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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 2014

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 October 09, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2014 HUMALOG
BLA #020563		 SUPPL-147 INSULIN LISPRO RECOMBINANT LILLY Approval
04/01/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-147 INSULIN LISPRO RECOMBINANT LILLY Approval
04/01/2014 HUMALOG PEN
BLA #020563		 SUPPL-147 INSULIN LISPRO RECOMBINANT LILLY Approval
04/01/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-147 INSULIN LISPRO RECOMBINANT LILLY Approval
04/01/2014 ZOVIRAX
NDA #021478		 SUPPL-7 ACYCLOVIR BAUSCH Labeling Approval
04/01/2014 CEFTAZIDIME IN DEXTROSE CONTAINER
NDA #050823		 SUPPL-3 CEFTAZIDIME B BRAUN Manufacturing (CMC) Approval
04/01/2014 CIPROFLOXACIN HYDROCHLORIDE
ANDA #077859		 SUPPL-15 CIPROFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
04/01/2014 ZOLPIDEM TARTRATE
ANDA #078148		 SUPPL-7 ZOLPIDEM TARTRATE PH HEALTH Labeling Approval
04/01/2014 FUROSEMIDE
ANDA #091258		 ORIG-1 FUROSEMIDE SUN PHARM INDS INC Approval
04/01/2014 ZYTIGA
NDA #202379		 SUPPL-10 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
04/01/2014 BRISDELLE
NDA #204516		 SUPPL-2 PAROXETINE MESYLATE LEGACY Manufacturing (CMC) Approval
04/02/2014 HALOG
NDA #017556		 SUPPL-41 HALCINONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/02/2014 BUDESONIDE
ANDA #090379		 ORIG-1 BUDESONIDE BARR LABS DIV TEVA Approval
04/02/2014 SOLIFENACIN SUCCINATE
ANDA #091464		 ORIG-1 SOLIFENACIN SUCCINATE TEVA PHARMS USA Approval
04/02/2014 INTRON A
BLA #103132		 SUPPL-5183 INTERFERON ALFA-2B SCHERING Approval
04/02/2014 CLONIDINE HYDROCHLORIDE
ANDA #202983		 ORIG-1 CLONIDINE HYDROCHLORIDE PH HEALTH Approval
04/03/2014 DILANTIN-125
NDA #008762		 SUPPL-51 PHENYTOIN VIATRIS Labeling Approval
04/03/2014 DILANTIN-30
NDA #008762		 SUPPL-51 PHENYTOIN VIATRIS Labeling Approval
04/03/2014 DILANTIN
NDA #010151		 SUPPL-39 PHENYTOIN SODIUM PARKE DAVIS Labeling Approval
04/03/2014 HUMULIN N
BLA #018781		 SUPPL-142 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/03/2014 HUMULIN 70/30
BLA #019717		 SUPPL-121 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/03/2014 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-121 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/03/2014 OMNISCAN
NDA #020123		 SUPPL-41 GADODIAMIDE GE HEALTHCARE Manufacturing (CMC) Approval
04/03/2014 SABRIL
NDA #020427		 SUPPL-13 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
04/03/2014 HUMALOG
BLA #020563		 SUPPL-148 INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-148 INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 HUMALOG PEN
BLA #020563		 SUPPL-148 INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-148 INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 XALATAN
NDA #020597		 SUPPL-49 LATANOPROST UPJOHN Manufacturing (CMC) Approval
04/03/2014 HUMALOG MIX 50/50
BLA #021018		 SUPPL-92 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-92 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-92 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/03/2014 SURFAXIN
NDA #021746		 SUPPL-4 LUCINACTANT LEES PHARM HK Manufacturing (CMC) Approval
04/03/2014 SABRIL
NDA #022006		 SUPPL-14 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
04/03/2014 BENLYSTA
BLA #125370		 SUPPL-53 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
04/03/2014 MOXIFLOXACIN HYDROCHLORIDE
ANDA #200160		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE TORRENT Approval
04/03/2014 NIFEDIPINE
ANDA #203126		 ORIG-1 NIFEDIPINE TWI PHARMS Approval
04/03/2014 NEVIRAPINE
ANDA #203411		 ORIG-1 NEVIRAPINE SANDOZ Approval
04/03/2014 NEVIRAPINE
ANDA #205258		 ORIG-1 NEVIRAPINE APOTEX Approval
04/03/2014 EVZIO
NDA #205787		 ORIG-1 NALOXONE HYDROCHLORIDE KALEO INC Type 3 - New Dosage Form and Type 4 - New Combination Approval
04/04/2014 LIPIODOL
NDA #009190		 SUPPL-24 ETHIODIZED OIL GUERBET Efficacy Approval
04/04/2014 SOLU-CORTEF
NDA #009866		 SUPPL-95 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
04/04/2014 SOLU-MEDROL
NDA #011856		 SUPPL-116 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
04/04/2014 LUNESTA
NDA #021476		 SUPPL-25 ESZOPICLONE WAYLIS THERAP Manufacturing (CMC) Approval
04/04/2014 SYMBICORT
