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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 2015

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 January 20, 2025.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/2015 AMPICILLIN AND SULBACTAM
ANDA #065240		 SUPPL-12 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
03/01/2015 AMPICILLIN AND SULBACTAM
ANDA #065240		 SUPPL-13 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
03/02/2015 VUMON
NDA #020119		 SUPPL-13 TENIPOSIDE HQ SPECLT PHARMA Labeling Approval
03/02/2015 XELODA
NDA #020896		 SUPPL-36 CAPECITABINE CHEPLAPHARM Labeling Approval
03/02/2015 CLARITHROMYCIN
ANDA #065145		 SUPPL-31 CLARITHROMYCIN ACTAVIS LABS FL INC Labeling Approval
03/02/2015 CLARITHROMYCIN
ANDA #065145		 SUPPL-33 CLARITHROMYCIN ACTAVIS LABS FL INC Labeling Approval
03/02/2015 CLARITHROMYCIN
ANDA #065145		 SUPPL-34 CLARITHROMYCIN ACTAVIS LABS FL INC Labeling Approval
03/02/2015 SORINE
ANDA #075500		 SUPPL-14 SOTALOL HYDROCHLORIDE AIPING PHARM INC Labeling Approval
03/02/2015 SORINE
ANDA #075500		 SUPPL-15 SOTALOL HYDROCHLORIDE AIPING PHARM INC Labeling Approval
03/02/2015 DEXTROAMPHETAMINE SULFATE
ANDA #076137		 SUPPL-14 DEXTROAMPHETAMINE SULFATE DR REDDYS LABS SA Labeling Approval
03/02/2015 DEXTROAMPHETAMINE SULFATE
ANDA #076353		 SUPPL-7 DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
03/02/2015 DEXTROAMPHETAMINE SULFATE
ANDA #076353		 SUPPL-8 DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
03/02/2015 MOMETASONE FUROATE
ANDA #076788		 SUPPL-7 MOMETASONE FUROATE TARO Labeling Approval
03/02/2015 ONDANSETRON HYDROCHLORIDE
ANDA #076960		 SUPPL-4 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
03/02/2015 RIBAVIRIN
ANDA #077224		 SUPPL-13 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
03/02/2015 RIBAVIRIN
ANDA #077224		 SUPPL-14 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
03/02/2015 MELOXICAM
ANDA #077927		 SUPPL-17 MELOXICAM UNICHEM Labeling Approval
03/02/2015 NAPROXEN SODIUM
ANDA #078314		 SUPPL-5 NAPROXEN SODIUM GLENMARK PHARMS LTD Labeling Approval
03/02/2015 SILDENAFIL CITRATE
ANDA #078380		 SUPPL-1 SILDENAFIL CITRATE TEVA PHARMS Labeling Approval
03/02/2015 MOEXIPRIL HYDROCHLORIDE
ANDA #078454		 SUPPL-2 MOEXIPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
03/02/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-2 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Labeling Approval
03/02/2015 MOEXIPRIL HYDROCHLORIDE
ANDA #090416		 SUPPL-2 MOEXIPRIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
03/02/2015 MOEXIPRIL HYDROCHLORIDE
ANDA #090416		 SUPPL-3 MOEXIPRIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
03/02/2015 OMEPRAZOLE
ANDA #091352		 SUPPL-8 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
03/02/2015 LANSOPRAZOLE
ANDA #091509		 SUPPL-6 LANSOPRAZOLE SUN PHARM Labeling Approval
03/02/2015 MINOCYCLINE HYDROCHLORIDE
ANDA #202261		 SUPPL-3 MINOCYCLINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/02/2015 OLANZAPINE
ANDA #202937		 ORIG-1 OLANZAPINE ORBION PHARMS Approval
03/02/2015 TELMISARTAN
ANDA #203171		 SUPPL-1 TELMISARTAN TORRENT Labeling Approval
03/02/2015 TELMISARTAN
ANDA #203171		 SUPPL-2 TELMISARTAN TORRENT Labeling Approval
03/02/2015 BREO ELLIPTA
NDA #204275		 SUPPL-2 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Labeling Approval
03/03/2015 XYLOCAINE
NDA #006488		 SUPPL-89 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/03/2015 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-89 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/03/2015 CISPLATIN
NDA #018057		 SUPPL-84 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
03/03/2015 PLATINOL
NDA #018057		 SUPPL-84 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
03/03/2015 PLATINOL-AQ
NDA #018057		 SUPPL-84 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
03/03/2015 IOSAT
NDA #018664		 SUPPL-15 POTASSIUM IODIDE ANBEX Manufacturing (CMC) Approval
03/03/2015 HUMULIN N
BLA #018781		 SUPPL-155 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/03/2015 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-67 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 12
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 140
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 180
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 210
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 240
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 300
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 350
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 70
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 OMNIPAQUE 9
NDA #018956		 SUPPL-94 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/03/2015 SYPRINE
NDA #019194		 SUPPL-12 TRIENTINE HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
03/03/2015 SAIZEN
BLA #019764		 SUPPL-77 SOMATROPIN EMD SERONO Approval
03/03/2015 OXISTAT
NDA #020209		 SUPPL-9 OXICONAZOLE NITRATE ANI PHARMS Manufacturing (CMC) Approval
03/03/2015 TAXOL
NDA #020262		 SUPPL-51 PACLITAXEL HQ SPCLT PHARMA Labeling Approval
03/03/2015 GONAL-F
BLA #020378		 SUPPL-69 FOLLITROPIN ALFA/BETA EMD SERONO Approval
03/03/2015 NASONEX
NDA #020762		 SUPPL-51 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
03/03/2015 REPRONEX
BLA #021047		 SUPPL-14 MENOTROPINS (FSH;LH) FERRING Approval
03/03/2015 ADDERALL XR 10
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 ADDERALL XR 15
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 ADDERALL XR 20
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 ADDERALL XR 25
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 ADDERALL XR 30
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 ADDERALL XR 5
NDA #021303		 SUPPL-28 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/03/2015 CITANEST FORTE DENTAL
NDA #021383		 SUPPL-9 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE DENTSPLY PHARM Manufacturing (CMC) Approval
03/03/2015 ALINIA
NDA #021497		 SUPPL-4 NITAZOXANIDE ROMARK Manufacturing (CMC) Approval
03/03/2015 APIDRA
BLA #021629		 SUPPL-31 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
03/03/2015 APIDRA SOLOSTAR
BLA #021629		 SUPPL-31 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
03/03/2015 AVEED
