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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 2016

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on June 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2016 HICON
NDA #021305		 SUPPL-39 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
04/01/2016 SODIUM IODIDE I 131
NDA #021305		 SUPPL-39 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
04/01/2016 TINDAMAX
NDA #021618		 SUPPL-5 TINIDAZOLE MISSION PHARMA Manufacturing (CMC) Approval
04/01/2016 ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
ANDA #078709		 ORIG-1 GLIMEPIRIDE; ROSIGLITAZONE MALEATE TEVA PHARMS USA Approval
04/01/2016 JUBLIA
NDA #203567		 SUPPL-5 EFINACONAZOLE BAUSCH Manufacturing (CMC) Approval
04/01/2016 TRIUMEQ
NDA #205551		 SUPPL-6 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Manufacturing (CMC) Approval
04/04/2016 ZYRTEC ALLERGY
NDA #019835		 SUPPL-36 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/04/2016 ZYRTEC HIVES RELIEF
NDA #019835		 SUPPL-36 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/04/2016 HABITROL
NDA #020076		 SUPPL-39 NICOTINE DR REDDYS LABS SA Manufacturing (CMC) Approval
04/04/2016 VAGIFEM
NDA #020908		 SUPPL-23 ESTRADIOL NOVO NORDISK INC Manufacturing (CMC) Approval
04/04/2016 ACIPHEX
NDA #020973		 SUPPL-33 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
04/04/2016 OXACILLIN SODIUM
ANDA #062984		 SUPPL-17 OXACILLIN SODIUM WATSON LABS INC Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077021		 SUPPL-13 CILOSTAZOL CASI PHARMS INC Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077027		 SUPPL-16 CILOSTAZOL TEVA Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077027		 SUPPL-17 CILOSTAZOL TEVA Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077030		 SUPPL-5 CILOSTAZOL APOTEX INC Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077030		 SUPPL-6 CILOSTAZOL APOTEX INC Labeling Approval
04/04/2016 CILOSTAZOL
ANDA #077310		 SUPPL-11 CILOSTAZOL CASI PHARMS INC Labeling Approval
04/04/2016 CARVEDILOL
ANDA #077316		 SUPPL-14 CARVEDILOL MYLAN Labeling Approval
04/04/2016 CARVEDILOL
ANDA #078332		 SUPPL-21 CARVEDILOL AUROBINDO PHARMA Labeling Approval
04/04/2016 OXACILLIN SODIUM
ANDA #091246		 SUPPL-1 OXACILLIN SODIUM SAGENT PHARMS Labeling Approval
04/04/2016 PANTOPRAZOLE SODIUM
ANDA #202038		 SUPPL-9 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
04/04/2016 CAPECITABINE
ANDA #202593		 SUPPL-1 CAPECITABINE ACCORD HLTHCARE Manufacturing (CMC) Approval
04/04/2016 BOSULIF
NDA #203341		 SUPPL-5 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
04/04/2016 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-3 RABEPRAZOLE SODIUM AYTU Labeling Approval
04/04/2016 VARUBI
NDA #206500		 SUPPL-1 ROLAPITANT HYDROCHLORIDE TERSERA Manufacturing (CMC) Approval
04/04/2016 POLYMYXIN B SULFATE
ANDA #206589		 ORIG-1 POLYMYXIN B SULFATE EUGIA PHARMA Approval
04/04/2016 DESCOVY
NDA #208215		 ORIG-1 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Type 4 - New Combination Approval
04/05/2016 HUMULIN N
BLA #018781		 SUPPL-163 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/05/2016 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-66 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-69 HEPARIN SODIUM HOSPIRA Labeling Approval
04/05/2016 IMODIUM A-D
NDA #019487		 SUPPL-28 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
04/05/2016 INOMAX
NDA #020845		 SUPPL-18 NITRIC OXIDE MALLINCKRODT HOSP Labeling Approval
04/05/2016 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-21 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
04/05/2016 CLARITIN
NDA #021891		 SUPPL-21 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
04/05/2016 NESINA
NDA #022271		 SUPPL-5 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Efficacy Approval
04/05/2016 ONGLYZA
NDA #022350		 SUPPL-14 SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
04/05/2016 OSENI
NDA #022426		 SUPPL-3 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
04/05/2016 EXPAREL
NDA #022496		 SUPPL-17 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
04/05/2016 METFORMIN HYDROCHLORIDE
ANDA #090564		 SUPPL-5 METFORMIN HYDROCHLORIDE GRANULES INDIA Manufacturing (CMC) Approval
04/05/2016 CAMPATH
BLA #103948		 SUPPL-5153 ALEMTUZUMAB GENZYME Approval
04/05/2016 LEMTRADA
BLA #103948		 SUPPL-5153 ALEMTUZUMAB GENZYME Approval
04/05/2016 INFLECTRA
BLA #125544		 ORIG-1 INFLIXIMAB-DYYB CELLTRION INC Approval
04/05/2016 KOMBIGLYZE XR
NDA #200678		 SUPPL-13 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
04/05/2016 KAZANO
NDA #203414		 SUPPL-3 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
04/05/2016 LONSURF
NDA #207981		 SUPPL-3 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Manufacturing (CMC) Approval
04/06/2016 LOPID
NDA #018422		 SUPPL-55 GEMFIBROZIL PFIZER PHARMS Labeling Approval
04/06/2016 ZONEGRAN
NDA #020789		 SUPPL-34 ZONISAMIDE CONCORDIA Labeling Approval
04/06/2016 KEPPRA
NDA #021872		 SUPPL-21 LEVETIRACETAM UCB INC Labeling Approval
04/06/2016 KEPPRA XR
NDA #022285		 SUPPL-22 LEVETIRACETAM UCB INC Labeling Approval
04/06/2016 LINZESS
NDA #202811		 SUPPL-7 LINACLOTIDE ABBVIE Labeling Approval
04/06/2016 ORKAMBI
NDA #206038		 SUPPL-3 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Manufacturing (CMC) Approval
04/07/2016 VALSTAR PRESERVATIVE FREE
NDA #020892		 SUPPL-19 VALRUBICIN ENDO OPERATIONS Labeling Approval
04/07/2016 LOPROX
NDA #021159		 SUPPL-22 CICLOPIROX BAUSCH Manufacturing (CMC) Approval
04/07/2016 STARLIX
NDA #021204		 SUPPL-19 NATEGLINIDE NOVARTIS Manufacturing (CMC) Approval
04/07/2016 XANAX XR
NDA #021434		 SUPPL-15 ALPRAZOLAM UPJOHN Manufacturing (CMC) Approval
04/07/2016 ENDOMETRIN
NDA #022057		 SUPPL-8 PROGESTERONE FERRING Manufacturing (CMC) Approval
04/07/2016 NICARDIPINE HYDROCHLORIDE
NDA #022276		 SUPPL-8 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
