Status_Form.pdf" "380","Jynarque","1415","09/29/2023","6990","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Prescriber_Knowledge_Assessment.pdf" "380","Jynarque","1415","09/29/2023","6991","Prescriber Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Prescriber_Training.pdf" "380","Jynarque","1415","09/29/2023","6992","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Program_Overview.pdf" "380","Jynarque","1415","09/29/2023","6993","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Inpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1415","09/29/2023","6994","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Outpatient_Pharmacy_Enrollment_Form.pdf" "380","Jynarque","1415","09/29/2023","6995","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_REMS_Full.pdf" "380","Jynarque","1415","09/29/2023","6996","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Prescriber_Enrollment_Form.pdf" "380","Jynarque","1415","09/29/2023","6997","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_REMS_Document.pdf" "380","Jynarque","1415","09/29/2023","6999","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/JYNARQUE_2023_09_29_Patient_Enrollment_Form.pdf" "351","Clozapine","1417","09/29/2023","7000","Wholesaler-Distributor Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Wholesaler-Distributor_Letter.pdf" "351","Clozapine","1417","09/29/2023","7001","Website Pop-Up Message 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Website_Pop-Up_Message_2.pdf" "351","Clozapine","1417","09/29/2023","7002","Website Pop-Up Message 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Website_Pop-Up_Message_1.pdf" "351","Clozapine","1417","09/29/2023","7003","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_REMS_Program_Website.pdf" "351","Clozapine","1417","09/29/2023","7004","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_REMS_Full.pdf" "351","Clozapine","1417","09/29/2023","7005","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_REMS_Document.pdf" "351","Clozapine","1417","09/29/2023","7006","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Prescriber_Enrollment_Form.pdf" "351","Clozapine","1417","09/29/2023","7007","Pharmacy Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Pharmacy_Professional_Society_Letter.pdf" "351","Clozapine","1417","09/29/2023","7008","Pharmacy Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Pharmacy_Letter.pdf" "351","Clozapine","1417","09/29/2023","7009","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Patient_Status_Form.pdf" "351","Clozapine","1417","09/29/2023","7010","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Patient_Enrollment_Form.pdf" "351","Clozapine","1417","09/29/2023","7011","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Outpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1417","09/29/2023","7012","Knowledge Assessment for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Knowledge_Assessment_for_Prescribers.pdf" "351","Clozapine","1417","09/29/2023","7013","Knowledge Assessment for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Knowledge_Assessment_for_Pharmacies.pdf" "351","Clozapine","1417","09/29/2023","7014","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Inpatient_Pharmacy_Enrollment_Form.pdf" "351","Clozapine","1417","09/29/2023","7015","Important Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Important_Program_Update.pdf" "351","Clozapine","1417","09/29/2023","7016","Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Healthcare_Provider_Letter.pdf" "351","Clozapine","1417","09/29/2023","7017","Healthcare Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Healthcare_Professional_Society_Letter.pdf" "351","Clozapine","1417","09/29/2023","7018","Factsheet: What's Changed with the Clozapine REMS Program for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Factsheet_What's_Changed_with_the_Clozapine_REMS_Program_for_Prescribers.pdf" "351","Clozapine","1417","09/29/2023","7019","Factsheet: What's Changed with the Clozapine REMS Program for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Factsheet_What's_Changed_with_the_Clozapine_REMS_Program_for_Pharmacies.pdf" "351","Clozapine","1417","09/29/2023","7020","Drop In Summary for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Drop_In_Summary_for_Healthcare_Providers.pdf" "351","Clozapine","1417","09/29/2023","7021","Clozapine and the Risk of Neutropenia: A Guide for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Pharmacists.pdf" "351","Clozapine","1417","09/29/2023","7022","Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_Clozapine_and_the_Risk_of_Neutropenia_A_Guide_for_Healthcare_Providers.pdf" "351","Clozapine","1417","09/29/2023","7023","ANC Lab Reporting Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_ANC_Lab_Reporting_Form.pdf" "351","Clozapine","1417","09/29/2023","7024","A Guide for Patients and Caregivers: What you Need to Know about Clozapine and Neutropenia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Clozapine_2023_09_29_A_Guide_for_Patient_and_Caregivers_What_You_Need_to_Know_about_Clozapine_and_Neutropenia.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7026","Non-Compliance Action Policy","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Non-Compliance_Action_Policy.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7027","Recognizing Psychiatric Disorders in Adolescents and Young Adults","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Recognizing_Psychiatric_Disorders_in_Adolescents_and_Young_Adults.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7028","Office Staff Designees Activation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Office_Staff_Designees_Activation_Form.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7029","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_REMS_Program_Website.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7030","Pop-Up Message","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Pop-Up_Message.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7031","Website Program Update","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Website_Program_Update.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7032","Medical Organizations Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Medical_Organizations_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7033","Prescriber Communication Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Prescriber_Communication_Letter.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7034","Exemption for Patients with Serious Medical Reasons Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Exemption_for_Patients_with_Serious_Medical_Reasons_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7035","Pharmacist Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Pharmacist_Guide.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7036","Comprehension Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Comprehension_Questions.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7037","Contraception Counseling Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Contraception_Counseling_Guide.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7038","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Fact_Sheet.