NDA #021929		 SUPPL-37 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE ASTRAZENECA Manufacturing (CMC) Approval
04/04/2014 PRADAXA
NDA #022512		 SUPPL-18 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Efficacy Approval
04/04/2014 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040736		 SUPPL-12 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Labeling Approval
04/04/2014 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040826		 SUPPL-4 ACETAMINOPHEN; HYDROCODONE BITARTRATE SUN PHARM INDS LTD Labeling Approval
04/04/2014 CLEOCIN
NDA #050537		 SUPPL-35 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
04/04/2014 CLEOCIN T
NDA #050537		 SUPPL-35 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
04/04/2014 CLEOCIN T
NDA #050600		 SUPPL-13 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
04/04/2014 CLEOCIN T
NDA #050615		 SUPPL-12 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
04/04/2014 AUGMENTIN XR
NDA #050785		 SUPPL-15 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
04/04/2014 METHOTREXATE SODIUM
ANDA #081235		 SUPPL-19 METHOTREXATE SODIUM MYLAN Labeling Approval
04/04/2014 VALACYCLOVIR HYDROCHLORIDE
ANDA #090500		 ORIG-1 VALACYCLOVIR HYDROCHLORIDE APOTEX Approval
04/04/2014 NEURACEQ
NDA #204677		 SUPPL-1 FLORBETABEN F-18 LANTHEUS Labeling Approval
04/07/2014 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018388		 SUPPL-85 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/07/2014 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018388		 SUPPL-85 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/07/2014 LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018388		 SUPPL-85 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/07/2014 ZOMETA
NDA #021223		 SUPPL-28 ZOLEDRONIC ACID NOVARTIS Labeling Approval
04/07/2014 VFEND
NDA #021266		 SUPPL-37 VORICONAZOLE PF PRISM CV Labeling Approval
04/07/2014 VFEND
NDA #021267		 SUPPL-44 VORICONAZOLE PF PRISM CV Labeling Approval
04/07/2014 VFEND
NDA #021630		 SUPPL-27 VORICONAZOLE PF PRISM CV Labeling Approval
04/07/2014 APTIVUS
NDA #021814		 SUPPL-14 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
04/07/2014 PREZISTA
NDA #021976		 SUPPL-34 DARUNAVIR JANSSEN PRODS Labeling Approval
04/07/2014 TORISEL
NDA #022088		 SUPPL-16 TEMSIROLIMUS PF PRISM CV Labeling Approval
04/07/2014 APTIVUS
NDA #022292		 SUPPL-7 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
04/07/2014 VIIBRYD
NDA #022567		 SUPPL-11 VILAZODONE HYDROCHLORIDE ABBVIE Labeling Approval
04/07/2014 LAZANDA
NDA #022569		 SUPPL-18 FENTANYL CITRATE BTCP PHARMA Manufacturing (CMC) Approval
04/07/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #078778		 ORIG-1 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE SENORES PHARMS Approval
04/07/2014 NIMODIPINE
ANDA #090103		 ORIG-1 NIMODIPINE THEPHARMANETWORK LLC Approval
04/07/2014 HYDROCHLOROTHIAZIDE
ANDA #090651		 ORIG-1 HYDROCHLOROTHIAZIDE SUN PHARM INDS INC Approval
04/07/2014 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-7 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
04/07/2014 OMEGA-3-ACID ETHYL ESTERS
ANDA #091028		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS RENOVA PHARMS Approval
04/07/2014 NAFCILLIN SODIUM
ANDA #200002		 ORIG-1 NAFCILLIN SODIUM ONESOURCE SPECIALTY Approval
04/07/2014 AMPICILLIN AND SULBACTAM
ANDA #201024		 ORIG-1 AMPICILLIN SODIUM; SULBACTAM SODIUM ONESOURCE SPECIALTY Approval
04/07/2014 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-7 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
04/07/2014 AMPICILLIN AND SULBACTAM
ANDA #202197		 ORIG-1 AMPICILLIN SODIUM; SULBACTAM SODIUM ONESOURCE SPECIALTY Approval
04/07/2014 AMPICILLIN SODIUM
ANDA #202198		 ORIG-1 AMPICILLIN SODIUM ONESOURCE SPECIALTY Approval
04/07/2014 PREZISTA
NDA #202895		 SUPPL-11 DARUNAVIR JANSSEN PRODS Labeling Approval
04/07/2014 PIOGLITAZONE HYDROCHLORIDE
ANDA #204133		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE ANNORA PHARMA Approval
04/08/2014 ORTHO-CEPT
NDA #020301		 SUPPL-33 DESOGESTREL; ETHINYL ESTRADIOL JANSSEN PHARMS Manufacturing (CMC) Approval
04/08/2014 SYNTHROID
NDA #021402		 SUPPL-26 LEVOTHYROXINE SODIUM ABBVIE Manufacturing (CMC) Approval
04/08/2014 ISENTRESS
NDA #022145		 SUPPL-32 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/08/2014 ISENTRESS HD