NDA #022219		 SUPPL-3 TESTOSTERONE UNDECANOATE ENDO OPERATIONS Labeling Approval
03/03/2015 VELETRI
NDA #022260		 SUPPL-7 EPOPROSTENOL SODIUM ACTELION Manufacturing (CMC) Approval
03/03/2015 PANCREAZE
BLA #022523		 SUPPL-8 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC Approval
03/03/2015 FORTAZ
NDA #050578		 SUPPL-60 CEFTAZIDIME PAI HOLDINGS PHARM Manufacturing (CMC) Approval
03/03/2015 IBUPROFEN
ANDA #074916		 SUPPL-50 IBUPROFEN P AND L Manufacturing (CMC) Approval
03/03/2015 LITHIUM CARBONATE
ANDA #079139		 SUPPL-2 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
03/03/2015 HEPARIN SODIUM
NDA #201370		 SUPPL-8 HEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
03/03/2015 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-8 HEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
03/03/2015 STENDRA
NDA #202276		 SUPPL-11 AVANAFIL METUCHEN PHARMS Manufacturing (CMC) Approval
03/03/2015 ZYTIGA
NDA #202379		 SUPPL-17 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
03/03/2015 INVOKANA
NDA #204042		 SUPPL-5 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
03/03/2015 ADRENALIN
NDA #204200		 SUPPL-3 EPINEPHRINE ENDO OPERATIONS Manufacturing (CMC) Approval
03/03/2015 MORPHINE SULFATE
NDA #204223		 SUPPL-4 MORPHINE SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/03/2015 INVOKAMET
NDA #204353		 SUPPL-2 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
03/03/2015 MIRVASO
NDA #204708		 SUPPL-2 BRIMONIDINE TARTRATE GALDERMA LABS LP Manufacturing (CMC) Approval
03/03/2015 OLYSIO
NDA #205123		 SUPPL-4 SIMEPREVIR SODIUM JANSSEN PRODS Manufacturing (CMC) Approval
03/04/2015 BIO-TROPIN
BLA #019774		 SUPPL-26 SOMATROPIN FERRING Approval
03/04/2015 ZOMACTON
BLA #019774		 SUPPL-26 SOMATROPIN FERRING Approval
03/04/2015 DORYX
NDA #050795		 SUPPL-20 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
03/04/2015 DORYX MPC
NDA #050795		 SUPPL-20 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
03/04/2015 ISOSORBIDE MONONITRATE
ANDA #075395		 SUPPL-25 ISOSORBIDE MONONITRATE ZYDUS HLTHCARE Labeling Approval
03/04/2015 OPDIVO
BLA #125527		 ORIG-1 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/04/2015 FENTANYL
ANDA #202577		 ORIG-1 FENTANYL MYLAN PHARMS INC Tentative Approval
03/04/2015 KALYDECO
NDA #203188		 SUPPL-17 IVACAFTOR VERTEX PHARMS Labeling Approval
03/04/2015 DISULFIRAM
ANDA #203916		 ORIG-1 DISULFIRAM DASH PHARMS Approval
03/04/2015 SIVEXTRO
NDA #205435		 SUPPL-1 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
03/04/2015 SIVEXTRO
NDA #205436		 SUPPL-1 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
03/05/2015 BYDUREON
NDA #022200		 SUPPL-14 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
03/05/2015 BYDUREON PEN
NDA #022200		 SUPPL-14 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
03/05/2015 DICYCLOMINE HYDROCHLORIDE
ANDA #040161		 SUPPL-9 DICYCLOMINE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
03/05/2015 OFLOXACIN
ANDA #076093		 SUPPL-5 OFLOXACIN CHARTWELL RX Manufacturing (CMC) Approval
03/05/2015 GABAPENTIN
ANDA #078787		 SUPPL-8 GABAPENTIN AUROBINDO PHARMA Manufacturing (CMC) Approval
03/05/2015 LANSOPRAZOLE
ANDA #090331		 SUPPL-7 LANSOPRAZOLE SANDOZ Manufacturing (CMC) Approval
03/05/2015 LANSOPRAZOLE
ANDA #090331		 SUPPL-14 LANSOPRAZOLE SANDOZ Labeling Approval
03/06/2015 RAPAMUNE
NDA #021083		 SUPPL-56 SIROLIMUS PF PRISM CV Labeling Approval
03/06/2015 RAPAMUNE
NDA #021110		 SUPPL-74 SIROLIMUS PF PRISM CV Labeling Approval
03/06/2015 OMEPRAZOLE
NDA #022032		 SUPPL-24 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
03/06/2015 DOXYLAMINE SUCCINATE
ANDA #040167		 SUPPL-43 DOXYLAMINE SUCCINATE PERRIGO Labeling Approval
03/06/2015 HYDRALAZINE HYDROCHLORIDE
ANDA #088468		 SUPPL-34 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
03/06/2015 ZOLEDRONIC ACID
ANDA #091186		 SUPPL-2 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
03/06/2015 ZOLEDRONIC ACID
ANDA #091186		 SUPPL-3 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
03/06/2015 ZOLEDRONIC ACID
ANDA #091186		 SUPPL-5 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
03/06/2015 ZARXIO
BLA #125553		 ORIG-1 FILGRASTIM-SNDZ SANDOZ INC Approval
03/06/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE NORVIUM BIOSCIENCE Approval
03/06/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202525		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE ADAPTIS Approval
03/06/2015 TECFIDERA
NDA #204063		 SUPPL-6 DIMETHYL FUMARATE BIOGEN INC Manufacturing (CMC) Approval
03/06/2015 CRESEMBA
NDA #207500		 ORIG-1 ISAVUCONAZONIUM SULFATE ASTELLAS Type 1 - New Molecular Entity Approval
03/06/2015 CRESEMBA
NDA #207501		 ORIG-1 ISAVUCONAZONIUM SULFATE ASTELLAS Type 3 - New Dosage Form Approval
03/09/2015 ROBAXIN
NDA #011011		 SUPPL-77 METHOCARBAMOL ENDO OPERATIONS Manufacturing (CMC) Approval
03/09/2015 ROBAXIN-750
NDA #011011		 SUPPL-77 METHOCARBAMOL ENDO OPERATIONS Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-134 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/2015 GALLIUM CITRATE GA 67
NDA #017478		 SUPPL-15 GALLIUM CITRATE GA-67 LANTHEUS MEDCL Manufacturing (CMC) Approval
03/09/2015 DILAUDID
NDA #019891		 SUPPL-20 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
03/09/2015 ADALAT CC
NDA #020198		 SUPPL-24 NIFEDIPINE NORWICH Manufacturing (CMC) Approval
03/09/2015 CEREZYME
BLA #020367		 SUPPL-92 IMIGLUCERASE GENZYME Approval
03/09/2015 PRECOSE
NDA #020482		 SUPPL-27 ACARBOSE BAYER HLTHCARE Labeling Approval
03/09/2015 INFASURF PRESERVATIVE FREE
BLA #020521		 SUPPL-28 CALFACTANT ONY Approval
03/09/2015 INFASURF PRESERVATIVE FREE
BLA #020521		 SUPPL-29 CALFACTANT ONY Approval
03/09/2015 EDEX
NDA #020649		 SUPPL-23 ALPROSTADIL ENDO OPERATIONS Labeling Approval
03/09/2015 QVAR 40
NDA #020911		 SUPPL-24 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/09/2015 QVAR 80
NDA #020911		 SUPPL-24 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/09/2015 KETEK
NDA #021144		 SUPPL-18 TELITHROMYCIN SANOFI AVENTIS US Labeling Approval
03/09/2015 MUCINEX
NDA #021282		 SUPPL-45 GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
03/09/2015 LOVAZA
NDA #021654		 SUPPL-42 OMEGA-3-ACID ETHYL ESTERS WOODWARD Manufacturing (CMC) Approval
03/09/2015 PLIAGLIS
NDA #021717		 SUPPL-7 LIDOCAINE; TETRACAINE CRESCITA THERAP Manufacturing (CMC) Approval