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7039","Guide for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Guide_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7040","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Prescriber_Guide.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7041","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Pharmacy_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7042","Patient Enrollment Form for Patients Who Cannot Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Patient_Enrollment_Form_for_Patients_Who_Cannot_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7043","Patient Enrollment Form for Patients Who Can Get Pregnant","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Patient_Enrollment_Form_for_Patients_Who_Can_Get_Pregnant.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7044","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_Prescriber_Enrollment_Form.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7045","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_REMS_Document.pdf" "24","Isotretinoin iPLEDGE","1418","10/03/2023","7046","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2023_10_03_REMS_Full.pdf" "424","Zilbrysq","1419","10/17/2023","7047","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_REMS_Website.pdf" "424","Zilbrysq","1419","10/17/2023","7048","REMS Letter: Vaccination reminder to REMS certified prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_REMS_Letter_Vaccination_reminder_to_REMS_certified_Prescribers.pdf" "424","Zilbrysq","1419","10/17/2023","7049","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_Patient_Guide.pdf" "424","Zilbrysq","1419","10/17/2023","7050","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_Patient_Safety_Card.pdf" "424","Zilbrysq","1419","10/17/2023","7051","Healthcare Provider Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_Healthcare_Provider_Safety_Brochure.pdf" "424","Zilbrysq","1419","10/17/2023","7052","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_Pharmacy_Enrollment_Form.pdf" "424","Zilbrysq","1419","10/17/2023","7053","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_Prescriber_Enrollment_Form.pdf" "424","Zilbrysq","1419","10/17/2023","7054","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_REMS_Document.pdf" "424","Zilbrysq","1419","10/17/2023","7055","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2022_10_17_REMS_Full.pdf" "387","Zulresso","1420","10/17/2023","7056","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_REMS_Program_Website.pdf" "387","Zulresso","1420","10/17/2023","7057","Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Letter_for_Healthcare_Providers.pdf" "387","Zulresso","1420","10/17/2023","7058","Excessive Sedation and Loss of Consciousness Adverse Event Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf" "387","Zulresso","1420","10/17/2023","7059","Post Infusion Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Post_Infusion_Form.pdf" "387","Zulresso","1420","10/17/2023","7060","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Program_Overview.pdf" "387","Zulresso","1420","10/17/2023","7061","Patient Information Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Patient_Information_Guide.pdf" "387","Zulresso","1420","10/17/2023","7062","Healthcare Setting Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Healthcare_Setting_Knowledge_Assessment.pdf" "387","Zulresso","1420","10/17/2023","7063","Training for Healthcare Settings","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Training_for_Healthcare_Settings.pdf" "387","Zulresso","1420","10/17/2023","7064","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Pharmacy_Enrollment_Form.pdf" "387","Zulresso","1420","10/17/2023","7065","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Patient_Enrollment_Form.pdf" "387","Zulresso","1420","10/17/2023","7066","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_Healthcare_Setting_Enrollment_Form.pdf" "387","Zulresso","1420","10/17/2023","7067","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_REMS_Document.pdf" "387","Zulresso","1420","10/17/2023","7068","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2023_10_17_REMS_Full.pdf" "416","Filspari","1421","10/18/2023","7069","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_REMS_Website.pdf" "416","Filspari","1421","10/18/2023","7070","Change in Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Change_in_Reproductive_Potential_Status_Form.pdf" "416","Filspari","1421","10/18/2023","7071","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Patient_Guide.pdf" "416","Filspari","1421","10/18/2023","7072","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Prescriber_and_Pharmacy_Guide.pdf" "416","Filspari","1421","10/18/2023","7073","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Inpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1421","10/18/2023","7074","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Outpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1421","10/18/2023","7075","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Patient_Enrollment_Form.pdf" "416","Filspari","1421","10/18/2023","7076","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_Prescriber_Enrollment_Form.pdf" "416","Filspari","1421","10/18/2023","7077","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_REMS_Document.pdf" "416","Filspari","1421","10/18/2023","7078","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_10_18_REMS_Full.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7079","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7080","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7081","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7082","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_REMS_Fact_Sheet.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7083","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_REMS_Website.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7084","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Adverse_Reaction_Management_Guide.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7085","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7086","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7087","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7088","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_Prescriber_Training_Program.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7089","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_REMS_Document.