NDA #022145		 SUPPL-32 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/08/2014 AUGMENTIN ES-600
NDA #050755		 SUPPL-20 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
04/08/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #074703		 SUPPL-10 METOCLOPRAMIDE HYDROCHLORIDE PHARMOBEDIENT CNSLTG Labeling Approval
04/08/2014 OXALIPLATIN
ANDA #202922		 ORIG-1 OXALIPLATIN SUN PHARM Approval
04/08/2014 ISENTRESS
NDA #203045		 SUPPL-10 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/08/2014 KALYDECO
NDA #203188		 SUPPL-8 IVACAFTOR VERTEX PHARMS Labeling Approval
04/08/2014 ISENTRESS
NDA #205786		 SUPPL-1 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/09/2014 DIAMOX
NDA #012945		 SUPPL-46 ACETAZOLAMIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
04/09/2014 EXELON
NDA #020823		 SUPPL-31 RIVASTIGMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
04/09/2014 ORAVERSE
NDA #022159		 SUPPL-7 PHENTOLAMINE MESYLATE SEPTODONT HOLDING Manufacturing (CMC) Approval
04/09/2014 RIBAVIRIN
ANDA #077456		 SUPPL-14 RIBAVIRIN CHARTWELL RX Manufacturing (CMC) Approval
04/09/2014 BUTALBITAL AND ACETAMINOPHEN
ANDA #090956		 SUPPL-1 ACETAMINOPHEN; BUTALBITAL LGM PHARMA Labeling Approval
04/09/2014 AMPICILLIN SODIUM
ANDA #201025		 ORIG-1 AMPICILLIN SODIUM ONESOURCE SPECIALTY Approval
04/09/2014 VICTRELIS
NDA #202258		 SUPPL-11 BOCEPREVIR MERCK SHARP DOHME Efficacy Approval
04/09/2014 GATIFLOXACIN
ANDA #203190		 ORIG-1 GATIFLOXACIN HI-TECH PHARMACAL Tentative Approval
04/09/2014 ZOLMITRIPTAN
ANDA #204284		 ORIG-1 ZOLMITRIPTAN INVAGEN PHARMS Approval
04/10/2014 SPRYCEL
NDA #021986		 SUPPL-14 DASATINIB BRISTOL MYERS SQUIBB Labeling Approval
04/10/2014 PROMACTA
NDA #022291		 SUPPL-11 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
04/10/2014 OFLOXACIN
ANDA #076182		 SUPPL-14 OFLOXACIN TEVA Labeling Approval
04/11/2014 PREMARIN
NDA #004782		 SUPPL-163 ESTROGENS, CONJUGATED WYETH PHARMS Manufacturing (CMC) Approval
04/11/2014 HUMULIN N
BLA #018781		 SUPPL-143 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/11/2014 HUMATROPE
BLA #019640		 SUPPL-95 SOMATROPIN LILLY Approval
04/11/2014 HUMULIN 70/30
BLA #019717		 SUPPL-122 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/11/2014 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-122 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
04/11/2014 SPORANOX
NDA #020083		 SUPPL-54 ITRACONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
04/11/2014 HUMALOG
BLA #020563		 SUPPL-149 INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-149 INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG PEN
BLA #020563		 SUPPL-149 INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-149 INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 75/25
BLA #021017		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 50/50
BLA #021018		 SUPPL-93 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-93 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-93 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/11/2014 ORTHO EVRA
NDA #021180		 SUPPL-46 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Labeling Approval
04/11/2014 XYREM
NDA #021196		 SUPPL-19 SODIUM OXYBATE JAZZ PHARMS Efficacy Approval
04/11/2014 FORTEO
NDA #021318		 SUPPL-39 TERIPARATIDE LILLY Manufacturing (CMC) Approval
04/11/2014 VIMPAT
NDA #022255		 SUPPL-15 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
04/11/2014 FORTAZ IN PLASTIC CONTAINER
NDA #050634		 SUPPL-27 CEFTAZIDIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
04/11/2014 LIDOCAINE HYDROCHLORIDE
ANDA #202242		 ORIG-1 LIDOCAINE HYDROCHLORIDE RISING Approval
04/11/2014 CLOPIDOGREL BISULFATE
ANDA #203751		 ORIG-1 CLOPIDOGREL BISULFATE AMNEAL PHARMS Approval
04/14/2014 KADIAN
NDA #020616		 SUPPL-52 MORPHINE SULFATE ALLERGAN Manufacturing (CMC) Approval
04/14/2014 SEREVENT
NDA #020692		 SUPPL-43 SALMETEROL XINAFOATE GLAXOSMITHKLINE Labeling Approval
04/14/2014 FLOVENT DISKUS 100
NDA #020833		 SUPPL-28 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
04/14/2014 FLOVENT DISKUS 250
NDA #020833		 SUPPL-28 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
04/14/2014 FLOVENT DISKUS 50
NDA #020833		 SUPPL-28 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
04/14/2014 ADVAIR DISKUS 100/50