03/09/2015 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-7 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
03/09/2015 BYDUREON
NDA #022200		 SUPPL-19 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
03/09/2015 BYDUREON PEN
NDA #022200		 SUPPL-19 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
03/09/2015 VICTOZA
NDA #022341		 SUPPL-23 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
03/09/2015 CALDOLOR
NDA #022348		 SUPPL-4 IBUPROFEN CUMBERLAND PHARMS Manufacturing (CMC) Approval
03/09/2015 MINOCIN
NDA #050649		 SUPPL-25 MINOCYCLINE HYDROCHLORIDE BAUSCH Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071134		 SUPPL-28 DIAZEPAM DR REDDYS LABS SA Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071135		 SUPPL-31 DIAZEPAM DR REDDYS LABS SA Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071136		 SUPPL-32 DIAZEPAM DR REDDYS LABS SA Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071307		 SUPPL-31 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071321		 SUPPL-33 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
03/09/2015 DIAZEPAM
ANDA #071322		 SUPPL-33 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
03/09/2015 PINDOLOL
ANDA #074063		 SUPPL-17 PINDOLOL SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
03/09/2015 QUINAPRIL HYDROCHLORIDE
ANDA #076607		 SUPPL-9 QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
03/09/2015 QUINAPRIL HYDROCHLORIDE
ANDA #076607		 SUPPL-10 QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
03/09/2015 QUINAPRIL HYDROCHLORIDE
ANDA #076607		 SUPPL-11 QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
03/09/2015 QUINAPRIL HYDROCHLORIDE
ANDA #076607		 SUPPL-12 QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
03/09/2015 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-2 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/09/2015 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-3 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/09/2015 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-6 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/09/2015 CITALOPRAM HYDROBROMIDE
ANDA #077534		 SUPPL-9 CITALOPRAM HYDROBROMIDE INVAGEN PHARMS Labeling Approval
03/09/2015 CITALOPRAM HYDROBROMIDE
ANDA #077534		 SUPPL-10 CITALOPRAM HYDROBROMIDE INVAGEN PHARMS Labeling Approval
03/09/2015 ONDANSETRON HYDROCHLORIDE
ANDA #077577		 SUPPL-3 ONDANSETRON HYDROCHLORIDE WOCKHARDT Labeling Approval
03/09/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077716		 SUPPL-5 ONDANSETRON HYDROCHLORIDE WOCKHARDT Labeling Approval
03/09/2015 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-10 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
03/09/2015 AMIODARONE HYDROCHLORIDE
ANDA #079029		 SUPPL-13 AMIODARONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
03/09/2015 LOSARTAN POTASSIUM
ANDA #090790		 SUPPL-7 LOSARTAN POTASSIUM APOTEX CORP Labeling Approval
03/09/2015 LOSARTAN POTASSIUM
ANDA #090790		 SUPPL-8 LOSARTAN POTASSIUM APOTEX CORP Labeling Approval
03/09/2015 TANZEUM
BLA #125431		 SUPPL-8 ALBIGLUTIDE GLAXOSMITHKLINE LLC Approval
03/09/2015 TRULICITY
BLA #125469		 SUPPL-1 DULAGLUTIDE ELI LILLY AND CO Approval
03/09/2015 ELIQUIS
NDA #202155		 SUPPL-5 APIXABAN BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
03/09/2015 QNASL
NDA #202813		 SUPPL-4 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/09/2015 KALYDECO
NDA #203188		 SUPPL-10 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
03/09/2015 LEVOLEUCOVORIN CALCIUM
ANDA #203563		 ORIG-1 LEVOLEUCOVORIN CALCIUM SANDOZ Approval
03/10/2015 KEPPRA
NDA #021035		 SUPPL-93 LEVETIRACETAM UCB INC Labeling Approval
03/10/2015 ESTRASORB
NDA #021371		 SUPPL-7 ESTRADIOL HEMIHYDRATE EXELTIS USA INC Labeling Approval
03/10/2015 KEPPRA
NDA #021505		 SUPPL-33 LEVETIRACETAM UCB INC Labeling Approval
03/10/2015 KEPPRA
NDA #021872		 SUPPL-17 LEVETIRACETAM UCB INC Labeling Approval
03/10/2015 JANUVIA
NDA #021995		 SUPPL-32 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Manufacturing (CMC) Approval
03/10/2015 TREANDA
NDA #022249		 SUPPL-19 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
03/10/2015 KEPPRA XR
NDA #022285		 SUPPL-17 LEVETIRACETAM UCB INC Labeling Approval
03/10/2015 ELLA
NDA #022474		 SUPPL-7 ULIPRISTAL ACETATE LAB HRA PHARMA Labeling Approval
03/10/2015 REBIF
BLA #103780		 SUPPL-5172 INTERFERON BETA-1A SERONO INC Approval
03/10/2015 UNITUXIN
BLA #125516		 ORIG-1 DINUTUXIMAB UNITED THERAP Approval
03/11/2015 DOVONEX
NDA #020273		 SUPPL-13 CALCIPOTRIENE LEO PHARMA AS Labeling Approval
03/11/2015 DOVONEX
NDA #020554		 SUPPL-12 CALCIPOTRIENE LEO PHARMA AS Labeling Approval
03/11/2015 LIPITOR
NDA #020702		 SUPPL-65 ATORVASTATIN CALCIUM UPJOHN Labeling Approval
03/11/2015 ERBITUX
BLA #125084		 SUPPL-263 CETUXIMAB IMCLONE Approval
03/11/2015 VECTIBIX
BLA #125147		 SUPPL-200 PANITUMUMAB AMGEN Approval
03/11/2015 FARXIGA
NDA #202293		 SUPPL-2 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
03/12/2015 HUMULIN N
BLA #018781		 SUPPL-156 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/12/2015 HUMULIN 70/30
BLA #019717		 SUPPL-135 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/12/2015 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-135 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/12/2015 ZANTAC 150
NDA #021698		 SUPPL-18 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
03/12/2015 XOPENEX HFA
NDA #021730		 SUPPL-36 LEVALBUTEROL TARTRATE LUPIN Efficacy Approval
03/12/2015 SAPHRIS
NDA #022117		 SUPPL-17 ASENAPINE MALEATE ALLERGAN Labeling Approval
03/12/2015 SAPHRIS
NDA #022117		 SUPPL-18 ASENAPINE MALEATE ALLERGAN Efficacy Approval
03/12/2015 SAPHRIS
NDA #022117		 SUPPL-19 ASENAPINE MALEATE ALLERGAN Efficacy Approval
03/12/2015 AFREZZA
BLA #022472		 SUPPL-5 INSULIN RECOMBINANT HUMAN MANNKIND Approval
03/12/2015 NALOXONE
ANDA #070299		 SUPPL-17 NALOXONE HYDROCHLORIDE HIKMA Labeling Approval
03/12/2015 OFLOXACIN
ANDA #078559		 SUPPL-8 OFLOXACIN FDC LTD Manufacturing (CMC) Approval
03/12/2015 GUAIFENESIN
ANDA #078912		 SUPPL-1 GUAIFENESIN PERRIGO R AND D Manufacturing (CMC) Approval
03/12/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201524		 SUPPL-6 HYDROCHLOROTHIAZIDE; IRBESARTAN LUPIN LTD Labeling Approval