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7090","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_REMS_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1422","10/20/2023","7091","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_10_20_REMS_Full.pdf" "401","Lumryz","1423","10/31/2023","7092","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_REMS_Full.pdf" "401","Lumryz","1423","10/31/2023","7093","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_REMS_Document.pdf" "401","Lumryz","1423","10/31/2023","7094","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Prescriber_Enrollment_Form.pdf" "401","Lumryz","1423","10/31/2023","7095","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Patient_Enrollment_Form.pdf" "401","Lumryz","1423","10/31/2023","7096","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Pharmacy_Enrollment_Form.pdf" "401","Lumryz","1423","10/31/2023","7097","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Prescriber_Brochure .pdf" "401","Lumryz","1423","10/31/2023","7098","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Patient_Brochure.pdf" "401","Lumryz","1423","10/31/2023","7099","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Certified_Pharmacy_Training_Program.pdf" "401","Lumryz","1423","10/31/2023","7100","Pharmacy Staff Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Pharmacy_Staff_Knowledge_Assessment.pdf" "401","Lumryz","1423","10/31/2023","7101","Pharmacist Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Pharmacist_Knowledge_Assessment.pdf" "401","Lumryz","1423","10/31/2023","7102","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Prescription_Form.pdf" "401","Lumryz","1423","10/31/2023","7103","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Patient_Counseling_Checklist.pdf" "401","Lumryz","1423","10/31/2023","7104","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Dear_Healthcare_Provider_Letter.pdf" "401","Lumryz","1423","10/31/2023","7105","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Dear_Professional_Society_Letter.pdf" "401","Lumryz","1423","10/31/2023","7106","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_REMS_Fact_Sheet.pdf" "401","Lumryz","1423","10/31/2023","7107","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_Risk_Management_Report.pdf" "401","Lumryz","1423","10/31/2023","7108","REMS Program Website Screenshot","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lumryz_2023_10_31_REMS_Program_Website_Screenshot.pdf" "37","Mycophenolate","1424","10/03/2023","7109","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_REMS_Document.pdf" "37","Mycophenolate","1424","10/03/2023","7110","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_REMS_Full.pdf" "37","Mycophenolate","1424","10/03/2023","7111","Heathcare Provider Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Healthcare_Provider_Brochure.pdf" "37","Mycophenolate","1424","10/03/2023","7112","Patient Information Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Patient_Information_Brochure.pdf" "37","Mycophenolate","1424","10/03/2023","7113","Website Banner","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Website_Banner.pdf" "37","Mycophenolate","1424","10/03/2023","7114","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_REMS_Website_Screenshots.pdf" "37","Mycophenolate","1424","10/03/2023","7115","Dear Healthcare Provider Letter 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Dear_Healthcare_Provider_Letter_1.pdf" "37","Mycophenolate","1424","10/03/2023","7116","Dear Healthcare Provider Letter for Centers 1","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf" "37","Mycophenolate","1424","10/03/2023","7117","Dear Healthcare Provider Letter 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Dear_Healthcare_Provider_Letter_2.pdf" "37","Mycophenolate","1424","10/03/2023","7118","Prescriber Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Prescriber_Training_Confirmation_Form.pdf" "37","Mycophenolate","1424","10/03/2023","7119","Dear Healthcare Provider Letter for Centers 2","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf" "37","Mycophenolate","1424","10/03/2023","7120","Center Training Confirmation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Center_Training_Confirmation_Form.pdf" "37","Mycophenolate","1424","10/03/2023","7121","Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf" "37","Mycophenolate","1424","10/03/2023","7122","Mycophenolate REMS Education Blueprint for Healthcare Providers Who Prescribe (FDA Blueprint)","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2023_10_03_FDA_Blueprint_for_Mycophenolate_REMS_Education.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7123","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_REMS_Website.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7124","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_REMS_Fact_Sheet.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7125","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7126","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7127","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7128","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7129","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7130","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Adverse_Reaction_Management_Guide.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7131","Training and Education Materials","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Training_and_Education_Materials.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7132","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7133","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7134","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_REMS_Document.pdf" "415","Tecvayli and Talvey","1425","11/16/2023","7135","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2023_11_16_REMS_Full.pdf" "425","Fabhalta","1426","12/05/2023","7136","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_REMS_Website.pdf" "425","Fabhalta","1426","12/05/2023","7137","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Patient_Safety_Card.pdf" "425","Fabhalta","1426","12/05/2023","7138","Healthcare Provider Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Healthcare_Provider_Safety_Brochure.pdf" "425","Fabhalta","1426","12/05/2023","7139","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Patient_Guide.pdf" "425","Fabhalta","1426","12/05/2023","7140","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Inpatient_Pharmacy_Enrollment_Form.pdf" "425","Fabhalta","1426","12/05/2023","7141","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Outpatient_Pharmacy_Enrollment_Form.pdf" "425","Fabhalta","1426","12/05/2023","7142","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_Prescriber_Enrollment_Form.pdf" "425","Fabhalta","1426","12/05/2023","7143","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_REMS_Document.pdf" "425","Fabhalta","1426","12/05/2023","7144","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Fabhalta_2023_12_05_REMS_Full.pdf" "381","Palynziq","1427","12/09/2023","7145","","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Program_Website.pdf" "381","Palynziq","1427","12/09/2023","7146","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Program_Overview.pdf" "381","Palynziq","1427","12/09/2023","7147","Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Wallet_Card.pdf" "381","Palynziq","1427","12/09/2023","7148","Safety