04/07/2016 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276		 SUPPL-8 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
04/07/2016 AFREZZA
BLA #022472		 SUPPL-10 INSULIN RECOMBINANT HUMAN MANNKIND Approval
04/07/2016 LISINOPRIL
ANDA #077622		 SUPPL-22 LISINOPRIL AUROBINDO Labeling Approval
04/07/2016 LEVETIRACETAM
ANDA #091557		 SUPPL-7 LEVETIRACETAM ACTAVIS ELIZABETH Labeling Approval
04/07/2016 LEVETIRACETAM
ANDA #091557		 SUPPL-8 LEVETIRACETAM ACTAVIS ELIZABETH Labeling Approval
04/07/2016 GEMCITABINE HYDROCHLORIDE
NDA #200795		 SUPPL-6 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
04/07/2016 VIZAMYL
NDA #203137		 SUPPL-5 FLUTEMETAMOL F-18 GE HEALTHCARE Labeling Approval
04/07/2016 ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #205703		 ORIG-1 ESMOLOL HYDROCHLORIDE HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
04/07/2016 ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #205703		 ORIG-1 ESMOLOL HYDROCHLORIDE HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
04/08/2016 VERAPAMIL HYDROCHLORIDE
NDA #018925		 SUPPL-9 VERAPAMIL HYDROCHLORIDE EXELA PHARMA Manufacturing (CMC) Approval
04/08/2016 CERETEC
NDA #019829		 SUPPL-28 TECHNETIUM TC-99M EXAMETAZIME KIT GE HEALTHCARE Manufacturing (CMC) Approval
04/08/2016 RILUTEK
NDA #020599		 SUPPL-17 RILUZOLE COVIS Labeling Approval
04/08/2016 ORAPRED ODT
NDA #021959		 SUPPL-8 PREDNISOLONE SODIUM PHOSPHATE CONCORDIA PHARMS INC Manufacturing (CMC) Approval
04/08/2016 ADDYI
NDA #022526		 SUPPL-2 FLIBANSERIN SPROUT PHARMS REMS Approval
04/08/2016 AMPICILLIN AND SULBACTAM
ANDA #065316		 SUPPL-8 AMPICILLIN SODIUM; SULBACTAM SODIUM PHARM ASSOC Labeling Approval
04/08/2016 AMPICILLIN AND SULBACTAM
ANDA #065316		 SUPPL-9 AMPICILLIN SODIUM; SULBACTAM SODIUM PHARM ASSOC Labeling Approval
04/08/2016 ACYCLOVIR
ANDA #075090		 SUPPL-11 ACYCLOVIR INDOCO Labeling Approval
04/08/2016 ESMOLOL HYDROCHLORIDE
ANDA #076573		 SUPPL-5 ESMOLOL HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
04/08/2016 ALENDRONATE SODIUM
ANDA #076584		 SUPPL-15 ALENDRONATE SODIUM RISING Labeling Approval
04/08/2016 ALENDRONATE SODIUM
ANDA #090022		 SUPPL-12 ALENDRONATE SODIUM SUN PHARM Labeling Approval
04/08/2016 ALENDRONATE SODIUM
ANDA #090124		 SUPPL-14 ALENDRONATE SODIUM AUROBINDO PHARMA Labeling Approval
04/08/2016 ADENOSINE
ANDA #090212		 SUPPL-5 ADENOSINE MYLAN ASI Labeling Approval
04/08/2016 NICOTINE POLACRILEX
ANDA #091354		 SUPPL-8 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
04/08/2016 VALCHLOR
NDA #202317		 SUPPL-5 MECHLORETHAMINE HYDROCHLORIDE HELSINN Manufacturing (CMC) Approval
04/08/2016 SKYLA
NDA #203159		 SUPPL-5 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
04/08/2016 PROVAYBLUE
NDA #204630		 ORIG-1 METHYLENE BLUE PROVEPHARM SAS Type 5 - New Formulation or New Manufacturer Approval
04/08/2016 BUDESONIDE
ANDA #206623		 ORIG-1 BUDESONIDE DR REDDYS LABS SA Approval
04/08/2016 BROMSITE
NDA #206911		 ORIG-1 BROMFENAC SODIUM SUN PHARM Type 5 - New Formulation or New Manufacturer Approval
04/08/2016 RALOXIFENE HYDROCHLORIDE
ANDA #208206		 ORIG-1 RALOXIFENE HYDROCHLORIDE AMNEAL PHARMS Approval
04/11/2016 ALDACTONE
NDA #012151		 SUPPL-74 SPIRONOLACTONE PFIZER Manufacturing (CMC) Approval
04/11/2016 EXIDINE
NDA #019422		 SUPPL-46 CHLORHEXIDINE GLUCONATE XTTRIUM Manufacturing (CMC) Approval
04/11/2016 PRECEDEX
NDA #021038		 SUPPL-27 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Labeling Approval
04/11/2016 ARIXTRA
NDA #021345		 SUPPL-33 FONDAPARINUX SODIUM MYLAN IRELAND LTD Manufacturing (CMC) Approval
04/11/2016 PREZISTA
NDA #021976		 SUPPL-42 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
04/11/2016 NOXAFIL
NDA #022003		 SUPPL-19 POSACONAZOLE SCHERING Manufacturing (CMC) Approval
04/11/2016 DUREZOL
NDA #022212		 SUPPL-15 DIFLUPREDNATE SANDOZ Manufacturing (CMC) Approval
04/11/2016 OXACILLIN SODIUM
ANDA #061490		 SUPPL-32 OXACILLIN SODIUM SANDOZ Labeling Approval
04/11/2016 OXACILLIN SODIUM
ANDA #061490		 SUPPL-37 OXACILLIN SODIUM SANDOZ Manufacturing (CMC) Approval
04/11/2016 OXACILLIN SODIUM
ANDA #061490		 SUPPL-39 OXACILLIN SODIUM SANDOZ Labeling Approval
04/11/2016 KRYSTEXXA
BLA #125293		 SUPPL-86 PEGLOTICASE HORIZON PHARMA Approval
04/11/2016 KABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-2 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Manufacturing (CMC) Approval
04/11/2016 PERIKABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-2 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Manufacturing (CMC) Approval
04/11/2016 FLUDEOXYGLUCOSE F18
ANDA #203942		 ORIG-1 FLUDEOXYGLUCOSE F-18 KREITCHMAN PET CTR Approval
04/11/2016 ROPIVACAINE HYDROCHLORIDE
ANDA #203955		 ORIG-1 ROPIVACAINE HYDROCHLORIDE RISING Approval
04/11/2016 GEMCITABINE HYDROCHLORIDE
ANDA #204549		 ORIG-1 GEMCITABINE HYDROCHLORIDE ACTAVIS INC Approval
04/11/2016 HETLIOZ
NDA #205677		 SUPPL-2 TASIMELTEON VANDA PHARMS INC Manufacturing (CMC) Approval
04/11/2016 VENCLEXTA
NDA #208573		 ORIG-1 VENETOCLAX ABBVIE Type 1 - New Molecular Entity Approval
04/12/2016 PHOSLO
NDA #021160		 SUPPL-29 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/12/2016 PHOSLO GELCAPS
NDA #021160		 SUPPL-29 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/12/2016 CANCIDAS
NDA #021227		 SUPPL-34 CASPOFUNGIN ACETATE MERCK Labeling Approval
04/12/2016 CANCIDAS
NDA #021227		 SUPPL-35 CASPOFUNGIN ACETATE MERCK Labeling Approval
04/12/2016 WARFARIN SODIUM
ANDA #040663		 SUPPL-11 WARFARIN SODIUM ZYDUS PHARMS USA Labeling Approval
04/12/2016 CEFUROXIME SODIUM
ANDA #064125		 SUPPL-9 CEFUROXIME SODIUM ACS DOBFAR SPA Labeling Approval
04/12/2016 CEFUROXIME
ANDA #065048		 SUPPL-14 CEFUROXIME HIKMA Labeling Approval
04/12/2016 CEFUROXIME SODIUM
ANDA #065048		 SUPPL-14 CEFUROXIME SODIUM HIKMA Labeling Approval
04/12/2016 CEFUROXIME SODIUM
ANDA #065483		 SUPPL-2 CEFUROXIME SODIUM HOSPIRA INC Labeling Approval
04/12/2016 NIFEDIPINE
ANDA #072556		 SUPPL-37 NIFEDIPINE ACTAVIS ELIZABETH Labeling Approval
04/12/2016 NIFEDIPINE