NDA #021077		 SUPPL-51 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/14/2014 ADVAIR DISKUS 250/50
NDA #021077		 SUPPL-51 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/14/2014 ADVAIR DISKUS 500/50
NDA #021077		 SUPPL-51 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
04/14/2014 TARCEVA
NDA #021743		 SUPPL-19 ERLOTINIB HYDROCHLORIDE OSI PHARMS Labeling Approval
04/14/2014 SELZENTRY
NDA #022128		 SUPPL-13 MARAVIROC VIIV HLTHCARE Manufacturing (CMC) Approval
04/14/2014 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-47 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
04/14/2014 SUMATRIPTAN SUCCINATE
ANDA #203322		 ORIG-1 SUMATRIPTAN SUCCINATE PHARMOBEDIENT Approval
04/14/2014 MINASTRIN 24 FE
NDA #203667		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
04/14/2014 DIAZEPAM
ANDA #204433		 ORIG-1 DIAZEPAM CHARTWELL MOLECULAR Approval
04/14/2014 ZORVOLEX
NDA #204592		 SUPPL-1 DICLOFENAC ZYLA Manufacturing (CMC) Approval
04/15/2014 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-22 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Labeling Approval
04/15/2014 NEURONTIN
NDA #021129		 SUPPL-41 GABAPENTIN VIATRIS Manufacturing (CMC) Approval
04/15/2014 ELIGARD KIT
NDA #021379		 SUPPL-28 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
04/15/2014 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #091003		 ORIG-1 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TEVA PHARMS USA Tentative Approval
04/15/2014 ESZOPICLONE
ANDA #091024		 ORIG-1 ESZOPICLONE DR REDDYS Approval
04/15/2014 ESZOPICLONE
ANDA #091153		 ORIG-1 ESZOPICLONE HIKMA PHARMS Approval
04/15/2014 ESZOPICLONE
ANDA #091166		 ORIG-1 ESZOPICLONE GLENMARK PHARMS LTD Approval
04/15/2014 NULOJIX
BLA #125288		 SUPPL-59 BELATACEPT BRISTOL MYERS SQUIBB Approval
04/15/2014 TANZEUM
BLA #125431		 ORIG-1 ALBIGLUTIDE GLAXOSMITHKLINE LLC Approval
04/15/2014 RAMIPRIL
ANDA #202392		 ORIG-1 RAMIPRIL ACCORD HLTHCARE Approval
04/16/2014 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-35 METHADONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/16/2014 MS CONTIN
NDA #019516		 SUPPL-42 MORPHINE SULFATE KNOA PHARMA Labeling Approval
04/16/2014 DURAGESIC-100
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 DURAGESIC-12
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 DURAGESIC-25
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 DURAGESIC-37
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 DURAGESIC-50
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 DURAGESIC-75
NDA #019813		 SUPPL-63 FENTANYL JANSSEN PHARMS Labeling Approval
04/16/2014 KADIAN
NDA #020616		 SUPPL-51 MORPHINE SULFATE ALLERGAN Labeling Approval
04/16/2014 CELEXA
NDA #020822		 SUPPL-45 CITALOPRAM HYDROBROMIDE ABBVIE Labeling Approval
04/16/2014 ALLEGRA ALLERGY
NDA #020872		 SUPPL-31 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2014 ALLEGRA HIVES
NDA #020872		 SUPPL-31 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2014 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-31 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2014 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-31 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2014 PALLADONE
NDA #021044		 SUPPL-13 HYDROMORPHONE HYDROCHLORIDE PURDUE PHARMA LP Labeling Approval
04/16/2014 EXALGO
NDA #021217		 SUPPL-13 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
04/16/2014 AVINZA
NDA #021260		 SUPPL-22 MORPHINE SULFATE KING PHARMS LLC Labeling Approval
04/16/2014 BUTRANS
NDA #021306		 SUPPL-18 BUPRENORPHINE KNOA PHARMA Labeling Approval
04/16/2014 OPANA ER
NDA #021610		 SUPPL-18 OXYMORPHONE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
04/16/2014 OXYCONTIN
NDA #022272		 SUPPL-22 OXYCODONE HYDROCHLORIDE KNOA PHARMA Labeling Approval
04/16/2014 EMBEDA
NDA #022321		 SUPPL-17 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Labeling Approval
04/16/2014 PRADAXA
NDA #022512		 SUPPL-20 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/16/2014 CEFADROXIL
ANDA #062695		 SUPPL-10 CEFADROXIL/CEFADROXIL HEMIHYDRATE TEVA Labeling Approval
04/16/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-13 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
04/16/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-12 OXYMORPHONE HYDROCHLORIDE IMPAX LABS Labeling Approval