Video","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Safety_Video.pdf" "381","Palynziq","1427","12/09/2023","7149","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Patient_Guide.pdf" "381","Palynziq","1427","12/09/2023","7150","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Prescriber_Knowledge_Assessment.pdf" "381","Palynziq","1427","12/09/2023","7151","Prescriber Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Prescriber_Guide.pdf" "381","Palynziq","1427","12/09/2023","7152","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Pharmacy_Enrollment_Form.pdf" "381","Palynziq","1427","12/09/2023","7153","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Patient_Enrollment_Form.pdf" "381","Palynziq","1427","12/09/2023","7154","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_Prescriber_Enrollment_Form.pdf" "381","Palynziq","1427","12/09/2023","7155","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_REMS_Document.pdf" "381","Palynziq","1427","12/09/2023","7156","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_REMS_Full.pdf" "421","Elrexfio","1428","12/13/2023","7157","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_REMS_Fact_Sheet.pdf" "421","Elrexfio","1428","12/13/2023","7158","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_REMS_Website.pdf" "421","Elrexfio","1428","12/13/2023","7159","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Healthcare_Provider_REMS_Letter.pdf" "421","Elrexfio","1428","12/13/2023","7160","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "421","Elrexfio","1428","12/13/2023","7161","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Professional_Society_REMS_Letter.pdf" "421","Elrexfio","1428","12/13/2023","7162","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Patient_Wallet_Card.pdf" "421","Elrexfio","1428","12/13/2023","7163","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Knowledge_Assessment.pdf" "421","Elrexfio","1428","12/13/2023","7164","Adverse Reaction Management Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Adverse_Reaction_Management_Guide.pdf" "421","Elrexfio","1428","12/13/2023","7165","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Prescriber_Training_Program.pdf" "421","Elrexfio","1428","12/13/2023","7166","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "421","Elrexfio","1428","12/13/2023","7167","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_Prescriber_Enrollment_Form.pdf" "421","Elrexfio","1428","12/13/2023","7168","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_REMS_Document.pdf" "421","Elrexfio","1428","12/13/2023","7169","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Elrexfio_2023_12_13_REMS_Full.pdf" "361","Sodium Oxybate","1429","12/08/2023","7170","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_REMS_Website.pdf" "361","Sodium Oxybate","1429","12/08/2023","7171","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Risk_Management_Report.pdf" "361","Sodium Oxybate","1429","12/08/2023","7172","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_REMS_Fact_Sheet.pdf" "361","Sodium Oxybate","1429","12/08/2023","7173","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Dear_Professional_Society_Letter.pdf" "361","Sodium Oxybate","1429","12/08/2023","7174","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Dear_Healthcare_Provider_Letter.pdf" "361","Sodium Oxybate","1429","12/08/2023","7175","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Patient_Counseling_Checklist.pdf" "361","Sodium Oxybate","1429","12/08/2023","7176","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Prescription_Form.pdf" "361","Sodium Oxybate","1429","12/08/2023","7177","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Module_B_Knowledge_Assessment.pdf" "361","Sodium Oxybate","1429","12/08/2023","7178","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Module_A_Knowledge_Assessment.pdf" "361","Sodium Oxybate","1429","12/08/2023","7179","Certified Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Certified_Pharmacy_Training.pdf" "361","Sodium Oxybate","1429","12/08/2023","7180","Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Patient_Quick_Start_Guide.pdf" "361","Sodium Oxybate","1429","12/08/2023","7181","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Prescriber_Brochure.pdf" "361","Sodium Oxybate","1429","12/08/2023","7182","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Pharmacy_Enrollment_Form.pdf" "361","Sodium Oxybate","1429","12/08/2023","7183","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Patient_Enrollment_Form.pdf" "361","Sodium Oxybate","1429","12/08/2023","7184","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_Prescriber_Enrollment_Form.pdf" "361","Sodium Oxybate","1429","12/08/2023","7185","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_REMS_Document.pdf" "361","Sodium Oxybate","1429","12/08/2023","7186","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2023_12_08_REMS_Full.pdf" "413","Camzyos","1430","12/19/2023","7187","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Website.pdf" "413","Camzyos","1430","12/19/2023","7188","Drug Interaction and Counseling Checklist for Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf" "413","Camzyos","1430","12/19/2023","7189","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Status_Form.pdf" "413","Camzyos","1430","12/19/2023","7190","Pharmacy Authorized Representative Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf" "413","Camzyos","1430","12/19/2023","7191","Healthcare Provider Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Healthcare_Provider_Knowledge_Assessment.pdf" "413","Camzyos","1430","12/19/2023","7192","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Brochure.pdf" "413","Camzyos","1430","12/19/2023","7193","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Program_Overview.pdf" "413","Camzyos","1430","12/19/2023","7194","Education Program for Healthcare Providers and Pharmacies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf" "413","Camzyos","1430","12/19/2023","7195","Healthcare Provider Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Healthcare_Provider_Enrollment_Form.pdf" "413","Camzyos","1430","12/19/2023","7196","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Enrollment_Form.pdf" "413","Camzyos","1430","12/19/2023","7197","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Pharmacy_Enrollment_Form.pdf" "413","Camzyos","1430","12/19/2023","7198","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Document.pdf" "413","Camzyos","1430","12/19/2023","7199","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Full.pdf" "384","Dsuvia","1431","12/19/2023","7200","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Website.pdf" "384","Dsuvia","1431","12/19/2023","7201","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Document.pdf" "384","Dsuvia","1431","12/19/2023","7202","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Full.pdf" "384","Dsuvia","1431","12/19/2023","7203","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_Healthcare_Setting_Enrollment_Form.pdf" "340","Lemtrada","1432","12/15/2023","7204","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_REMS_Program_Website.pdf" "340","Lemtrada","1432","12/15/2023","7205","Patient Letter: Monitoring Reminder","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Letter_Monitoring_Reminder.pdf" "340","Lemtrada","1432","12/15/2023","7206","Healthcare Provider Letter: Monitoring Reminder","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Healthcare_Provider_Letter_Monitoring_Reminder.pdf" "340","Lemtrada","1432","12/15/2023","7207","Patient Transfer of Care Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Transfer_of_Care_Form.pdf" "340","Lemtrada","1432","12/15/2023","7208","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Infusion_Checklist.pdf" "340","Lemtrada","1432","12/15/2023","7209","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Status_Form.pdf" "340","Lemtrada","1432","12/15/2023","7210","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Authorization_and_Baseline_Lab_Form.pdf" "340","Lemtrada","1432","12/15/2023","7211","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1432","12/15/2023","7212","Lemtrada