03/12/2015 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #201524		 SUPPL-6 IRBESARTAN; HYDROCHLOROTHIAZIDE LUPIN LTD Labeling Approval
03/12/2015 ZOLEDRONIC ACID
ANDA #202650		 SUPPL-2 ZOLEDRONIC ACID MYLAN LABS LTD Labeling Approval
03/12/2015 ZOLEDRONIC ACID
ANDA #202650		 SUPPL-5 ZOLEDRONIC ACID MYLAN LABS LTD Labeling Approval
03/12/2015 MONTELUKAST SODIUM
ANDA #203582		 ORIG-1 MONTELUKAST SODIUM MACLEODS PHARMS LTD Approval
03/12/2015 XARTEMIS XR
NDA #204031		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MALLINCKRODT INC Labeling Approval
03/13/2015 DEPAKENE
NDA #018081		 SUPPL-62 VALPROIC ACID ABBVIE Labeling Approval
03/13/2015 DEPAKENE
NDA #018082		 SUPPL-45 VALPROIC ACID ABBVIE Labeling Approval
03/13/2015 DEPAKOTE
NDA #018723		 SUPPL-54 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/13/2015 DEPAKOTE
NDA #019680		 SUPPL-41 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/13/2015 HUMALOG
BLA #020563		 SUPPL-124 INSULIN LISPRO RECOMBINANT LILLY Approval
03/13/2015 HUMALOG KWIKPEN
BLA #020563		 SUPPL-124 INSULIN LISPRO RECOMBINANT LILLY Approval
03/13/2015 HUMALOG PEN
BLA #020563		 SUPPL-124 INSULIN LISPRO RECOMBINANT LILLY Approval
03/13/2015 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-124 INSULIN LISPRO RECOMBINANT LILLY Approval
03/13/2015 DEPACON
NDA #020593		 SUPPL-32 VALPROATE SODIUM ABBVIE Labeling Approval
03/13/2015 DEPAKOTE ER
NDA #021168		 SUPPL-31 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/13/2015 NEXTERONE
NDA #022325		 SUPPL-9 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
03/13/2015 MINOXIDIL (FOR MEN)
ANDA #074588		 SUPPL-33 MINOXIDIL P AND L Labeling Approval
03/13/2015 VALACYCLOVIR HYDROCHLORIDE
ANDA #078518		 SUPPL-1 VALACYCLOVIR HYDROCHLORIDE MYLAN PHARMS INC Manufacturing (CMC) Approval
03/13/2015 DARIFENACIN HYDROBROMIDE
ANDA #091190		 ORIG-1 DARIFENACIN HYDROBROMIDE ENDO OPERATIONS Approval
03/13/2015 KEPIVANCE
BLA #125103		 SUPPL-167 PALIFERMIN BIOVITRUM AB Approval
03/14/2015 FLUCONAZOLE
ANDA #076658		 SUPPL-4 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #076658		 SUPPL-5 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #076658		 SUPPL-9 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #076665		 SUPPL-6 FLUCONAZOLE CHARTWELL Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #076665		 SUPPL-7 FLUCONAZOLE CHARTWELL Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #076665		 SUPPL-8 FLUCONAZOLE CHARTWELL Labeling Approval
03/14/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076766		 SUPPL-8 FLUCONAZOLE BAXTER HLTHCARE Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #077253		 SUPPL-8 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #077253		 SUPPL-9 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #077253		 SUPPL-11 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #078423		 SUPPL-1 FLUCONAZOLE ANI PHARMS Labeling Approval
03/14/2015 FLUCONAZOLE
ANDA #078423		 SUPPL-2 FLUCONAZOLE ANI PHARMS Labeling Approval
03/14/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #079104		 SUPPL-7 FLUCONAZOLE INFORLIFE Labeling Approval
03/14/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #079104		 SUPPL-8 FLUCONAZOLE INFORLIFE Labeling Approval
03/16/2015 MEPHYTON
NDA #010104		 SUPPL-30 PHYTONADIONE BAUSCH Manufacturing (CMC) Approval
03/16/2015 NORVIR
NDA #020659		 SUPPL-60 RITONAVIR ABBVIE Labeling Approval
03/16/2015 NORVIR
NDA #020945		 SUPPL-38 RITONAVIR ABBVIE Labeling Approval
03/16/2015 DEPOCYT
NDA #021041		 SUPPL-32 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
03/16/2015 TAMIFLU
NDA #021246		 SUPPL-50 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
03/16/2015 INVANZ
NDA #021337		 SUPPL-43 ERTAPENEM SODIUM MSD SUB MERCK Manufacturing (CMC) Approval
03/16/2015 CHLORHEXIDINE GLUCONATE
NDA #021669		 SUPPL-20 CHLORHEXIDINE GLUCONATE SAGE PRODS Manufacturing (CMC) Approval
03/16/2015 AVANDARYL
NDA #021700		 SUPPL-21 GLIMEPIRIDE; ROSIGLITAZONE MALEATE SB PHARMCO Labeling Approval
03/16/2015 DUETACT
NDA #021925		 SUPPL-15 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
03/16/2015 ACTOPLUS MET XR
NDA #022024		 SUPPL-11 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/16/2015 FERAHEME
NDA #022180		 SUPPL-11 FERUMOXYTOL COVIS Labeling Approval
03/16/2015 FERAHEME
NDA #022180		 SUPPL-13 FERUMOXYTOL COVIS Labeling Approval
03/16/2015 NORVIR
NDA #022417		 SUPPL-12 RITONAVIR ABBVIE Labeling Approval
03/16/2015 VIIBRYD
NDA #022567		 SUPPL-12 VILAZODONE HYDROCHLORIDE ABBVIE Efficacy Approval
03/16/2015 ZINACEF
NDA #050558		 SUPPL-73 CEFUROXIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
03/16/2015 AUGMENTIN ES-600
NDA #050755		 SUPPL-22 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
03/16/2015 AKTIPAK
NDA #050769		 SUPPL-16 BENZOYL PEROXIDE; ERYTHROMYCIN BIOFRONTERA Manufacturing (CMC) Approval
03/16/2015 GABAPENTIN
ANDA #075350		 SUPPL-54 GABAPENTIN ACTAVIS ELIZABETH Labeling Approval
03/16/2015 IBUPROFEN
ANDA #075682		 SUPPL-4 IBUPROFEN DR REDDYS Labeling Approval
03/16/2015 TRETINOIN
ANDA #076498		 SUPPL-10 TRETINOIN ZO SKIN HEALTH Labeling Approval
03/16/2015 ONDANSETRON
ANDA #076810		 SUPPL-4 ONDANSETRON TEVA Labeling Approval
03/16/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #077568		 SUPPL-6 CIPROFLOXACIN HYDROCHLORIDE FDC LTD Labeling Approval
03/16/2015 OMEPRAZOLE
ANDA #078490		 SUPPL-4 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/16/2015 OMEPRAZOLE
ANDA #078490		 SUPPL-5 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/16/2015 OMEPRAZOLE
ANDA #078490		 SUPPL-6 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-6 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-7 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-6 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-7 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079103		 SUPPL-4 MONTELUKAST SODIUM NORVIUM BIOSCIENCE Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079103		 SUPPL-5 MONTELUKAST SODIUM NORVIUM BIOSCIENCE Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079103		 SUPPL-8 MONTELUKAST SODIUM NORVIUM BIOSCIENCE Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079142		 SUPPL-4 MONTELUKAST SODIUM NATCO PHARMA Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079142		 SUPPL-5 MONTELUKAST SODIUM NATCO PHARMA Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #079142		 SUPPL-8 MONTELUKAST SODIUM NATCO PHARMA Labeling Approval