04/16/2014 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-33 METHADONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/16/2014 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-24 METHADONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/16/2014 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-28 METHADONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/16/2014 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-3 METHADONE HYDROCHLORIDE VISTAPHARM LLC Labeling Approval
04/16/2014 NUCYNTA ER
NDA #200533		 SUPPL-10 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
04/16/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 SUPPL-1 OXYMORPHONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/16/2014 XULANE
ANDA #200910		 ORIG-1 ETHINYL ESTRADIOL; NORELGESTROMIN MYLAN TECHNOLOGIES Approval
04/16/2014 OPANA ER
NDA #201655		 SUPPL-12 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
04/16/2014 LO MINASTRIN FE
NDA #204654		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
04/17/2014 NICORETTE
NDA #018612		 SUPPL-70 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
04/17/2014 NICORETTE (MINT)
NDA #018612		 SUPPL-70 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
04/17/2014 TRENTAL
NDA #018631		 SUPPL-36 PENTOXIFYLLINE VALIDUS PHARMS Labeling Approval
04/17/2014 NICORETTE
NDA #020066		 SUPPL-51 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
04/17/2014 NICORETTE (MINT)
NDA #020066		 SUPPL-51 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
04/17/2014 VIVITROL
NDA #021897		 SUPPL-26 NALTREXONE ALKERMES Manufacturing (CMC) Approval
04/17/2014 COARTEM
NDA #022268		 SUPPL-8 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
04/17/2014 DULERA
NDA #022518		 SUPPL-14 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
04/17/2014 VIIBRYD
NDA #022567		 SUPPL-10 VILAZODONE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
04/17/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-16 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
04/17/2014 ALCLOMETASONE DIPROPIONATE
ANDA #079061		 SUPPL-3 ALCLOMETASONE DIPROPIONATE GLENMARK PHARMS LTD Labeling Approval
04/17/2014 ALCLOMETASONE DIPROPIONATE
ANDA #079227		 SUPPL-2 ALCLOMETASONE DIPROPIONATE GLENMARK PHARMS LTD Labeling Approval
04/17/2014 ARZERRA
BLA #125326		 SUPPL-60 OFATUMUMAB NOVARTIS Approval
04/17/2014 KESIMPTA
BLA #125326		 SUPPL-60 OFATUMUMAB NOVARTIS Approval
04/17/2014 PHENYTOIN
ANDA #200565		 ORIG-1 PHENYTOIN TARO Approval
04/17/2014 ZYTIGA
NDA #202379		 SUPPL-11 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
04/17/2014 VASOSTRICT
NDA #204485		 ORIG-1 VASOPRESSIN PH HEALTH Type 7 - Drug Already Marketed without Approved NDA Approval
04/18/2014 ZINECARD
NDA #020212		 SUPPL-17 DEXRAZOXANE HYDROCHLORIDE PFIZER Labeling Approval
04/18/2014 NASONEX
NDA #020762		 SUPPL-49 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
04/18/2014 PRECEDEX
NDA #021038		 SUPPL-16 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/18/2014 MORPHINE SULFATE
NDA #022195		 SUPPL-8 MORPHINE SULFATE HIKMA PHARMS Manufacturing (CMC) Approval
04/18/2014 CEFADROXIL
ANDA #065260		 SUPPL-5 CEFADROXIL/CEFADROXIL HEMIHYDRATE HIKMA Labeling Approval
04/18/2014 CEFADROXIL
ANDA #065301		 SUPPL-3 CEFADROXIL/CEFADROXIL HEMIHYDRATE CHARTWELL RX Labeling Approval
04/18/2014 CEFADROXIL
ANDA #065349		 SUPPL-3 CEFADROXIL/CEFADROXIL HEMIHYDRATE AUROBINDO Labeling Approval
04/18/2014 CEFADROXIL
ANDA #065352		 SUPPL-4 CEFADROXIL/CEFADROXIL HEMIHYDRATE AUROBINDO PHARMA Labeling Approval
04/18/2014 CEFADROXIL
ANDA #065396		 SUPPL-12 CEFADROXIL/CEFADROXIL HEMIHYDRATE LUPIN Labeling Approval
04/18/2014 CICLOPIROX
ANDA #090490		 SUPPL-3 CICLOPIROX ACTAVIS MID ATLANTIC Labeling Approval
04/18/2014 EDARBI
NDA #200796		 SUPPL-5 AZILSARTAN KAMEDOXOMIL AZURITY Labeling Approval
04/18/2014 TROKENDI XR
NDA #201635		 SUPPL-1 TOPIRAMATE SUPERNUS PHARMS Manufacturing (CMC) Approval
04/18/2014 TROKENDI XR
NDA #201635		 SUPPL-4 TOPIRAMATE SUPERNUS PHARMS Manufacturing (CMC) Approval
04/18/2014 EDARBYCLOR
NDA #202331		 SUPPL-5 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE AZURITY Labeling Approval
04/18/2014 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Manufacturing (CMC) Approval
04/18/2014 MINIVELLE
NDA #203752		 SUPPL-5 ESTRADIOL NOVEN Manufacturing (CMC) Approval
04/21/2014 SSD