Treatment and Infusion Reaction Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Lemtrada_Treatment_and_Infusion_Reaction_Patient_Guide.pdf" "340","Lemtrada","1432","12/15/2023","7213","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Prescriber_Knowledge_Assessment.pdf" "340","Lemtrada","1432","12/15/2023","7214","REMS Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_REMS_Education_Program.pdf" "340","Lemtrada","1432","12/15/2023","7215","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1432","12/15/2023","7216","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1432","12/15/2023","7217","Patient Enrollment and Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Patient_Enrollment_and_Prescription_Ordering_Form.pdf" "340","Lemtrada","1432","12/15/2023","7218","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1432","12/15/2023","7219","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_REMS_Document.pdf" "340","Lemtrada","1432","12/15/2023","7220","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2023_12_15_REMS_Full.pdf" "416","Filspari","1433","12/20/2023","7221","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_REMS_Website.pdf" "416","Filspari","1433","12/20/2023","7222","Change in Reproductive Potential Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Change_in_Reproductive_Potential_Status_Form.pdf" "416","Filspari","1433","12/20/2023","7223","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Patient_Guide.pdf" "416","Filspari","1433","12/20/2023","7224","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Prescriber_and_Pharmacy_Guide.pdf" "416","Filspari","1433","12/20/2023","7225","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Inpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1433","12/20/2023","7226","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Outpatient_Pharmacy_Enrollment_Form.pdf" "416","Filspari","1433","12/20/2023","7227","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Patient_Enrollment_Form.pdf" "416","Filspari","1433","12/20/2023","7228","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_Prescriber_Enrollment_Form.pdf" "416","Filspari","1433","12/20/2023","7229","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_REMS_Document.pdf" "416","Filspari","1433","12/20/2023","7230","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Filspari_2023_12_20_REMS_Full.pdf" "11","Caprelsa","1434","01/05/2024","7231","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_REMS_Full.pdf" "11","Caprelsa","1434","01/05/2024","7232","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_REMS_Website.pdf" "11","Caprelsa","1434","01/05/2024","7233","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Patient_Brochure.pdf" "11","Caprelsa","1434","01/05/2024","7234","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Pharmacy_Enrollment_Form.pdf" "11","Caprelsa","1434","01/05/2024","7235","Prescriber Enrollment Form Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Prescriber_Enrollment_Form_Screenshots.pdf" "11","Caprelsa","1434","01/05/2024","7236","Prescriber Training Questions","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Prescriber_Training_Questions.pdf" "11","Caprelsa","1434","01/05/2024","7237","Prescriber Training Slide Deck","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Prescriber_Training_Slide_Deck.pdf" "11","Caprelsa","1434","01/05/2024","7238","Prescriber Training Pamphlet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_Prescriber_Training_Pamphlet.pdf" "11","Caprelsa","1434","01/05/2024","7239","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Caprelsa_2024_01_05_REMS_Document.pdf" "424","Zilbrysq","1435","01/16/2024","7240","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_REMS_Full.pdf" "424","Zilbrysq","1435","01/16/2024","7241","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_REMS_Document.pdf" "424","Zilbrysq","1435","01/16/2024","7242","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_Prescriber_Enrollment_Form.pdf" "424","Zilbrysq","1435","01/16/2024","7243","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_Pharmacy_Enrollment_Form.pdf" "424","Zilbrysq","1435","01/16/2024","7244","Healthcare Provider Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_Healthcare_Provider_Safety_Brochure.pdf" "424","Zilbrysq","1435","01/16/2024","7245","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_Patient_Safety_Card.pdf" "424","Zilbrysq","1435","01/16/2024","7246","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_Patient_Guide.pdf" "424","Zilbrysq","1435","01/16/2024","7247","REMS Letter: Vaccination reminder to REMS certified prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_REMS_Letter_Vaccination_reminder_to_REMS_certified_prescribers.pdf" "424","Zilbrysq","1435","01/16/2024","7248","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Zilbrysq_2024_01_16_REMS_website.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7249","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_REMS_Website.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7250","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7251","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7252","XYWAV Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYWAV_Prescription_Form.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7253","XYREM Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYREM_Prescription_Form.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7254","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7255","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7256","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7257","XYWAV Brochure of Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYWAV_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7258","XYWAV Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYWAV_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7259","XYREM Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYREM_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7260","XYREM Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_XYREM_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7261","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7262","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7263","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7264","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_REMS_Document.pdf" "345","Xywav and Xyrem","1436","01/16/2024","7265","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2023_01_16_REMS_Full.pdf" "43","Prolia","1437","01/19/2024","7266","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_REMS_Website.pdf" "43","Prolia","1437","01/19/2024","7267","Journal Information Piece","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_Journal_Information_Piece.pdf" "43","Prolia","1437","01/19/2024","7268","Patient Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_Patient_Brochure.pdf" "43","Prolia","1437","01/19/2024","7269","Patient Counseling