ANDA #072579		 SUPPL-36 NIFEDIPINE ACTAVIS ELIZABETH Labeling Approval
04/12/2016 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-13 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
04/12/2016 ENALAPRIL MALEATE
ANDA #075556		 SUPPL-5 ENALAPRIL MALEATE SUN PHARM INDS LTD Labeling Approval
04/12/2016 ENALAPRIL MALEATE
ANDA #075556		 SUPPL-6 ENALAPRIL MALEATE SUN PHARM INDS LTD Labeling Approval
04/12/2016 MORPHINE SULFATE
ANDA #200411		 ORIG-1 MORPHINE SULFATE IMPAX LABS INC Approval
04/12/2016 KABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-1 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Labeling Approval
04/12/2016 PERIKABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-1 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Labeling Approval
04/12/2016 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202991		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE RHODES PHARMS Approval
04/12/2016 DONEPEZIL HYDROCHLORIDE
ANDA #203419		 ORIG-1 DONEPEZIL HYDROCHLORIDE CHARTWELL RX Approval
04/12/2016 AKYNZEO
NDA #205718		 SUPPL-6 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Manufacturing (CMC) Approval
04/12/2016 MEROPENEM
ANDA #205883		 ORIG-1 MEROPENEM AMNEAL PHARMS Approval
04/12/2016 TEMOZOLOMIDE
ANDA #206413		 ORIG-1 TEMOZOLOMIDE CHARTWELL Approval
04/12/2016 OXYCODONE HYDROCHLORIDE
ANDA #207119		 ORIG-1 OXYCODONE HYDROCHLORIDE NUVO PHARM Approval
04/13/2016 LANTUS
BLA #021081		 SUPPL-65 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
04/13/2016 LANTUS SOLOSTAR
BLA #021081		 SUPPL-65 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
04/13/2016 SPRINTEC
ANDA #075804		 SUPPL-26 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
04/13/2016 SPRINTEC
ANDA #075804		 SUPPL-27 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
04/13/2016 TRI-SPRINTEC
ANDA #075808		 SUPPL-30 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
04/13/2016 TRI-SPRINTEC
ANDA #075808		 SUPPL-31 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
04/13/2016 MINOCYCLINE HYDROCHLORIDE
ANDA #091424		 SUPPL-1 MINOCYCLINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/13/2016 SOLIRIS
BLA #125166		 SUPPL-414 ECULIZUMAB ALEXION PHARM Approval
04/13/2016 RYTARY
NDA #203312		 SUPPL-3 CARBIDOPA; LEVODOPA IMPAX Manufacturing (CMC) Approval
04/13/2016 VORICONAZOLE
ANDA #205034		 ORIG-1 VORICONAZOLE AMNEAL PHARMS Approval
04/13/2016 FLURANDRENOLIDE
ANDA #205342		 ORIG-1 FLURANDRENOLIDE CHARTWELL RX Approval
04/13/2016 IMBRUVICA
NDA #205552		 SUPPL-11 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
04/13/2016 DAKLINZA
NDA #206843		 SUPPL-4 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Manufacturing (CMC) Approval
04/14/2016 VIRAMUNE
NDA #020636		 SUPPL-47 NEVIRAPINE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/14/2016 RECLAST
NDA #021817		 SUPPL-22 ZOLEDRONIC ACID SANDOZ Labeling Approval
04/14/2016 CHILDREN'S ZYRTEC ALLERGY
NDA #022155		 SUPPL-10 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/14/2016 CHILDREN'S ZYRTEC HIVES RELIEF
NDA #022155		 SUPPL-10 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/14/2016 XERESE
NDA #022436		 SUPPL-6 ACYCLOVIR; HYDROCORTISONE BAUSCH Manufacturing (CMC) Approval
04/14/2016 OXYCODONE AND ACETAMINOPHEN
ANDA #090177		 SUPPL-4 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Manufacturing (CMC) Approval
04/14/2016 ZYFREL
ANDA #090468		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE CYPRESS PHARM INC Approval
04/14/2016 GLYBURIDE
ANDA #203581		 ORIG-1 GLYBURIDE CHARTWELL RX Approval
04/14/2016 INVOKAMET
NDA #204353		 SUPPL-11 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Manufacturing (CMC) Approval
04/14/2016 POLYMYXIN B SULFATE
ANDA #207322		 ORIG-1 POLYMYXIN B SULFATE GLAND Approval
04/15/2016 OPTISON
NDA #020899		 SUPPL-17 ALBUMIN HUMAN GE HEALTHCARE Manufacturing (CMC) Approval
04/15/2016 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-11 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/15/2016 CLOBEX
NDA #021835		 SUPPL-10 CLOBETASOL PROPIONATE GALDERMA LABS LP Manufacturing (CMC) Approval
04/15/2016 VYVANSE
NDA #021977		 SUPPL-20 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
04/15/2016 SUBOXONE
NDA #022410		 SUPPL-24 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
04/15/2016 EXPAREL
NDA #022496		 SUPPL-18 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
04/15/2016 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #200243		 SUPPL-10 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LANNETT CO INC Labeling Approval
04/15/2016 GILOTRIF
NDA #201292		 SUPPL-7 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Efficacy Approval
04/15/2016 PICATO
NDA #202833		 SUPPL-6 INGENOL MEBUTATE LEO LABS Manufacturing (CMC) Approval
04/15/2016 TYBOST
NDA #203094		 SUPPL-4 COBICISTAT GILEAD SCIENCES INC Manufacturing (CMC) Approval
04/15/2016 PHOTREXA
NDA #203324		 ORIG-1 RIBOFLAVIN 5'-PHOSPHATE GLAUKOS Type 3 - New Dosage Form Approval
04/15/2016 PHOTREXA VISCOUS IN DEXTRAN 20%
NDA #203324		 ORIG-1 RIBOFLAVIN 5'-PHOSPHATE GLAUKOS Type 3 - New Dosage Form Approval
04/15/2016 FOSAMPRENAVIR CALCIUM
ANDA #204060		 ORIG-1 FOSAMPRENAVIR CALCIUM MYLAN Approval
04/15/2016 SODIUM PHENYLBUTYRATE
ANDA #204395		 ORIG-1 SODIUM PHENYLBUTYRATE ENDO OPERATIONS Approval
04/15/2016 JARDIANCE
NDA #204629		 SUPPL-11 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/15/2016 DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
ANDA #206304		 ORIG-1 DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE COREPHARMA Tentative Approval
04/15/2016 TRIMIPRAMINE MALEATE
ANDA #208127		 ORIG-1 TRIMIPRAMINE MALEATE BRECKENRIDGE Approval
04/18/2016 BACTRIM
NDA #017377		 SUPPL-78 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/18/2016 BACTRIM DS
NDA #017377		 SUPPL-78 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/18/2016 ATIVAN
NDA #018140		 SUPPL-38 LORAZEPAM HIKMA Manufacturing (CMC) Approval
04/18/2016 ZOVIRAX