NDA #018578		 SUPPL-16 SILVER SULFADIAZINE DR REDDYS Manufacturing (CMC) Approval
04/21/2014 SSD AF
NDA #018578		 SUPPL-16 SILVER SULFADIAZINE DR REDDYS Manufacturing (CMC) Approval
04/21/2014 LOTRISONE
NDA #018827		 SUPPL-46 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE ORGANON Labeling Approval
04/21/2014 UROXATRAL
NDA #021287		 SUPPL-18 ALFUZOSIN HYDROCHLORIDE ADVANZ PHARMA Labeling Approval
04/21/2014 CADUET
NDA #021540		 SUPPL-33 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Manufacturing (CMC) Approval
04/21/2014 ENDOMETRIN
NDA #022057		 SUPPL-7 PROGESTERONE FERRING Manufacturing (CMC) Approval
04/21/2014 FANAPT
NDA #022192		 SUPPL-13 ILOPERIDONE VANDA PHARMS INC Labeling Approval
04/21/2014 SPRIX
NDA #022382		 SUPPL-9 KETOROLAC TROMETHAMINE COSETTE Labeling Approval
04/21/2014 METHYLPREDNISOLONE ACETATE
ANDA #040719		 SUPPL-5 METHYLPREDNISOLONE ACETATE SANDOZ Labeling Approval
04/21/2014 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-41 CEFOTAXIME SODIUM STERIMAX Manufacturing (CMC) Approval
04/21/2014 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-41 CEFOTAXIME SODIUM STERIMAX Manufacturing (CMC) Approval
04/21/2014 ATRIDOX
NDA #050751		 SUPPL-19 DOXYCYCLINE HYCLATE DEN-MAT Manufacturing (CMC) Approval
04/21/2014 CYRAMZA
BLA #125477		 ORIG-1 RAMUCIRUMAB ELI LILLY AND CO Approval
04/21/2014 PROCYSBI
NDA #203389		 SUPPL-5 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
04/22/2014 ALVESCO
NDA #021658		 SUPPL-8 CICLESONIDE AZURITY Manufacturing (CMC) Approval
04/22/2014 GRIFULVIN V
ANDA #062279		 SUPPL-22 GRISEOFULVIN, MICROCRYSTALLINE VALEANT LUXEMBOURG Labeling Approval
04/22/2014 GRIFULVIN V
ANDA #062279		 SUPPL-22 GRISEOFULVIN, MICROSIZE VALEANT LUXEMBOURG Labeling Approval
04/22/2014 CEFOXITIN
ANDA #065313		 SUPPL-10 CEFOXITIN SODIUM HOSPIRA INC Labeling Approval
04/22/2014 DOXYCYCLINE HYCLATE
ANDA #090134		 SUPPL-11 DOXYCYCLINE HYCLATE ACTAVIS ELIZABETH Labeling Approval
04/22/2014 ATAZANAVIR SULFATE
ANDA #091673		 ORIG-1 ATAZANAVIR SULFATE TEVA PHARMS USA Approval
04/22/2014 ONCASPAR
BLA #103411		 SUPPL-5180 PEGASPARGASE SIGMA TAU Approval
04/22/2014 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-4 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
04/22/2014 HEPARIN SODIUM
NDA #201370		 SUPPL-4 HEPARIN SODIUM PFIZER Labeling Approval
04/22/2014 HEPARIN SODIUM
NDA #201370		 SUPPL-5 HEPARIN SODIUM PFIZER Labeling Approval
04/22/2014 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-4 HEPARIN SODIUM PFIZER Labeling Approval
04/22/2014 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-5 HEPARIN SODIUM PFIZER Labeling Approval
04/22/2014 ZETONNA
NDA #202129		 SUPPL-3 CICLESONIDE AZURITY Manufacturing (CMC) Approval
04/22/2014 MEDICAL AIR, USP
NDA #207036		 ORIG-1 MEDICAL AIR CEE KAY SUPPLY Medical Gas Approval
04/23/2014 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-36 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/23/2014 ADRENACLICK
NDA #020800		 SUPPL-24 EPINEPHRINE IMPAX Labeling Approval
04/23/2014 TWINJECT
NDA #020800		 SUPPL-24 EPINEPHRINE IMPAX Labeling Approval
04/23/2014 DIOVAN HCT
NDA #020818		 SUPPL-59 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
04/23/2014 DEPOCYT
NDA #021041		 SUPPL-27 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
04/23/2014 DEPOCYT
NDA #021041		 SUPPL-28 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
04/23/2014 OLUX
NDA #021142		 SUPPL-19 CLOBETASOL PROPIONATE QUAGEN Labeling Approval
04/23/2014 CLARINEX
NDA #021165		 SUPPL-17 DESLORATADINE ORGANON Labeling Approval
04/23/2014 CLARINEX
NDA #021300		 SUPPL-14 DESLORATADINE ORGANON LLC Labeling Approval
04/23/2014 CLARINEX
NDA #021312		 SUPPL-15 DESLORATADINE ORGANON Labeling Approval
04/23/2014 CLARINEX
NDA #021563		 SUPPL-3 DESLORATADINE SCHERING Labeling Approval
04/23/2014 BYETTA
NDA #021773		 SUPPL-35 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
04/23/2014 KUVAN
NDA #022181		 SUPPL-13 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Efficacy Approval
04/23/2014 TOBRAMYCIN SULFATE
ANDA #065407		 SUPPL-4 TOBRAMYCIN SULFATE MYLAN LABS LTD Labeling Approval
04/23/2014 DIAZEPAM
ANDA #072079		 SUPPL-18 DIAZEPAM HOSPIRA Manufacturing (CMC) Approval
04/23/2014 GABAPENTIN
ANDA #078428		 SUPPL-22 GABAPENTIN AMNEAL PHARMS NY Labeling Approval