03/16/2015 LANSOPRAZOLE
ANDA #090763		 SUPPL-8 LANSOPRAZOLE MYLAN PHARMS INC Labeling Approval
03/16/2015 SILDENAFIL CITRATE
ANDA #091379		 SUPPL-2 SILDENAFIL CITRATE APOTEX CORP Labeling Approval
03/16/2015 YERVOY
BLA #125377		 SUPPL-71 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
03/16/2015 CONTRAVE
NDA #200063		 SUPPL-1 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Manufacturing (CMC) Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #201294		 SUPPL-5 MONTELUKAST SODIUM APOTEX CORP Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #201294		 SUPPL-6 MONTELUKAST SODIUM APOTEX CORP Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #201508		 SUPPL-5 MONTELUKAST SODIUM APOTEX INC Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #201508		 SUPPL-7 MONTELUKAST SODIUM APOTEX INC Labeling Approval
03/16/2015 LANSOPRAZOLE
ANDA #201921		 SUPPL-1 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
03/16/2015 ZECUITY
NDA #202278		 SUPPL-3 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/16/2015 LANSOPRAZOLE
ANDA #202366		 SUPPL-2 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
03/16/2015 SILDENAFIL CITRATE
ANDA #202503		 SUPPL-2 SILDENAFIL CITRATE WATSON LABS INC Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #202717		 SUPPL-5 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #202717		 SUPPL-7 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
03/16/2015 MONTELUKAST SODIUM
ANDA #202717		 SUPPL-9 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
03/16/2015 FLUOXETINE HYDROCHLORIDE
ANDA #204597		 ORIG-1 FLUOXETINE HYDROCHLORIDE SCIEGEN PHARMS INC Approval
03/17/2015 TIMOLOL MALEATE
ANDA #075412		 SUPPL-21 TIMOLOL MALEATE APOTEX INC Labeling Approval
03/17/2015 LABETALOL HYDROCHLORIDE
ANDA #079134		 SUPPL-6 LABETALOL HYDROCHLORIDE STERISCIENCE SPECLTS Labeling Approval
03/17/2015 PERJETA
BLA #125409		 SUPPL-104 PERTUZUMAB GENENTECH Approval
03/17/2015 SIGNIFOR
NDA #200677		 SUPPL-2 PASIREOTIDE DIASPARTATE RECORDATI RARE Labeling Approval
03/17/2015 RISPERIDONE
ANDA #201003		 SUPPL-6 RISPERIDONE AJANTA PHARMA LTD Manufacturing (CMC) Approval
03/17/2015 LANSOPRAZOLE
ANDA #202637		 SUPPL-5 LANSOPRAZOLE SUN PHARM Labeling Approval
03/17/2015 CHOLBAM
NDA #205750		 ORIG-1 CHOLIC ACID MIRUM Type 1 - New Molecular Entity Approval
03/17/2015 KALYDECO
NDA #207925		 ORIG-1 IVACAFTOR VERTEX PHARMS INC Type 3 - New Dosage Form Approval
03/18/2015 DIDRONEL
NDA #017831		 SUPPL-57 ETIDRONATE DISODIUM APIL Labeling Approval
03/18/2015 IMODIUM A-D
NDA #019487		 SUPPL-27 LOPERAMIDE HYDROCHLORIDE KENVUE BRANDS Labeling Approval
03/18/2015 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-20 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE KENVUE BRANDS Labeling Approval
03/18/2015 BONIVA
NDA #021455		 SUPPL-19 IBANDRONATE SODIUM HOFFMANN LA ROCHE Labeling Approval
03/18/2015 BONIVA
NDA #021858		 SUPPL-19 IBANDRONATE SODIUM ROCHE Labeling Approval
03/18/2015 INTUNIV
NDA #022037		 SUPPL-11 GUANFACINE HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
03/18/2015 CEFOBID
NDA #050551		 SUPPL-43 CEFOPERAZONE SODIUM PFIZER Labeling Approval
03/18/2015 HALOPERIDOL
ANDA #071233		 SUPPL-16 HALOPERIDOL VINTAGE Labeling Approval
03/18/2015 HALOPERIDOL
ANDA #071234		 SUPPL-15 HALOPERIDOL VINTAGE Labeling Approval
03/18/2015 HALOPERIDOL
ANDA #071235		 SUPPL-15 HALOPERIDOL STRIDES PHARMA Labeling Approval
03/18/2015 HALOPERIDOL
ANDA #071236		 SUPPL-15 HALOPERIDOL VINTAGE Labeling Approval
03/18/2015 HALOPERIDOL
ANDA #071237		 SUPPL-15 HALOPERIDOL VINTAGE Labeling Approval
03/18/2015 FLUCONAZOLE
ANDA #076077		 SUPPL-10 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
03/18/2015 FLUCONAZOLE
ANDA #076077		 SUPPL-11 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
03/18/2015 IBUPROFEN
ANDA #076117		 SUPPL-5 IBUPROFEN DR REDDYS LABS INC Labeling Approval
03/18/2015 METOPROLOL TARTRATE
ANDA #076704		 SUPPL-21 METOPROLOL TARTRATE MYLAN Manufacturing (CMC) Approval
03/18/2015 MIRTAZAPINE
ANDA #076901		 SUPPL-12 MIRTAZAPINE IMPAX LABS INC Manufacturing (CMC) Approval
03/18/2015 ONDANSETRON HYDROCHLORIDE
ANDA #076930		 SUPPL-7 ONDANSETRON HYDROCHLORIDE RISING Labeling Approval
03/18/2015 HYDROCHLOROTHIAZIDE
ANDA #077005		 SUPPL-8 HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS Manufacturing (CMC) Approval
03/18/2015 ONDANSETRON HYDROCHLORIDE
ANDA #077050		 SUPPL-7 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
03/18/2015 TRIMIPRAMINE MALEATE
ANDA #077361		 SUPPL-4 TRIMIPRAMINE MALEATE ELITE LABS INC Manufacturing (CMC) Approval
03/18/2015 TRIMIPRAMINE MALEATE
ANDA #077361		 SUPPL-5 TRIMIPRAMINE MALEATE ELITE LABS INC Manufacturing (CMC) Approval
03/18/2015 TRIMIPRAMINE MALEATE
ANDA #077361		 SUPPL-6 TRIMIPRAMINE MALEATE ELITE LABS INC Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077560		 SUPPL-8 ZIPRASIDONE HYDROCHLORIDE LUPIN PHARMS Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-3 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-6 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077562		 SUPPL-7 ZIPRASIDONE HYDROCHLORIDE SANDOZ INC Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077562		 SUPPL-9 ZIPRASIDONE HYDROCHLORIDE SANDOZ INC Labeling Approval
03/18/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077562		 SUPPL-10 ZIPRASIDONE HYDROCHLORIDE SANDOZ INC Labeling Approval
03/18/2015 FOMEPIZOLE
ANDA #078537		 SUPPL-2 FOMEPIZOLE NAVINTA LLC Labeling Approval
03/18/2015 LANSOPRAZOLE
ANDA #091212		 SUPPL-1 LANSOPRAZOLE KRKA TOVARNA ZDRAVIL Labeling Approval
03/18/2015 TENOFOVIR DISOPROXIL FUMARATE
ANDA #091612		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Approval
03/18/2015 PEGASYS
BLA #103964		 SUPPL-5264 PEGINTERFERON ALFA-2A zr pharma& Approval
03/18/2015 SILDENAFIL CITRATE
ANDA #202025		 SUPPL-1 SILDENAFIL CITRATE AMNEAL PHARMS Labeling Approval
03/19/2015 CIPRO
NDA #019847		 SUPPL-56 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/19/2015 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-64 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/19/2015 COARTEM
NDA #022268		 SUPPL-12 ARTEMETHER; LUMEFANTRINE NOVARTIS Labeling Approval