NDA #019909		 SUPPL-23 ACYCLOVIR MYLAN Manufacturing (CMC) Approval
04/18/2016 VERAPAMIL HYDROCHLORIDE
ANDA #071881		 SUPPL-11 VERAPAMIL HYDROCHLORIDE HERITAGE PHARMS Labeling Approval
04/18/2016 ENALAPRIL MALEATE
ANDA #075480		 SUPPL-14 ENALAPRIL MALEATE AUROBINDO PHARMA USA Labeling Approval
04/18/2016 ENALAPRIL MALEATE
ANDA #075480		 SUPPL-15 ENALAPRIL MALEATE AUROBINDO PHARMA USA Labeling Approval
04/18/2016 GLIPIZIDE
ANDA #202298		 SUPPL-3 GLIPIZIDE MYLAN Labeling Approval
04/18/2016 VARITHENA
NDA #205098		 SUPPL-16 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
04/19/2016 ACTHAR GEL
NDA #008372		 SUPPL-51 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
04/19/2016 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-51 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
04/19/2016 LOESTRIN 24 FE
NDA #021871		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
04/19/2016 NESINA
NDA #022271		 SUPPL-8 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
04/19/2016 GRIS-PEG
NDA #050475		 SUPPL-57 GRISEOFULVIN, ULTRAMICROSIZE BAUSCH Labeling Approval
04/19/2016 CIPROFLOXACIN
ANDA #076089		 SUPPL-45 CIPROFLOXACIN IVAX SUB TEVA PHARMS Labeling Approval
04/19/2016 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076089		 SUPPL-45 CIPROFLOXACIN HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
04/19/2016 TRI LO SPRINTEC
ANDA #076784		 SUPPL-7 ETHINYL ESTRADIOL; NORGESTIMATE BARR LABS INC Labeling Approval
04/19/2016 BICALUTAMIDE
ANDA #076932		 SUPPL-5 BICALUTAMIDE TEVA Labeling Approval
04/19/2016 GALANTAMINE HYDROBROMIDE
ANDA #078898		 SUPPL-6 GALANTAMINE HYDROBROMIDE ZYDUS PHARMS USA INC Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088131		 SUPPL-46 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088132		 SUPPL-45 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088133		 SUPPL-46 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088134		 SUPPL-46 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088135		 SUPPL-34 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088136		 SUPPL-19 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/19/2016 GALANTAMINE HYDROBROMIDE
ANDA #090178		 SUPPL-7 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
04/19/2016 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
ANDA #090747		 SUPPL-4 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE AM REGENT Labeling Approval
04/19/2016 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
ANDA #090747		 SUPPL-5 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE AM REGENT Labeling Approval
04/19/2016 MINOCYCLINE HYDROCHLORIDE
ANDA #090911		 SUPPL-3 MINOCYCLINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
04/19/2016 GALANTAMINE HYDROBROMIDE
ANDA #090957		 SUPPL-10 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA LTD Labeling Approval
04/19/2016 BETASERON
BLA #103471		 SUPPL-5157 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
04/19/2016 BETASERON
BLA #103471		 SUPPL-5187 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
04/19/2016 NPLATE
BLA #125268		 SUPPL-155 ROMIPLOSTIM AMGEN Approval
04/19/2016 NPLATE
BLA #125268		 SUPPL-156 ROMIPLOSTIM AMGEN Approval
04/19/2016 BIMATOPROST
ANDA #202719		 ORIG-1 BIMATOPROST SANDOZ Approval
04/19/2016 INDOMETHACIN SODIUM
ANDA #204118		 ORIG-1 INDOMETHACIN SODIUM HOSPIRA Approval
04/19/2016 MONTELUKAST SODIUM
ANDA #204290		 SUPPL-1 MONTELUKAST SODIUM UNICHEM Labeling Approval
04/19/2016 MONTELUKAST SODIUM
ANDA #204290		 SUPPL-2 MONTELUKAST SODIUM UNICHEM Labeling Approval
04/19/2016 MEROPENEM
ANDA #206086		 ORIG-1 MEROPENEM SAVIOR LIFETEC CORP Approval
04/20/2016 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-39 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/20/2016 MS CONTIN
NDA #019516		 SUPPL-47 MORPHINE SULFATE PURDUE PHARMA LP REMS Approval
04/20/2016 DURAGESIC-100
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 DURAGESIC-12
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 DURAGESIC-25
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 DURAGESIC-37
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 DURAGESIC-50
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 DURAGESIC-75
NDA #019813		 SUPPL-67 FENTANYL JANSSEN PHARMS REMS Approval
04/20/2016 KADIAN
NDA #020616		 SUPPL-55 MORPHINE SULFATE ALLERGAN REMS Approval
04/20/2016 EXALGO
NDA #021217		 SUPPL-17 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/20/2016 BUTRANS
NDA #021306		 SUPPL-23 BUPRENORPHINE PURDUE PHARMA LP REMS Approval
04/20/2016 OPANA ER
NDA #021610		 SUPPL-21 OXYMORPHONE HYDROCHLORIDE ENDO OPERATIONS REMS Approval
04/20/2016 OXALIPLATIN
NDA #022160		 SUPPL-10 OXALIPLATIN TEVA PHARMS Labeling Approval
04/20/2016 OXYCONTIN
NDA #022272		 SUPPL-33 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
04/20/2016 EMBEDA
NDA #022321		 SUPPL-21 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS REMS Approval
04/20/2016 METHADOSE
ANDA #040050		 SUPPL-21 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-14 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-18 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #074769		 SUPPL-24 MORPHINE SULFATE RHODES PHARMS REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #074862		 SUPPL-23 MORPHINE SULFATE RHODES PHARMS REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #075295		 SUPPL-44 MORPHINE SULFATE STRIDES PHARMA REMS Approval
04/20/2016 FENTANYL-100
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-12
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-25
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-37
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-50
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-62
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-75
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 FENTANYL-87
ANDA #076258		 SUPPL-32 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #076412		 SUPPL-22 MORPHINE SULFATE SPECGX LLC REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #076438		 SUPPL-19 MORPHINE SULFATE SPECGX LLC REMS Approval