Chart","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_Patient_Counseling_Chart.pdf" "43","Prolia","1437","01/19/2024","7270","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_REMS_Letter_for_Healthcare_Providers.pdf" "43","Prolia","1437","01/19/2024","7271","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_REMS_Letter_for_Professional_Societies.pdf" "43","Prolia","1437","01/19/2024","7272","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_REMS_Full.pdf" "43","Prolia","1437","01/19/2024","7273","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_01_19_REMS_Document.pdf" "422","Hepzato","1438","01/22/2024","7274","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Website.pdf" "422","Hepzato","1438","01/22/2024","7275","Procedure Team Qualification Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Procedure_Team_Qualification_Status_Form.pdf" "422","Hepzato","1438","01/22/2024","7276","Severe Peri-Procedure-related Complications Adverse Events Documentation Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Severe_Peri-Procedure_related_Complications_Adverse_Events_Documentation_Form.pdf" "422","Hepzato","1438","01/22/2024","7277","Criteria for Procedural Competency Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Criteria_for_Procedural_Competency_Checklist.pdf" "422","Hepzato","1438","01/22/2024","7278","Didactic Modules","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Didactic_Modules.pdf" "422","Hepzato","1438","01/22/2024","7279","Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Healthcare_Setting_Enrollment_Form.pdf" "422","Hepzato","1438","01/22/2024","7280","Program Overview","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Program_Overview.pdf" "422","Hepzato","1438","01/22/2024","7281","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Document.pdf" "422","Hepzato","1438","01/22/2024","7282","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Full.pdf" "361","Sodium Oxybate","1439","01/17/2024","7283","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_REMS_Website.pdf" "361","Sodium Oxybate","1439","01/17/2024","7284","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Risk_Management_Report.pdf" "361","Sodium Oxybate","1439","01/17/2024","7285","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_REMS_Fact_Sheet.pdf" "361","Sodium Oxybate","1439","01/17/2024","7286","Dear Professional Society Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Dear_Professional_Society_Letter.pdf" "361","Sodium Oxybate","1439","01/17/2024","7287","Dear Healthcare Provider Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Dear_Healthcare_Provider_Letter.pdf" "361","Sodium Oxybate","1439","01/17/2024","7288","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Patient_Counseling_Checklist.pdf" "361","Sodium Oxybate","1439","01/17/2024","7289","Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Prescription_Form.pdf" "361","Sodium Oxybate","1439","01/17/2024","7290","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Module_B_Knowledge_Assessment.pdf" "361","Sodium Oxybate","1439","01/17/2024","7291","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Module_A_Knowledge_Assessment.pdf" "361","Sodium Oxybate","1439","01/17/2024","7292","Certified Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Certified_Pharmacy_Training.pdf" "361","Sodium Oxybate","1439","01/17/2024","7293","Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Patient_Quick_Start_Guide.pdf" "361","Sodium Oxybate","1439","01/17/2024","7294","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Prescriber_Brochure.pdf" "361","Sodium Oxybate","1439","01/17/2024","7295","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Pharmacy_Enrollment_Form.pdf" "361","Sodium Oxybate","1439","01/17/2024","7296","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Patient_Enrollment_Form.pdf" "361","Sodium Oxybate","1439","01/17/2024","7297","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_Prescriber_Enrollment_Form.pdf" "361","Sodium Oxybate","1439","01/17/2024","7298","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_REMS_Document.pdf" "361","Sodium Oxybate","1439","01/17/2024","7299","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2024_01_17_REMS_Full.pdf" "25","Juxtapid","1440","01/25/2024","7300","Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Fact_Sheet.pdf" "25","Juxtapid","1440","01/25/2024","7301","Prescriber Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Prescriber_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1440","01/25/2024","7302","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Pharmacy_Enrollment_Form.pdf" "25","Juxtapid","1440","01/25/2024","7303","Patient-Prescriber Acknolwedgement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Patient-Prescriber_Acknowledgement_Form.pdf" "25","Juxtapid","1440","01/25/2024","7304","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Patient_Guide.pdf" "25","Juxtapid","1440","01/25/2024","7305","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Prescriber_Enrollment_Form.pdf" "25","Juxtapid","1440","01/25/2024","7306","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_REMS_Document.pdf" "25","Juxtapid","1440","01/25/2024","7307","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Prescription_Authorization_Form.pdf" "25","Juxtapid","1440","01/25/2024","7308","Pharmacy Training Module and Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_Pharmacy_Training_Module_and_Knowledge_Assessment.pdf" "25","Juxtapid","1440","01/25/2024","7309","REMS Program Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Juxtapid_2024_01_25_REMS_Program_Website.pdf" "45","Qsymia","1441","02/06/2024","7310","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_REMS_Full.pdf" "45","Qsymia","1441","02/06/2024","7311","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_REMS-Document .pdf" "45","Qsymia","1441","02/06/2024","7312","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_Pharmacy_Enrollment_Form.pdf" "45","Qsymia","1441","02/06/2024","7313","Qsymia REMS Pharmacy Training","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_Qsymia_REMS_Pharmacy_Training.pdf" "45","Qsymia","1441","02/06/2024","7314","Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_Medication_Guide.pdf" "45","Qsymia","1441","02/06/2024","7315","Risk of Birth Defects with Qsymia","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_Risk_of_Birth_Defects_with_Qsymia.pdf" "45","Qsymia","1441","02/06/2024","7316","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2024_02_06_REMS_Website.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7317","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_REMS_Full.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7318","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_REMS_Website.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7319","REMS Fact Sheet","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_REMS_Fact_Sheet.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7320","Professional Society REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Professional_Society_REMS_Letter.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7321","Healthcare Provider REMS Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Healthcare_Provider_REMS_Letter.