03/19/2015 BACTROBAN
NDA #050591		 SUPPL-30 MUPIROCIN GLAXOSMITHKLINE Labeling Approval
03/19/2015 BACTROBAN
NDA #050746		 SUPPL-13 MUPIROCIN CALCIUM GLAXOSMITHKLINE Labeling Approval
03/19/2015 AZITHROMYCIN
ANDA #065419		 SUPPL-12 AZITHROMYCIN TEVA PHARMS Labeling Approval
03/19/2015 AZITHROMYCIN
ANDA #065500		 SUPPL-3 AZITHROMYCIN HOSPIRA Labeling Approval
03/19/2015 AZITHROMYCIN
ANDA #065500		 SUPPL-5 AZITHROMYCIN HOSPIRA Labeling Approval
03/19/2015 AZITHROMYCIN
ANDA #065501		 SUPPL-4 AZITHROMYCIN GLAND PHARMA LTD Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076246		 SUPPL-10 FLUCONAZOLE HIKMA Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076246		 SUPPL-11 FLUCONAZOLE HIKMA Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076246		 SUPPL-12 FLUCONAZOLE HIKMA Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #076410		 SUPPL-14 ZOLPIDEM TARTRATE TEVA Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076507		 SUPPL-5 FLUCONAZOLE TARO Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076507		 SUPPL-6 FLUCONAZOLE TARO Labeling Approval
03/19/2015 FLUCONAZOLE
ANDA #076507		 SUPPL-7 FLUCONAZOLE TARO Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #076578		 SUPPL-12 ZOLPIDEM TARTRATE RISING Labeling Approval
03/19/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
ANDA #076736		 SUPPL-13 FLUCONAZOLE HIKMA FARMACEUTICA Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-14 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #078148		 SUPPL-9 ZOLPIDEM TARTRATE ENDO OPERATIONS Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-11 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
03/19/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #078698		 SUPPL-4 FLUCONAZOLE HIKMA FARMACEUTICA Labeling Approval
03/19/2015 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078764		 SUPPL-4 FLUCONAZOLE HIKMA FARMACEUTICA Labeling Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #078970		 SUPPL-2 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
03/19/2015 TRIFLUOPERAZINE HYDROCHLORIDE
ANDA #085787		 SUPPL-31 TRIFLUOPERAZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/19/2015 FINASTERIDE
ANDA #090061		 SUPPL-10 FINASTERIDE HETERO LABS LTD III Manufacturing (CMC) Approval
03/19/2015 LEVOFLOXACIN
ANDA #090367		 SUPPL-3 LEVOFLOXACIN ANDA REPOSITORY Labeling Approval
03/19/2015 ZOLEDRONIC ACID
ANDA #090621		 ORIG-1 ZOLEDRONIC ACID HOSPIRA Approval
03/19/2015 AZITHROMYCIN
ANDA #090923		 SUPPL-2 AZITHROMYCIN SUN PHARM INDS LTD Labeling Approval
03/19/2015 ESZOPICLONE
ANDA #091124		 SUPPL-1 ESZOPICLONE LUPIN LTD Labeling Approval
03/19/2015 ESZOPICLONE
ANDA #091124		 SUPPL-2 ESZOPICLONE LUPIN LTD Labeling Approval
03/19/2015 YERVOY
BLA #125377		 SUPPL-72 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
03/19/2015 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-1 ZOLPIDEM TARTRATE APOTEX Labeling Approval
03/20/2015 XELODA
NDA #020896		 SUPPL-37 CAPECITABINE CHEPLAPHARM Labeling Approval
03/20/2015 CENESTIN
NDA #020992		 SUPPL-34 ESTROGENS, CONJUGATED SYNTHETIC A ASPEN Labeling Approval
03/20/2015 DEPAKOTE ER
NDA #021168		 SUPPL-30 DIVALPROEX SODIUM ABBVIE Labeling Approval
03/20/2015 SYMLIN
NDA #021332		 SUPPL-25 PRAMLINTIDE ACETATE ASTRAZENECA AB Labeling Approval
03/20/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #040300		 SUPPL-15 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/20/2015 PHENYTOIN
ANDA #040521		 SUPPL-7 PHENYTOIN TARO Labeling Approval
03/20/2015 ROCEPHIN
NDA #050585		 SUPPL-66 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
03/20/2015 ROCEPHIN KIT
NDA #050585		 SUPPL-66 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065150		 SUPPL-12 AZITHROMYCIN TEVA Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065150		 SUPPL-13 AZITHROMYCIN TEVA Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065223		 SUPPL-20 AZITHROMYCIN PLIVA Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065225		 SUPPL-24 AZITHROMYCIN PLIVA Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065302		 SUPPL-3 AZITHROMYCIN CHARTWELL RX Labeling Approval
03/20/2015 AZITHROMYCIN
ANDA #065508		 SUPPL-2 AZITHROMYCIN APOTEX CORP Labeling Approval
03/20/2015 TERAZOSIN HYDROCHLORIDE
ANDA #075317		 SUPPL-11 TERAZOSIN HYDROCHLORIDE JUBILANT CADISTA Manufacturing (CMC) Approval
03/20/2015 OMEPRAZOLE
ANDA #075576		 SUPPL-15 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/20/2015 METHYLIN ER
ANDA #075629		 SUPPL-12 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/20/2015 OMEPRAZOLE
ANDA #075876		 SUPPL-33 OMEPRAZOLE STRIDES PHARMA Labeling Approval
03/20/2015 OMEPRAZOLE
ANDA #075876		 SUPPL-36 OMEPRAZOLE STRIDES PHARMA Labeling Approval
03/20/2015 OMEPRAZOLE
ANDA #075876		 SUPPL-37 OMEPRAZOLE STRIDES PHARMA Labeling Approval
03/20/2015 OMEPRAZOLE
ANDA #076048		 SUPPL-19 OMEPRAZOLE APOTEX Labeling Approval
03/20/2015 OFLOXACIN
ANDA #076093		 SUPPL-7 OFLOXACIN CHARTWELL RX Labeling Approval
03/20/2015 CYCLAFEM 7/7/7
ANDA #076338		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ENDO OPERATIONS Labeling Approval
03/20/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE DR REDDYS Labeling Approval
03/20/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #077437		 SUPPL-3 MOXIFLOXACIN HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
03/20/2015 ATENOLOL
ANDA #077877		 SUPPL-3 ATENOLOL IPCA LABS LTD Labeling Approval
03/20/2015 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-43 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
03/20/2015 MOLINDONE HYDROCHLORIDE
ANDA #090453		 ORIG-1 MOLINDONE HYDROCHLORIDE EPIC PHARMA LLC Approval
03/20/2015 ENBREL
BLA #103795		 SUPPL-5532 ETANERCEPT IMMUNEX Approval
03/20/2015 ZYTIGA
NDA #202379		 SUPPL-16 ABIRATERONE ACETATE JANSSEN BIOTECH Efficacy Approval
03/20/2015 XALKORI
NDA #202570		 SUPPL-13 CRIZOTINIB PF PRISM CV Labeling Approval
03/20/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #202859		 SUPPL-1 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #202859		 SUPPL-3 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #202859		 SUPPL-4 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #203037		 SUPPL-1 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #203037		 SUPPL-3 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 MONTELUKAST SODIUM