04/20/2016 FENTANYL-100
ANDA #076709		 SUPPL-26 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/20/2016 FENTANYL-25
ANDA #076709		 SUPPL-26 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/20/2016 FENTANYL-50
ANDA #076709		 SUPPL-26 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/20/2016 FENTANYL-75
ANDA #076709		 SUPPL-26 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #076720		 SUPPL-19 MORPHINE SULFATE NESHER PHARMS REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #076733		 SUPPL-18 MORPHINE SULFATE NESHER PHARMS REMS Approval
04/20/2016 FENTANYL-100
ANDA #077062		 SUPPL-29 FENTANYL MAYNE PHARMA REMS Approval
04/20/2016 FENTANYL-25
ANDA #077062		 SUPPL-29 FENTANYL MAYNE PHARMA REMS Approval
04/20/2016 FENTANYL-50
ANDA #077062		 SUPPL-29 FENTANYL MAYNE PHARMA REMS Approval
04/20/2016 FENTANYL-75
ANDA #077062		 SUPPL-29 FENTANYL MAYNE PHARMA REMS Approval
04/20/2016 FENTANYL-100
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-12
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-25
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-37
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-50
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-62
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-75
ANDA #077154		 SUPPL-12 FENTANYL SPECGX LLC REMS Approval
04/20/2016 FENTANYL-100
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-12
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-25
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-37
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-50
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-62
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-75
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-87
ANDA #077449		 SUPPL-18 FENTANYL AVEVA REMS Approval
04/20/2016 FENTANYL-100
ANDA #077775		 SUPPL-20 FENTANYL NOVEN REMS Approval
04/20/2016 FENTANYL-25
ANDA #077775		 SUPPL-20 FENTANYL NOVEN REMS Approval
04/20/2016 FENTANYL-50
ANDA #077775		 SUPPL-20 FENTANYL NOVEN REMS Approval
04/20/2016 FENTANYL-75
ANDA #077775		 SUPPL-20 FENTANYL NOVEN REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #077855		 SUPPL-16 MORPHINE SULFATE NESHER PHARMS REMS Approval
04/20/2016 MELOXICAM
ANDA #077921		 SUPPL-14 MELOXICAM ZYDUS PHARMS USA Manufacturing (CMC) Approval
04/20/2016 MORPHINE SULFATE
ANDA #078761		 SUPPL-8 MORPHINE SULFATE SUN PHARM INDS LTD REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #079040		 SUPPL-11 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-23 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-20 OXYMORPHONE HYDROCHLORIDE IMPAX LABS REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-38 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-29 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-34 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #090065		 SUPPL-1 METHADONE HYDROCHLORIDE EPIC PHARMA LLC REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-13 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-7 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
04/20/2016 LIOTHYRONINE SODIUM
ANDA #091382		 ORIG-1 LIOTHYRONINE SODIUM SUN PHARM Approval
04/20/2016 MORPHINE SULFATE
ANDA #200411		 SUPPL-1 MORPHINE SULFATE IMPAX LABS INC REMS Approval
04/20/2016 NUCYNTA ER
NDA #200533		 SUPPL-13 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #200792		 SUPPL-2 OXYMORPHONE HYDROCHLORIDE PAR PHARM REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #200812		 SUPPL-8 MORPHINE SULFATE STRIDES PHARMA REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 SUPPL-6 OXYMORPHONE HYDROCHLORIDE HIKMA REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #200824		 SUPPL-13 MORPHINE SULFATE RISING REMS Approval
04/20/2016 GILOTRIF
NDA #201292		 SUPPL-9 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Labeling Approval
04/20/2016 OPANA ER
NDA #201655		 SUPPL-20 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #202104		 SUPPL-6 MORPHINE SULFATE UPSHER SMITH LABS REMS Approval
04/20/2016 HYDROMORPHONE HYDROCHLORIDE
ANDA #202144		 SUPPL-8 HYDROMORPHONE HYDROCHLORIDE ACTAVIS LABS FL INC REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #202718		 SUPPL-3 MORPHINE SULFATE TEVA PHARMS USA REMS Approval
04/20/2016 ZOHYDRO ER
NDA #202880		 SUPPL-7 HYDROCODONE BITARTRATE RECRO GAINESVILLE REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #202946		 SUPPL-3 OXYMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/20/2016 METHADONE HYDROCHLORIDE
ANDA #203502		 SUPPL-1 METHADONE HYDROCHLORIDE AUROLIFE PHARMA LLC REMS Approval
04/20/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #203506		 SUPPL-2 OXYMORPHONE HYDROCHLORIDE SUN PHARM INDS LTD REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #203602		 SUPPL-1 MORPHINE SULFATE NOVEL LABS INC REMS Approval
04/20/2016 MORPHINE SULFATE
ANDA #203849		 SUPPL-4 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
04/20/2016 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 SUPPL-3 HYDROMORPHONE HYDROCHLORIDE PADAGIS US REMS Approval
04/20/2016 TARGINIQ
NDA #205777		 SUPPL-3 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
04/20/2016 MORPHABOND ER
NDA #206544		 SUPPL-1 MORPHINE SULFATE OHEMO LIFE REMS Approval
04/20/2016 HYSINGLA ER
NDA #206627		 SUPPL-3 HYDROCODONE BITARTRATE PURDUE PHARMA LP REMS Approval
04/20/2016 BELBUCA
NDA #207932		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE BDSI REMS Approval
04/21/2016 INTRALIPID 10%
NDA #017643		 SUPPL-75 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
04/21/2016 NITROLINGUAL
NDA #018705		 SUPPL-20 NITROGLYCERIN POHL BOSKAMP Manufacturing (CMC) Approval
04/21/2016 NITROLINGUAL PUMPSPRAY
NDA #018705		 SUPPL-20 NITROGLYCERIN POHL BOSKAMP Manufacturing (CMC) Approval
04/21/2016 SAIZEN
BLA #019764		 SUPPL-80 SOMATROPIN EMD SERONO Approval
04/21/2016 ZESTRIL