04/23/2014 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #090415		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE PH HEALTH Labeling Approval
04/23/2014 SYLVANT
BLA #125496		 ORIG-1 SILTUXIMAB RECORDATI RARE DISEASES, INC. Approval
04/23/2014 NIACIN
ANDA #200484		 ORIG-1 NIACIN SUN PHARM Approval
04/23/2014 NIACIN
ANDA #201273		 ORIG-1 NIACIN SUN PHARM Approval
04/23/2014 DOCETAXEL
NDA #201525		 SUPPL-3 DOCETAXEL SANDOZ Labeling Approval
04/23/2014 SPIRONOLACTONE
ANDA #203253		 ORIG-1 SPIRONOLACTONE JUBILANT GENERICS Approval
04/23/2014 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #203371		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE XIROMED Approval
04/23/2014 JUXTAPID
NDA #203858		 SUPPL-5 LOMITAPIDE MESYLATE CHIESI Manufacturing (CMC) Approval
04/23/2014 OMTRYG
NDA #204977		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Type 5 - New Formulation or New Manufacturer Approval
04/24/2014 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-51 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 CHEMET
NDA #019998		 SUPPL-18 SUCCIMER RECORDATI RARE Manufacturing (CMC) Approval
04/24/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-33 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
04/24/2014 PROVIGIL
NDA #020717		 SUPPL-42 MODAFINIL NUVO PHARMS Manufacturing (CMC) Approval
04/24/2014 ERYTHROMYCIN
ANDA #063038		 SUPPL-4 ERYTHROMYCIN PADAGIS US Labeling Approval
04/24/2014 ZIPRASIDONE HYDROCHLORIDE
ANDA #077560		 SUPPL-5 ZIPRASIDONE HYDROCHLORIDE LUPIN PHARMS Labeling Approval
04/24/2014 ALENDRONATE SODIUM
ANDA #077982		 SUPPL-7 ALENDRONATE SODIUM APOTEX Labeling Approval
04/24/2014 ALENDRONATE SODIUM
ANDA #077982		 SUPPL-8 ALENDRONATE SODIUM APOTEX Labeling Approval
04/24/2014 REBIF
BLA #103780		 SUPPL-5178 INTERFERON BETA-1A SERONO INC Approval
04/24/2014 REBIF
BLA #103780		 SUPPL-5179 INTERFERON BETA-1A SERONO INC Approval
04/24/2014 DESOXIMETASONE
ANDA #201005		 ORIG-1 DESOXIMETASONE EPIC PHARMA LLC Approval
04/24/2014 LAMOTRIGINE
ANDA #201791		 SUPPL-1 LAMOTRIGINE PH HEALTH Labeling Approval
04/25/2014 BICILLIN C-R
NDA #050138		 SUPPL-235 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
04/25/2014 BICILLIN C-R 900/300
NDA #050138		 SUPPL-235 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
04/25/2014 BICILLIN L-A
NDA #050141		 SUPPL-232 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
04/25/2014 TOBI
NDA #050753		 SUPPL-16 TOBRAMYCIN VIATRIS Labeling Approval
04/25/2014 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #062055		 SUPPL-32 ERYTHROMYCIN ETHYLSUCCINATE ANI PHARMS Labeling Approval
04/25/2014 CEFTRIAXONE
ANDA #090057		 ORIG-1 CEFTRIAXONE SODIUM SAMSON MEDCL Approval
04/25/2014 TOBI PODHALER
NDA #201688		 SUPPL-2 TOBRAMYCIN VIATRIS Labeling Approval
04/25/2014 ASMANEX HFA
NDA #205641		 ORIG-1 MOMETASONE FUROATE ORGANON LLC Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approval
04/28/2014 RISPERDAL
NDA #020272		 SUPPL-73 RISPERIDONE JANSSEN PHARMS Labeling Approval
04/28/2014 RISPERDAL
NDA #020588		 SUPPL-62 RISPERIDONE JANSSEN PHARMS Labeling Approval
04/28/2014 RISPERDAL CONSTA
NDA #021346		 SUPPL-51 RISPERIDONE JANSSEN PHARMS Labeling Approval
04/28/2014 RISPERDAL
NDA #021444		 SUPPL-48 RISPERIDONE JANSSEN PHARMS Labeling Approval
04/28/2014 ABRAXANE
NDA #021660		 SUPPL-39 PACLITAXEL BRISTOL-MYERS Manufacturing (CMC) Approval
04/28/2014 SUBOXONE
NDA #022410		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Efficacy Approval
04/28/2014 SUBOXONE
NDA #022410		 SUPPL-17 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Labeling Approval
04/28/2014 SUBOXONE
NDA #022410		 SUPPL-18 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Efficacy Approval
04/28/2014 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078252		 SUPPL-16 CIPROFLOXACIN INFORLIFE Labeling Approval
04/28/2014 GLYDO
ANDA #201094		 ORIG-1 LIDOCAINE HYDROCHLORIDE SAGENT PHARMS INC Approval
04/28/2014 DELZICOL
NDA #204412		 SUPPL-3 MESALAMINE ABBVIE Efficacy Approval
04/28/2014 PURIXAN
NDA #205919		 ORIG-1 MERCAPTOPURINE NOVA LABS LTD Type 5 - New Formulation or New Manufacturer Approval
04/29/2014 ROBAXIN
NDA #011790		 SUPPL-50 METHOCARBAMOL HIKMA PHARMS Manufacturing (CMC) Approval
04/29/2014 TRECATOR
NDA #013026		 SUPPL-28 ETHIONAMIDE WYETH PHARMS Manufacturing (CMC) Approval
04/29/2014 CIALIS