ANDA #203037		 SUPPL-4 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Labeling Approval
03/20/2015 SOVALDI
NDA #204671		 SUPPL-4 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/20/2015 ARNUITY ELLIPTA
NDA #205625		 SUPPL-1 FLUTICASONE FUROATE GLAXOSMITHKLINE Labeling Approval
03/20/2015 HARVONI
NDA #205834		 SUPPL-1 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/23/2015 NORVASC
NDA #019787		 SUPPL-59 AMLODIPINE BESYLATE VIATRIS Labeling Approval
03/23/2015 EPIVIR
NDA #020564		 SUPPL-33 LAMIVUDINE VIIV HLTHCARE Efficacy Approval
03/23/2015 EPIVIR
NDA #020596		 SUPPL-32 LAMIVUDINE VIIV HLTHCARE Efficacy Approval
03/23/2015 RHINOCORT
NDA #020746		 SUPPL-32 BUDESONIDE KENVUE BRANDS Efficacy Approval
03/23/2015 RHINOCORT ALLERGY
NDA #020746		 SUPPL-32 BUDESONIDE KENVUE BRANDS Efficacy Approval
03/23/2015 ZIAGEN
NDA #020977		 SUPPL-27 ABACAVIR SULFATE VIIV HLTHCARE Efficacy Approval
03/23/2015 ZIAGEN
NDA #020978		 SUPPL-31 ABACAVIR SULFATE VIIV HLTHCARE Efficacy Approval
03/23/2015 CARDIZEM LA
NDA #021392		 SUPPL-19 DILTIAZEM HYDROCHLORIDE BAUSCH Labeling Approval
03/23/2015 CADUET
NDA #021540		 SUPPL-36 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
03/23/2015 CLAFORAN
NDA #050547		 SUPPL-71 CEFOTAXIME SODIUM STERIMAX Labeling Approval
03/23/2015 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-42 CEFOTAXIME SODIUM STERIMAX Labeling Approval
03/23/2015 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-42 CEFOTAXIME SODIUM STERIMAX Labeling Approval
03/23/2015 ARGATROBAN
NDA #201811		 ORIG-1 ARGATROBAN FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
03/24/2015 ACTHAR GEL
NDA #008372		 SUPPL-44 CORTICOTROPIN MALLINCKRODT IRELAND Labeling Approval
03/24/2015 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-44 CORTICOTROPIN MALLINCKRODT IRELAND Labeling Approval
03/24/2015 LAMICTAL
NDA #020241		 SUPPL-45 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL
NDA #020241		 SUPPL-51 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL CD
NDA #020764		 SUPPL-38 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL CD
NDA #020764		 SUPPL-44 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL XR
NDA #022115		 SUPPL-11 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL XR
NDA #022115		 SUPPL-18 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL ODT
NDA #022251		 SUPPL-7 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LAMICTAL ODT
NDA #022251		 SUPPL-14 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
03/24/2015 LIDOCAINE HYDROCHLORIDE
ANDA #040014		 SUPPL-4 LIDOCAINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
03/24/2015 MICONAZOLE 7
ANDA #074164		 SUPPL-22 MICONAZOLE NITRATE P AND L Labeling Approval
03/24/2015 MICONAZOLE 7
ANDA #074164		 SUPPL-25 MICONAZOLE NITRATE P AND L Labeling Approval
03/24/2015 ACETYLCYSTEINE
ANDA #203173		 ORIG-1 ACETYLCYSTEINE RISING Approval
03/25/2015 VIMOVO
NDA #022511		 SUPPL-15 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
03/25/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-3 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
03/25/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-7 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
03/25/2015 ZOLEDRONIC ACID
ANDA #091170		 SUPPL-2 ZOLEDRONIC ACID BRECKENRIDGE Labeling Approval
03/25/2015 ZOLEDRONIC ACID
ANDA #091170		 SUPPL-4 ZOLEDRONIC ACID BRECKENRIDGE Labeling Approval
03/25/2015 ENBREL
BLA #103795		 SUPPL-5548 ETANERCEPT IMMUNEX Approval
03/25/2015 EYLEA
BLA #125387		 SUPPL-48 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
03/25/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-3 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
03/26/2015 ACTONEL
NDA #020835		 SUPPL-47 RISEDRONATE SODIUM APIL Labeling Approval
03/26/2015 VIAGRA
NDA #020895		 SUPPL-44 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/26/2015 ACTONEL WITH CALCIUM (COPACKAGED)
NDA #021823		 SUPPL-10 CALCIUM CARBONATE; RISEDRONATE SODIUM WARNER CHILCOTT Labeling Approval
03/26/2015 BRILINTA
NDA #022433		 SUPPL-13 TICAGRELOR ASTRAZENECA Labeling Approval
03/26/2015 ATELVIA
NDA #022560		 SUPPL-6 RISEDRONATE SODIUM APIL Labeling Approval
03/26/2015 TOLCAPONE
ANDA #204584		 ORIG-1 TOLCAPONE ENDO OPERATIONS Approval
03/26/2015 ORALTAG
NDA #205383		 ORIG-1 IOHEXOL INTERPHARMA PRAHA AS Type 3 - New Dosage Form Approval
03/27/2015 CORDARONE
NDA #018972		 SUPPL-47 AMIODARONE HYDROCHLORIDE WYETH PHARMS Labeling Approval
03/27/2015 INVIRASE
NDA #020628		 SUPPL-42 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Labeling Approval
03/27/2015 NORVIR
NDA #020659		 SUPPL-61 RITONAVIR ABBVIE Labeling Approval
03/27/2015 MIRAPEX
NDA #020667		 SUPPL-30 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/27/2015 CRIXIVAN
NDA #020685		 SUPPL-77 INDINAVIR SULFATE MERCK SHARP DOHME Labeling Approval
03/27/2015 VIRACEPT
NDA #020778		 SUPPL-40 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
03/27/2015 VIRACEPT
NDA #020779		 SUPPL-61 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
03/27/2015 NORVIR
NDA #020945		 SUPPL-39 RITONAVIR ABBVIE Labeling Approval
03/27/2015 SUSTIVA
NDA #020972		 SUPPL-48 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
03/27/2015 KALETRA
NDA #021226		 SUPPL-41 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
03/27/2015 KALETRA
NDA #021251		 SUPPL-50 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
03/27/2015 EMSAM
NDA #021336		 SUPPL-11 SELEGILINE SOMERSET Labeling Approval
03/27/2015 SUSTIVA
NDA #021360		 SUPPL-37 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
03/27/2015 VIRACEPT
NDA #021503		 SUPPL-23 NELFINAVIR MESYLATE AGOURON PHARMS Labeling Approval
03/27/2015 LEXIVA
NDA #021548		 SUPPL-36 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/27/2015 REYATAZ
NDA #021567		 SUPPL-37 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
03/27/2015 INVIRASE
NDA #021785		 SUPPL-18 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
03/27/2015 APTIVUS
NDA #021814		 SUPPL-15 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
03/27/2015 KALETRA
NDA #021906		 SUPPL-43 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
03/27/2015 PREZISTA
NDA #021976		 SUPPL-39 DARUNAVIR JANSSEN PRODS Labeling Approval
03/27/2015 TEKTURNA