NDA #019777		 SUPPL-74 LISINOPRIL TWI PHARMS Labeling Approval
04/21/2016 CEREZYME
BLA #020367		 SUPPL-97 IMIGLUCERASE GENZYME Approval
04/21/2016 VAGISTAT-1
NDA #020676		 SUPPL-11 TIOCONAZOLE COMBE Manufacturing (CMC) Approval
04/21/2016 OLUX E
NDA #022013		 SUPPL-11 CLOBETASOL PROPIONATE MYLAN Manufacturing (CMC) Approval
04/21/2016 ZEGERID OTC
NDA #022281		 SUPPL-10 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Manufacturing (CMC) Approval
04/21/2016 PALONOSETRON HYDROCHLORIDE
ANDA #201533		 ORIG-1 PALONOSETRON HYDROCHLORIDE DR REDDYS Approval
04/21/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Approval
04/21/2016 TRIUMEQ
NDA #205551		 SUPPL-5 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
04/21/2016 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 ORIG-1 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Approval
04/21/2016 FLOLIPID
NDA #206679		 ORIG-1 SIMVASTATIN SALERNO PHARMS Type 3 - New Dosage Form Approval
04/22/2016 TRIAMCINOLONE ACETONIDE
NDA #011601		 SUPPL-43 TRIAMCINOLONE ACETONIDE MYLAN Manufacturing (CMC) Approval
04/22/2016 AN-SULFUR COLLOID
NDA #017858		 SUPPL-40 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
04/22/2016 HUMULIN N
BLA #018781		 SUPPL-161 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/22/2016 CORDARONE
NDA #018972		 SUPPL-51 AMIODARONE HYDROCHLORIDE WYETH PHARMS Labeling Approval
04/22/2016 CAPEX
NDA #020001		 SUPPL-13 FLUOCINOLONE ACETONIDE GALDERMA LABS LP Manufacturing (CMC) Approval
04/22/2016 RHINOCORT
NDA #020746		 SUPPL-34 BUDESONIDE J AND J CONSUMER INC Labeling Approval
04/22/2016 RHINOCORT ALLERGY
NDA #020746		 SUPPL-34 BUDESONIDE J AND J CONSUMER INC Labeling Approval
04/22/2016 THALOMID
NDA #020785		 SUPPL-60 THALIDOMIDE BRISTOL-MYERS REMS Approval
04/22/2016 SOMAVERT
BLA #021106		 SUPPL-50 PEGVISOMANT PHARMACIA Approval
04/22/2016 ZOMETA
NDA #021223		 SUPPL-33 ZOLEDRONIC ACID NOVARTIS Manufacturing (CMC) Approval
04/22/2016 AEROSPAN HFA
NDA #021247		 SUPPL-14 FLUNISOLIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/22/2016 CIALIS
NDA #021368		 SUPPL-27 TADALAFIL LILLY Labeling Approval
04/22/2016 RANEXA
NDA #021526		 SUPPL-33 RANOLAZINE MENARINI INTL Manufacturing (CMC) Approval
04/22/2016 REVLIMID
NDA #021880		 SUPPL-47 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
04/22/2016 VICTOZA
NDA #022341		 SUPPL-25 LIRAGLUTIDE NOVO NORDISK INC Efficacy Approval
04/22/2016 ESOMEPRAZOLE MAGNESIUM
ANDA #078279		 SUPPL-3 ESOMEPRAZOLE MAGNESIUM DR REDDYS Manufacturing (CMC) Approval
04/22/2016 FOMEPIZOLE
ANDA #078537		 SUPPL-4 FOMEPIZOLE NAVINTA LLC Manufacturing (CMC) Approval
04/22/2016 THIORIDAZINE HYDROCHLORIDE
ANDA #088137		 SUPPL-20 THIORIDAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/22/2016 NITHIODOTE
NDA #201444		 SUPPL-18 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
04/22/2016 LATANOPROST
ANDA #202442		 ORIG-1 LATANOPROST FDC LTD Approval
04/22/2016 POMALYST
NDA #204026		 SUPPL-13 POMALIDOMIDE BRISTOL REMS Approval
04/22/2016 TIVICAY
NDA #204790		 SUPPL-7 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
04/22/2016 MILNACIPRAN HYDROCHLORIDE
ANDA #205081		 ORIG-1 MILNACIPRAN HYDROCHLORIDE AMNEAL PHARMS Approval
04/22/2016 TELMISARTAN
ANDA #205901		 ORIG-1 TELMISARTAN HETERO LABS LTD V Approval
04/22/2016 ORFADIN
NDA #206356		 ORIG-1 NITISINONE SWEDISH ORPHAN Type 3 - New Dosage Form Approval
04/22/2016 VARUBI
NDA #206500		 SUPPL-2 ROLAPITANT HYDROCHLORIDE TERSERA Manufacturing (CMC) Approval
04/22/2016 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #206512		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN AUROBINDO PHARMA Approval
04/22/2016 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-9 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Efficacy Approval
04/22/2016 LENVIMA
NDA #206947		 SUPPL-4 LENVATINIB MESYLATE EISAI INC Labeling Approval
04/22/2016 NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
ANDA #208097		 ORIG-1 NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;ETHINYL ESTRADIOL;FERROUS FUMARATE GLENMARK PHARMS LTD Tentative Approval
04/25/2016 LIMBITROL
NDA #016949		 SUPPL-39 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
04/25/2016 LIMBITROL DS
NDA #016949		 SUPPL-39 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
04/25/2016 WELLBUTRIN
NDA #018644		 SUPPL-50 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
04/25/2016 WELLBUTRIN SR
NDA #020358		 SUPPL-57 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
04/25/2016 ATNAA
NDA #021175		 SUPPL-30 ATROPINE; PRALIDOXIME CHLORIDE US ARMY Manufacturing (CMC) Approval
04/25/2016 FAZACLO ODT
NDA #021590		 SUPPL-29 CLOZAPINE JAZZ Manufacturing (CMC) Approval
04/25/2016 NASCOBAL
NDA #021642		 SUPPL-24 CYANOCOBALAMIN ENDO OPERATIONS Manufacturing (CMC) Approval
04/25/2016 DUODOTE
NDA #021983		 SUPPL-20 ATROPINE; PRALIDOXIME CHLORIDE MMT Manufacturing (CMC) Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #040218		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #040816		 SUPPL-6 AMITRIPTYLINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070297		 SUPPL-28 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070765		 SUPPL-22 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE ANDA REPOSITORY Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070766		 SUPPL-18 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE ANDA REPOSITORY Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071062		 SUPPL-24 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071063		 SUPPL-24 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071064		 SUPPL-19 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071077		 SUPPL-29 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071078		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071079		 SUPPL-28 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071297		 SUPPL-31 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE MYLAN PHARMS INC Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071443		 SUPPL-30 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE MYLAN Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071862		 SUPPL-18 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071863		 SUPPL-18 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072052		 SUPPL-9 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE HERITAGE PHARMA Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072053		 SUPPL-9 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE HERITAGE PHARMA Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072277		 SUPPL-12 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