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7322","Pharmacy and Healthcare Setting Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Pharmacy_and_Healthcare_Setting_Training_Program.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7323","Patient Wallet Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Patient_Wallet_Card.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7324","Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Knowledge_Assessment.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7325","Adverse Reaction Medication Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Adverse_Reaction_Medication_Guide.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7326","Prescriber Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Prescriber_Training.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7327","Pharmacy and Healthcare Setting Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7328","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_Prescriber_Enrollment_Form.pdf" "415","Tecvayli and Talvey","1442","02/20/2024","7329","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_02_20_REMS_Document.pdf" "426","Jubbonti","1443","03/05/2024","7330","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_REMS_Full.pdf" "426","Jubbonti","1443","03/05/2024","7331","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_REMS_Document.pdf" "426","Jubbonti","1443","03/05/2024","7332","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_Patient_Guide.pdf" "426","Jubbonti","1443","03/05/2024","7333","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_REMS_Letter_for_Healthcare_Providers.pdf" "426","Jubbonti","1443","03/05/2024","7334","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_REMS_Letter_for_Professional_Societies.pdf" "426","Jubbonti","1443","03/05/2024","7335","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Jubbonti_2024_03_05_REMS_Website.pdf" "43","Prolia","1444","03/05/2024","7336","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_REMS_Full.pdf" "43","Prolia","1444","03/05/2024","7337","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_REMS_Document.pdf" "43","Prolia","1444","03/05/2024","7338","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_Patient_Guide.pdf" "43","Prolia","1444","03/05/2024","7339","REMS Letter for Healthcare Providers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_REMS_Letter_for_Healthcare_Providers.pdf" "43","Prolia","1444","03/05/2024","7340","REMS Letter for Professional Societies","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_REMS_Letter_for_Professional_Societies.pdf" "43","Prolia","1444","03/05/2024","7341","REMS Website Sreenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_03_05_REMS_website.pdf" "340","Lemtrada","1445","03/04/2024","7342","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_REMS_Full.pdf" "340","Lemtrada","1445","03/04/2024","7343","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_REMS_Document .pdf" "340","Lemtrada","1445","03/04/2024","7344","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Prescriber_Enrollment_Form.pdf" "340","Lemtrada","1445","03/04/2024","7345","Patient Enrollment and Prescription Ordering Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Enrollment_and_Prescription_Ordering_Form .pdf" "340","Lemtrada","1445","03/04/2024","7346","Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Pharmacy_Enrollment_Form.pdf" "340","Lemtrada","1445","03/04/2024","7347","Healthcare Facility Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Healthcare_Facility_Enrollment_Form.pdf" "340","Lemtrada","1445","03/04/2024","7348","REMS Education Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_REMS_Education_Program.pdf" "340","Lemtrada","1445","03/04/2024","7349","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Prescriber_Knowledge_Assessment.pdf" "340","Lemtrada","1445","03/04/2024","7350","Lemtrada Treatment and Infusion Reaction Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Lemtrada_Treatment_and_Infusion_Reaction_Patient_Guide .pdf" "340","Lemtrada","1445","03/04/2024","7351","Patient Safety Information Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Safety_Information_Card.pdf" "340","Lemtrada","1445","03/04/2024","7352","Patient Status Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Status_Form.pdf" "340","Lemtrada","1445","03/04/2024","7353","Patient Authorization and Baseline Lab Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Authorization_and_Baseline_Lab_Form .pdf" "340","Lemtrada","1445","03/04/2024","7354","Patient Transfer of Care Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Transfer_of_Care_Form.pdf" "340","Lemtrada","1445","03/04/2024","7355","Infusion Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Infusion_Checklist.pdf" "340","Lemtrada","1445","03/04/2024","7356","REMS Program Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_REMS_Program_Website.pdf" "340","Lemtrada","1445","03/04/2024","7357","Healthcare Provider Letter: Monitoring Reminder","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Healthcare_Provider_Letter_Monitoring_Reminder.pdf" "340","Lemtrada","1445","03/04/2024","7358","Patient Letter: Monitoring Reminder","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2024_03_04_Patient_Letter_Monitoring_Reminder.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7359","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_REMS_Website.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7360","Risk Management Report","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Risk_Management_Report.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7361","Patient Counseling Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Patient_Counseling_Checklist.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7362","Xywav Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYWAV_Prescription_Form.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7363","Xyrem Prescription Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYREM_Prescription_Form.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7364","Module B Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Module_B_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7365","Module A Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Module_A_Knowledge_Assessment.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7366","Certified Pharmacy Training Program","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Certified_Pharmacy_Training_Program.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7367","Xywav Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYWAV_Brochure_for_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7368","Xywav Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYWAV_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7369","Xyrem Brochure for Pediatric Patients and their Caregivers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYREM_Brochure_For_Pediatric_Patients_and_their_Caregivers.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7370","Xyrem Patient Quick Start Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_XYREM_Patient_Quick_Start_Guide.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7371","Prescriber Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Prescriber_Brochure.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7372","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Patient_Enrollment_Form.