NDA #021985		 SUPPL-27 ALISKIREN HEMIFUMARATE NODEN PHARMA Labeling Approval
03/27/2015 EOVIST
NDA #022090		 SUPPL-11 GADOXETATE DISODIUM BAYER HLTHCARE Efficacy Approval
03/27/2015 TEKTURNA HCT
NDA #022107		 SUPPL-25 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE NODEN PHARMA Labeling Approval
03/27/2015 LEXIVA
NDA #022116		 SUPPL-20 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/27/2015 APTIVUS
NDA #022292		 SUPPL-8 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
03/27/2015 NORVIR
NDA #022417		 SUPPL-13 RITONAVIR ABBVIE Labeling Approval
03/27/2015 MIRAPEX ER
NDA #022421		 SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/27/2015 TEKAMLO
NDA #022545		 SUPPL-16 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE NOVARTIS Labeling Approval
03/27/2015 AMTURNIDE
NDA #200045		 SUPPL-16 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
03/27/2015 KYPROLIS
NDA #202714		 SUPPL-8 CARFILZOMIB ONYX PHARMS AMGEN Labeling Approval
03/27/2015 PREZISTA
NDA #202895		 SUPPL-16 DARUNAVIR JANSSEN PRODS Labeling Approval
03/27/2015 LACTULOSE
ANDA #203762		 ORIG-1 LACTULOSE APOZEAL PHARMS Approval
03/27/2015 SAXENDA
NDA #206321		 SUPPL-1 LIRAGLUTIDE NOVO Labeling Approval
03/27/2015 REYATAZ
NDA #206352		 SUPPL-2 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
03/29/2015 RITONAVIR
NDA #205040		 ORIG-1 RITONAVIR CIPLA LIMITED Type 5 - New Formulation or New Manufacturer Tentative Approval
03/30/2015 EDECRIN
NDA #016092		 SUPPL-46 ETHACRYNIC ACID BAUSCH Manufacturing (CMC) Approval
03/30/2015 UREX
NDA #016151		 SUPPL-28 METHENAMINE HIPPURATE ALVOGEN Manufacturing (CMC) Approval
03/30/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016733		 SUPPL-54 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
03/30/2015 STERILE WATER IN PLASTIC CONTAINER
NDA #016734		 SUPPL-49 STERILE WATER FOR IRRIGATION B BRAUN Manufacturing (CMC) Approval
03/30/2015 ZAROXOLYN
NDA #017386		 SUPPL-40 METOLAZONE I3 PHARMS Manufacturing (CMC) Approval
03/30/2015 CESAMET
NDA #018677		 SUPPL-15 NABILONE BAUSCH Manufacturing (CMC) Approval
03/30/2015 ESTROSTEP 21
NDA #020130		 SUPPL-13 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
03/30/2015 ESTROSTEP FE
NDA #020130		 SUPPL-13 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
03/30/2015 ACEON
NDA #020184		 SUPPL-22 PERINDOPRIL ERBUMINE SYMPLMED PHARMS LLC Labeling Approval
03/30/2015 SOLARAZE
NDA #021005		 SUPPL-15 DICLOFENAC SODIUM FOUGERA PHARMS Manufacturing (CMC) Approval
03/30/2015 RAPAMUNE
NDA #021110		 SUPPL-72 SIROLIMUS PF PRISM CV Manufacturing (CMC) Approval
03/30/2015 RETISERT
NDA #021737		 SUPPL-22 FLUOCINOLONE ACETONIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
03/30/2015 SALONPAS
NDA #022029		 SUPPL-10 MENTHOL; METHYL SALICYLATE HISAMITSU PHARM CO Manufacturing (CMC) Approval
03/30/2015 OMEPRAZOLE
NDA #022032		 SUPPL-27 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
03/30/2015 FANAPT
NDA #022192		 SUPPL-14 ILOPERIDONE VANDA PHARMS INC Manufacturing (CMC) Approval
03/30/2015 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-6 TOPOTECAN HYDROCHLORIDE MEITHEAL Manufacturing (CMC) Approval
03/30/2015 PANCREAZE
BLA #022523		 SUPPL-9 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC Approval
03/30/2015 ADVIL CONGESTION RELIEF
NDA #022565		 SUPPL-2 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
03/30/2015 BETAMETHASONE DIPROPIONATE
ANDA #071012		 SUPPL-21 BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC Manufacturing (CMC) Approval
03/30/2015 DESIPRAMINE HYDROCHLORIDE
ANDA #072103		 SUPPL-26 DESIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/30/2015 DESIPRAMINE HYDROCHLORIDE
ANDA #072103		 SUPPL-27 DESIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/30/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090245		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN LUPIN Approval
03/30/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090483		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN MYLAN Approval
03/30/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #091235		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN TEVA PHARMS USA Approval
03/30/2015 NEUPOGEN
BLA #103353		 SUPPL-5183 FILGRASTIM AMGEN Approval
03/30/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202377		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN TORRENT Approval
03/30/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202829		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN NOVEL LABS INC Approval
03/30/2015 CHOLINE C-11
NDA #203155		 SUPPL-4 CHOLINE C-11 MCPRF Manufacturing (CMC) Approval
03/30/2015 QUDEXY XR
NDA #205122		 SUPPL-1 TOPIRAMATE UPSHER SMITH LABS Efficacy Approval
03/30/2015 JADENU
NDA #206910		 ORIG-1 DEFERASIROX NOVARTIS PHARMS CORP Type 5 - New Formulation or New Manufacturer Approval
03/31/2015 XOPENEX
NDA #020837		 SUPPL-43 LEVALBUTEROL HYDROCHLORIDE HIKMA Labeling Approval
03/31/2015 TYKERB
NDA #022059		 SUPPL-20 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
03/31/2015 SANDIMMUNE
NDA #050573		 SUPPL-41 CYCLOSPORINE NOVARTIS Labeling Approval
03/31/2015 SANDIMMUNE
NDA #050574		 SUPPL-51 CYCLOSPORINE NOVARTIS Labeling Approval
03/31/2015 SANDIMMUNE
NDA #050625		 SUPPL-55 CYCLOSPORINE NOVARTIS Labeling Approval
03/31/2015 NEORAL
NDA #050715		 SUPPL-35 CYCLOSPORINE NOVARTIS Labeling Approval
03/31/2015 NEORAL
NDA #050716		 SUPPL-38 CYCLOSPORINE NOVARTIS Labeling Approval
03/31/2015 GABAPENTIN
ANDA #200651		 SUPPL-5 GABAPENTIN AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
03/31/2015 LOSARTAN POTASSIUM
ANDA #201170		 SUPPL-2 LOSARTAN POTASSIUM JUBILANT CADISTA Manufacturing (CMC) Approval
03/31/2015 ZOLEDRONIC ACID
ANDA #201783		 SUPPL-3 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
03/31/2015 ZOLEDRONIC ACID
ANDA #201783		 SUPPL-4 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
03/31/2015 ZOLEDRONIC ACID
ANDA #201783		 SUPPL-7 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
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NDA #205636		 ORIG-1 ALBUTEROL SULFATE TEVA BRANDED PHARM Type 3 - New Dosage Form Approval
03/31/2015 PROAIR RESPICLICK
NDA #205636		 ORIG-1 ALBUTEROL SULFATE TEVA BRANDED PHARM Type 3 - New Dosage Form Approval
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