04/25/2016 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072278		 SUPPL-12 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073007		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073008		 SUPPL-25 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073009		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
04/25/2016 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073010		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085031		 SUPPL-287 AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085032		 SUPPL-309 AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS INC Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085968		 SUPPL-98 AMITRIPTYLINE HYDROCHLORIDE SANDOZ Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085970		 SUPPL-74 AMITRIPTYLINE HYDROCHLORIDE SANDOZ Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086009		 SUPPL-67 AMITRIPTYLINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #089399		 SUPPL-43 AMITRIPTYLINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
04/25/2016 FLUOCINOLONE ACETONIDE
ANDA #090982		 ORIG-1 FLUOCINOLONE ACETONIDE LYNE Approval
04/25/2016 AMITRIPTYLINE HYDROCHLORIDE
ANDA #202446		 SUPPL-1 AMITRIPTYLINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
04/25/2016 MARQIBO KIT
NDA #202497		 SUPPL-6 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
04/25/2016 FLUOCINOLONE ACETONIDE
ANDA #203377		 ORIG-1 FLUOCINOLONE ACETONIDE LYNE Approval
04/25/2016 FLUOCINOLONE ACETONIDE
ANDA #203378		 ORIG-1 FLUOCINOLONE ACETONIDE LYNE Approval
04/25/2016 SAVAYSA
NDA #206316		 SUPPL-7 EDOXABAN TOSYLATE DAIICHI SANKYO INC Manufacturing (CMC) Approval
04/25/2016 BEVESPI AEROSPHERE
NDA #208294		 ORIG-1 FORMOTEROL FUMARATE; GLYCOPYRROLATE ASTRAZENECA Type 4 - New Combination Approval
04/25/2016 TRIFERIC
NDA #208551		 ORIG-1 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Type 3 - New Dosage Form Approval
04/25/2016 CABOMETYX
NDA #208692		 ORIG-1 CABOZANTINIB S-MALATE EXELIXIS INC Type 3 - New Dosage Form Approval
04/26/2016 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-41 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/2016 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-41 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/2016 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-41 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/2016 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-41 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/2016 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-41 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/2016 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075624		 SUPPL-23 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE RISING Labeling Approval
04/26/2016 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075624		 SUPPL-24 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE RISING Labeling Approval
04/26/2016 GLIPIZIDE
ANDA #075795		 SUPPL-12 GLIPIZIDE APOTEX Labeling Approval
04/26/2016 FAMOTIDINE
ANDA #077351		 SUPPL-18 FAMOTIDINE PERRIGO R AND D Manufacturing (CMC) Approval
04/26/2016 GLIMEPIRIDE
ANDA #077624		 SUPPL-5 GLIMEPIRIDE MYLAN Labeling Approval
04/26/2016 NADOLOL AND BENDROFLUMETHIAZIDE
ANDA #077833		 SUPPL-8 BENDROFLUMETHIAZIDE; NADOLOL IMPAX LABS Labeling Approval
04/26/2016 AMLODIPINE BESYLATE
ANDA #078081		 SUPPL-1 AMLODIPINE BESYLATE SUN PHARM INDUSTRIES Labeling Approval
04/26/2016 CARVEDILOL
ANDA #078165		 SUPPL-8 CARVEDILOL RUBICON Labeling Approval
04/26/2016 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #078201		 SUPPL-4 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE RUBICON Labeling Approval
04/26/2016 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #078201		 SUPPL-12 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE RUBICON Labeling Approval
04/26/2016 CARVEDILOL
ANDA #078227		 SUPPL-12 CARVEDILOL SANDOZ Labeling Approval
04/26/2016 SIMPONI ARIA
BLA #125433		 SUPPL-16 GOLIMUMAB JANSSEN BIOTECH Approval
04/26/2016 OXYMORPHONE HYDROCHLORIDE
ANDA #204459		 ORIG-1 OXYMORPHONE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
04/26/2016 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205588		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN LTD Approval
04/26/2016 ACTICLATE
NDA #205931		 SUPPL-2 DOXYCYCLINE HYCLATE CHARTWELL RX Labeling Approval
04/26/2016 FAMOTIDINE
ANDA #206531		 ORIG-1 FAMOTIDINE AUROBINDO PHARMA Approval
04/26/2016 XTAMPZA ER
NDA #208090		 ORIG-1 OXYCODONE COLLEGIUM PHARM INC Type 5 - New Formulation or New Manufacturer Approval
04/26/2016 ACTICLATE CAP
NDA #208253		 ORIG-1 DOXYCYCLINE HYCLATE CHARTWELL RX Type 5 - New Formulation or New Manufacturer Approval
04/27/2016 DESFERAL
NDA #016267		 SUPPL-52 DEFEROXAMINE MESYLATE NOVARTIS Manufacturing (CMC) Approval
04/27/2016 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016366		 SUPPL-215 SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
04/27/2016 RINGER'S IN PLASTIC CONTAINER
NDA #016693		 SUPPL-98 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/27/2016 BSS PLUS
NDA #018469		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Labeling Approval
04/27/2016 TRANDATE
NDA #018716		 SUPPL-28 LABETALOL HYDROCHLORIDE ALVOGEN Labeling Approval
04/27/2016 ARANESP