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7373","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_Prescriber_Enrollment_Form.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7374","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_REMS_Document.pdf" "345","Xywav and Xyrem","1446","03/04/2024","7375","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Xywav_and_Xyrem_2024_03_04_REMS_Full.pdf" "314","Myalept","1447","03/06/2024","7376","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_REMS_Website.pdf" "314","Myalept","1447","03/06/2024","7377","Prescription Authorization Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_Prescription_Authorization_Form.pdf" "314","Myalept","1447","03/06/2024","7378","REMS An Introduction","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_Myalpt_REMS_An_Introduction.pdf" "314","Myalept","1447","03/06/2024","7379","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_Prescriber_Enrollment_Form.pdf" "314","Myalept","1447","03/06/2024","7380","Prescriber Training Module","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_Prescriber_Training_Module.pdf" "314","Myalept","1447","03/06/2024","7381","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2024_03_06_REMS_Document.pdf" "427","Tryvio","1448","03/19/2024","7382","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_REMS_Website.pdf" "427","Tryvio","1448","03/19/2024","7383","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Patient_Guide.pdf" "427","Tryvio","1448","03/19/2024","7384","Risk of Birth Defects with TRYVIO","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Risk_of_Birth_Defects_with_TRYVIO.pdf" "427","Tryvio","1448","03/19/2024","7385","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Prescriber_and_Pharmacy_Guide.pdf" "427","Tryvio","1448","03/19/2024","7386","Prescriber Knowledge Assessment","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Prescriber_Knowledge_Assessment.pdf" "427","Tryvio","1448","03/19/2024","7387","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Inpatient_Pharmacy_Enrollment_Form.pdf" "427","Tryvio","1448","03/19/2024","7388","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Outpatient_Pharmacy_Enrollment_Form.pdf" "427","Tryvio","1448","03/19/2024","7389","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_Prescriber_Enrollment_Form.pdf" "427","Tryvio","1448","03/19/2024","7390","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_REMS_Document.pdf" "427","Tryvio","1448","03/19/2024","7391","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Tryvio_2024_03_19_REMS_Full.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7392","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_REMS_Website.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7393","Important Drug Safety Information for Pharmacists","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_Important_Drug_Safety_Information_for_Pharmacists.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7394","Dear Pharmacist Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_Dear_Pharmacist_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7395","Important Drug Safety Information for Prescribers","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_Important_Drug_Safety_Information_for_Prescribers.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7396","Dear Prescriber Letter","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_Dear_Prescriber_Letter.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7397","Appropriate Use Checklist","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_Appropriate_Use_Checklist.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7398","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_REMS_Document.pdf" "9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1449","03/20/2024","7399","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/BTOD_2024_03_20_REMS_Full.pdf" "405","Breyanzi","1450","03/14/2024","7400","Hospital Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2024_03_14_Hospital_Enrollment_Form.pdf" "405","Breyanzi","1450","03/14/2024","7401","REMS Website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2024_03_14_REMS_Website.pdf" "405","Breyanzi","1450","03/14/2024","7402","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2024_03_14_REMS_Document.pdf" "405","Breyanzi","1450","03/14/2024","7403","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Breyanzi_2024_03_14_REMS_Full.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7404","REMS website","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_REMS_Website.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7405","Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Change_in_Reproductive_Potential_Status_and_Pre-pubertal_Annual_Verification_Form.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7406","Guide for Female Patients","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Guide_for_Female_Patients.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7407","Prescriber and Pharmacy Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Prescriber_and_Pharmacy_Guide.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7408","Inpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Inpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7409","Outpatient Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Outpatient_Pharmacy_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7410","Patient Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Patient_Enrollment_Form.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7411","Prescriber Enrollment and Agreement Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_Prescriber_Enrollment_and_Agreement_Form.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7412","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_REMS_Document.pdf" "407","Macitentan-Containing Products","1451","03/22/2024","7413","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Macitentan-Containing_Products_2024_03_22_REMS_Full.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7414","REMS Full","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_REMS_Full.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7415","REMS Document","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_REMS_Document.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7416","Prescriber Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_Prescriber_Enrollment_Form .pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7417","Healthcare Setting and Pharmacy Enrollment Form","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7418","Healthcare Provider Safety Brochure","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_Healthcare_Provider_Safety_Brochure.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7419","Patient Safety Card","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_Patient_Safety_Card.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7420","Patient Guide","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_Patient_Guide.pdf" "429","Ultomiris and Soliris","1454","03/22/2024","7421","REMS Website Screenshots","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_and_Soliris_2024__03_22_REMS_Website_Screenshots.pdf"