NDA #021368		 SUPPL-23 TADALAFIL LILLY Labeling Approval
04/29/2014 LEVITRA
NDA #021400		 SUPPL-17 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
04/29/2014 INVEGA
NDA #021999		 SUPPL-29 PALIPERIDONE JANSSEN PHARMS Labeling Approval
04/29/2014 ZIRGAN
NDA #022211		 SUPPL-5 GANCICLOVIR BAUSCH AND LOMB Manufacturing (CMC) Approval
04/29/2014 INVEGA SUSTENNA
NDA #022264		 SUPPL-10 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
04/29/2014 ADCIRCA
NDA #022332		 SUPPL-6 TADALAFIL ELI LILLY CO Labeling Approval
04/29/2014 STAXYN
NDA #200179		 SUPPL-2 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
04/29/2014 STENDRA
NDA #202276		 SUPPL-6 AVANAFIL VIVUS LLC Labeling Approval
04/29/2014 LUPANETA PACK
NDA #203696		 SUPPL-3 LEUPROLIDE ACETATE; NORETHINDRONE ACETATE ABBVIE ENDOCRINE Manufacturing (CMC) Approval
04/29/2014 HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #204627		 ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE PADAGIS US Approval
04/29/2014 HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #204658		 ORIG-1 HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE PADAGIS US Approval
04/29/2014 ZYKADIA
NDA #205755		 ORIG-1 CERITINIB NOVARTIS Type 1 - New Molecular Entity Approval
04/30/2014 EPI E Z PEN JR
NDA #019430		 SUPPL-59 EPINEPHRINE VIATRIS Labeling Approval
04/30/2014 EPIPEN
NDA #019430		 SUPPL-59 EPINEPHRINE VIATRIS Labeling Approval
04/30/2014 EPIPEN E Z PEN
NDA #019430		 SUPPL-59 EPINEPHRINE VIATRIS Labeling Approval
04/30/2014 EPIPEN JR.
NDA #019430		 SUPPL-59 EPINEPHRINE VIATRIS Labeling Approval
04/30/2014 CARDENE
NDA #019734		 SUPPL-22 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
04/30/2014 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-22 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
04/30/2014 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-22 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
04/30/2014 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-22 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
04/30/2014 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-22 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
04/30/2014 NICODERM CQ
NDA #020165		 SUPPL-29 NICOTINE CHATTEM SANOFI Labeling Approval
04/30/2014 ACTIQ
NDA #020747		 SUPPL-40 FENTANYL CITRATE CEPHALON Manufacturing (CMC) Approval
04/30/2014 XENICAL
NDA #020766		 SUPPL-34 ORLISTAT CHEPLAPHARM Manufacturing (CMC) Approval
04/30/2014 ALTOPREV
NDA #021316		 SUPPL-31 LOVASTATIN AZURITY Labeling Approval
04/30/2014 BESIVANCE
NDA #022308		 SUPPL-8 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
04/30/2014 GILENYA
NDA #022527		 SUPPL-9 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
04/30/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #040840		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
04/30/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #040841		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
04/30/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #040842		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
04/30/2014 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #040885		 SUPPL-2 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LGM PHARMA Labeling Approval
04/30/2014 DOXYCYCLINE HYCLATE
ANDA #062031		 SUPPL-74 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
04/30/2014 PREVIFEM
ANDA #076334		 SUPPL-20 ETHINYL ESTRADIOL; NORGESTIMATE PH HEALTH Manufacturing (CMC) Approval
04/30/2014 GILDESS 1.5/30
ANDA #077075		 SUPPL-11 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Manufacturing (CMC) Approval
04/30/2014 GILDESS FE 1.5/30
ANDA #077075		 SUPPL-11 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Manufacturing (CMC) Approval
04/30/2014 ORSYTHIA
ANDA #077099		 SUPPL-5 ETHINYL ESTRADIOL; LEVONORGESTREL PH HEALTH Manufacturing (CMC) Approval
04/30/2014 SOLIRIS
BLA #125166		 SUPPL-368 ECULIZUMAB ALEXION PHARM Approval
04/30/2014 SOLIRIS
BLA #125166		 SUPPL-380 ECULIZUMAB ALEXION PHARM Approval
04/30/2014 ELIQUIS
NDA #202155		 SUPPL-7 APIXABAN BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/30/2014 INCRUSE ELLIPTA
NDA #205382		 ORIG-1 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Type 5 - New Formulation or New Manufacturer Approval
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