BLA #103951		 SUPPL-5370 DARBEPOETIN ALFA AMGEN Approval
04/27/2016 KEPIVANCE
BLA #125103		 SUPPL-170 PALIFERMIN BIOVITRUM AB Approval
04/27/2016 GADAVIST
NDA #201277		 SUPPL-11 GADOBUTROL BAYER HLTHCARE Efficacy Approval
04/27/2016 TEMOZOLOMIDE
ANDA #206309		 ORIG-1 TEMOZOLOMIDE RISING Approval
04/28/2016 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-72 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/28/2016 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-72 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/28/2016 BICNU
NDA #017422		 SUPPL-50 CARMUSTINE AVET LIFESCIENCES Labeling Approval
04/28/2016 PEDIAMYCIN
ANDA #062304		 SUPPL-32 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
04/28/2016 PEDIAMYCIN 400
ANDA #062304		 SUPPL-32 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
04/28/2016 GALANTAMINE HYDROBROMIDE
ANDA #077590		 SUPPL-10 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
04/28/2016 GALANTAMINE HYDROBROMIDE
ANDA #077605		 SUPPL-9 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-14 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-15 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-16 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-17 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-18 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 VALPROIC ACID
ANDA #077960		 SUPPL-19 VALPROIC ACID LANNETT CO INC Labeling Approval
04/28/2016 GALANTAMINE HYDROBROMIDE
ANDA #078189		 SUPPL-11 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
04/28/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ZENNOVA Labeling Approval
04/28/2016 GALANTAMINE HYDROBROMIDE
ANDA #090900		 SUPPL-6 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
04/28/2016 NEULASTA
BLA #125031		 SUPPL-184 PEGFILGRASTIM AMGEN Approval
04/28/2016 CIMZIA
BLA #125160		 SUPPL-241 CERTOLIZUMAB PEGOL UCB INC Approval
04/28/2016 MIRCERA
BLA #125164		 SUPPL-71 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
04/28/2016 MIRCERA
BLA #125164		 SUPPL-72 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
04/28/2016 MIRCERA
BLA #125164		 SUPPL-73 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
04/28/2016 KADCYLA
BLA #125427		 SUPPL-94 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
04/28/2016 VALGANCICLOVIR HYDROCHLORIDE
ANDA #200790		 SUPPL-1 VALGANCICLOVIR HYDROCHLORIDE STRIDES PHARMA Labeling Approval
04/28/2016 XALKORI
NDA #202570		 SUPPL-18 CRIZOTINIB PF PRISM CV Labeling Approval
04/28/2016 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202633		 SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
04/28/2016 OMEPRAZOLE MAGNESIUM
ANDA #204152		 SUPPL-1 OMEPRAZOLE MAGNESIUM PERRIGO R AND D Labeling Approval
04/28/2016 HYDRALAZINE HYDROCHLORIDE
ANDA #204680		 ORIG-1 HYDRALAZINE HYDROCHLORIDE MYLAN INSTITUTIONAL Approval
04/28/2016 AZACITIDINE
ANDA #204949		 ORIG-1 AZACITIDINE MYLAN INSTITUTIONAL Approval
04/28/2016 PROAIR DIGIHALER
NDA #205636		 SUPPL-4 ALBUTEROL SULFATE TEVA BRANDED PHARM Efficacy Approval
04/28/2016 PROAIR RESPICLICK
NDA #205636		 SUPPL-4 ALBUTEROL SULFATE TEVA BRANDED PHARM Efficacy Approval
04/28/2016 DICLOFENAC SODIUM
ANDA #206298		 ORIG-1 DICLOFENAC SODIUM TARO Approval
04/29/2016 ADVIL
NDA #018989		 SUPPL-85 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
04/29/2016 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-28 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Manufacturing (CMC) Approval
04/29/2016 ADVAIR DISKUS 100/50
NDA #021077		 SUPPL-54 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/29/2016 ADVAIR DISKUS 250/50
NDA #021077		 SUPPL-54 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/29/2016 ADVAIR DISKUS 500/50
NDA #021077		 SUPPL-54 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/29/2016 ENTOCORT EC
NDA #021324		 SUPPL-12 BUDESONIDE PADAGIS US Efficacy Approval
04/29/2016 ENTOCORT EC
NDA #021324		 SUPPL-13 BUDESONIDE PADAGIS US Efficacy Approval
04/29/2016 SPIRIVA
NDA #021395		 SUPPL-42 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/29/2016 ATROVENT HFA
NDA #021527		 SUPPL-26 IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/29/2016 TOBI
NDA #050753		 SUPPL-19 TOBRAMYCIN MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/29/2016 ROSIGLITAZONE
ANDA #076748		 ORIG-1 ROSIGLITAZONE MALEATE DR REDDYS LABS INC Tentative Approval
04/29/2016 ROSUVASTATIN CALCIUM
ANDA #079167		 ORIG-1 ROSUVASTATIN CALCIUM WATSON LABS INC Approval
04/29/2016 METFORMIN HYDROCHLORIDE
ANDA #090295		 ORIG-1 METFORMIN HYDROCHLORIDE MARKSANS PHARMA Approval
04/29/2016 DOXYCYCLINE HYCLATE
ANDA #090431		 SUPPL-5 DOXYCYCLINE HYCLATE RISING Manufacturing (CMC) Approval
04/29/2016 JENTADUETO
NDA #201281		 SUPPL-12 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/29/2016 XALKORI
NDA #202570		 SUPPL-17 CRIZOTINIB PF PRISM CV Labeling Approval
04/29/2016 PROPAFENONE HYDROCHLORIDE
ANDA #203803		 ORIG-1 PROPAFENONE HYDROCHLORIDE MYLAN Approval
04/29/2016 XOFIGO
NDA #203971		 SUPPL-9 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
04/29/2016 ZOLEDRONIC ACID
NDA #204016		 SUPPL-1 ZOLEDRONIC ACID HOSPIRA Manufacturing (CMC) Approval
04/29/2016 BUDESONIDE
ANDA #204548		 SUPPL-1 BUDESONIDE TEVA PHARMS USA Manufacturing (CMC) Approval
04/29/2016 NUPLAZID
NDA #207318		 ORIG-1 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Type 1 - New Molecular Entity Approval
04/29/2016 AZACITIDINE
NDA #208216		 ORIG-1 AZACITIDINE ACTAVIS LLC Type 5 - New Formulation or New Manufacturer Approval
04/29/2016 OTOVEL
NDA #208251		 ORIG-1 CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE LABORATORIOS SALVAT Type 5 - New Formulation or New Manufacturer Approval
04/29/2016 FYCOMPA
NDA #208277		 ORIG-1 PERAMPANEL CATALYST PHARMS Type 3 - New Dosage Form Approval
04/29/2016 AKOVAZ
NDA #208289		 ORIG-1 EPHEDRINE SULFATE EXELA PHARMA Type 7 - Drug Already Marketed without Approved NDA Approval
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