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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 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 April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2015 TUSSIONEX PENNKINETIC
NDA #019111		 SUPPL-18 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX UCB INC Labeling Approval
04/01/2015 ARTHROTEC
NDA #020607		 SUPPL-21 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
04/01/2015 VOTRIENT
NDA #022465		 SUPPL-20 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
04/01/2015 OMEPRAZOLE
ANDA #075347		 SUPPL-18 OMEPRAZOLE ACTAVIS LABS FL INC Labeling Approval
04/01/2015 OMEPRAZOLE
ANDA #075347		 SUPPL-20 OMEPRAZOLE ACTAVIS LABS FL INC Labeling Approval
04/01/2015 DIAZEPAM
ANDA #077749		 SUPPL-6 DIAZEPAM STRIDES PHARMA Labeling Approval
04/01/2015 ENSKYCE
ANDA #201887		 SUPPL-2 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
04/01/2015 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202086		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE MYLAN LABS LTD Approval
04/01/2015 SILDENAFIL CITRATE
ANDA #203988		 ORIG-1 SILDENAFIL CITRATE EUGIA PHARMA Approval
04/02/2015 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-38 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
04/02/2015 BIDIL
NDA #020727		 SUPPL-5 HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE AZURITY Labeling Approval
04/02/2015 TEMODAR
NDA #021029		 SUPPL-28 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
04/02/2015 TEMODAR
NDA #022277		 SUPPL-8 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
04/02/2015 ADCIRCA
NDA #022332		 SUPPL-7 TADALAFIL ELI LILLY CO Labeling Approval
04/02/2015 LIDOCAINE HYDROCHLORIDE
ANDA #040014		 SUPPL-6 LIDOCAINE HYDROCHLORIDE HIKMA Labeling Approval
04/02/2015 ACEPHEN
ANDA #072344		 SUPPL-9 ACETAMINOPHEN COSETTE Labeling Approval
04/02/2015 DESMOPRESSIN ACETATE
ANDA #074830		 SUPPL-15 DESMOPRESSIN ACETATE BAUSCH Labeling Approval
04/02/2015 MOEXIPRIL HYDROCHLORIDE
ANDA #076204		 SUPPL-12 MOEXIPRIL HYDROCHLORIDE TEVA Labeling Approval
04/02/2015 MOEXIPRIL HYDROCHLORIDE
ANDA #076204		 SUPPL-13 MOEXIPRIL HYDROCHLORIDE TEVA Labeling Approval
04/02/2015 ERRIN
ANDA #076225		 SUPPL-11 NORETHINDRONE DR REDDYS LABS SA Labeling Approval
04/02/2015 LANSOPRAZOLE
ANDA #077255		 SUPPL-14 LANSOPRAZOLE TEVA PHARMS Labeling Approval
04/02/2015 ZOLPIDEM TARTRATE
ANDA #078616		 SUPPL-9 ZOLPIDEM TARTRATE STRIDES PHARMA Labeling Approval
04/02/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #078833		 SUPPL-2 DROSPIRENONE; ETHINYL ESTRADIOL WATSON LABS Labeling Approval
04/02/2015 GEMCITABINE HYDROCHLORIDE
ANDA #079160		 SUPPL-6 GEMCITABINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
04/02/2015 LETROZOLE
ANDA #090789		 SUPPL-1 LETROZOLE STRIDES PHARMA Labeling Approval
04/02/2015 LETROZOLE
ANDA #090789		 SUPPL-3 LETROZOLE STRIDES PHARMA Labeling Approval
04/02/2015 JENCYCLA
ANDA #091323		 SUPPL-2 NORETHINDRONE LUPIN LTD Labeling Approval
04/02/2015 NAPROXEN SODIUM
ANDA #200629		 SUPPL-3 NAPROXEN SODIUM AUROBINDO PHARMA LTD Labeling Approval
04/02/2015 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-4 RABEPRAZOLE SODIUM TORRENT Labeling Approval
04/02/2015 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-5 RABEPRAZOLE SODIUM TORRENT Labeling Approval
04/02/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #202395		 SUPPL-1 ZIPRASIDONE HYDROCHLORIDE MYLAN Labeling Approval
04/02/2015 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #203038		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS LTD Approval
04/02/2015 ONDANSETRON HYDROCHLORIDE
ANDA #203761		 SUPPL-1 ONDANSETRON HYDROCHLORIDE IPCA LABS LTD Labeling Approval
04/02/2015 SILDENAFIL CITRATE
ANDA #203814		 SUPPL-1 SILDENAFIL CITRATE MACLEODS PHARMS LTD Labeling Approval
04/03/2015 FINACEA
NDA #021470		 SUPPL-10 AZELAIC ACID LEO PHARMA AS Labeling Approval
04/03/2015 NALLPEN IN PLASTIC CONTAINER
NDA #050655		 SUPPL-23 NAFCILLIN SODIUM BAXTER HLTHCARE Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-3 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-4 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-2 RABEPRAZOLE SODIUM MYLAN Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-3 RABEPRAZOLE SODIUM MYLAN Labeling Approval
04/03/2015 NICOTINE POLACRILEX
ANDA #077007		 SUPPL-28 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
04/03/2015 HYDROCODONE
ANDA #077723		 SUPPL-4 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/03/2015 HYDROCODONE
ANDA #077723		 SUPPL-16 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/03/2015 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-4 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/03/2015 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-16 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-2 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-3 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-3 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-4 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
04/03/2015 LANSOPRAZOLE
ANDA #091269		 SUPPL-6 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
04/03/2015 SILDENAFIL CITRATE
ANDA #091479		 SUPPL-5 SILDENAFIL CITRATE TORRENT PHARMS LTD Labeling Approval
04/03/2015 TUDORZA PRESSAIR
NDA #202450		 SUPPL-5 ACLIDINIUM BROMIDE COVIS Labeling Approval
04/03/2015 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202713		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN ALEMBIC Approval
04/03/2015 ONDANSETRON HYDROCHLORIDE
ANDA #203711		 SUPPL-1 ONDANSETRON HYDROCHLORIDE QILU PHARM HAINAN Labeling Approval
04/03/2015 DEXTROAMPHETAMINE SULFATE
ANDA #203901		 SUPPL-4 DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Labeling Approval
04/03/2015 DOCETAXEL
ANDA #204193		 SUPPL-3 DOCETAXEL DR REDDYS Labeling Approval
04/03/2015 MOXIFLOXACIN HYDROCHLORIDE
NDA #205572		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
04/03/2015 CRESEMBA
NDA #207500		 SUPPL-1 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
04/03/2015 CRESEMBA
NDA #207501		 SUPPL-1 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
04/06/2015 HYDROXYZINE HYDROCHLORIDE
ANDA #040604		 SUPPL-3 HYDROXYZINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
04/06/2015 DIAZEPAM
ANDA #071583		 SUPPL-20 DIAZEPAM HOSPIRA Labeling Approval
04/06/2015 DIAZEPAM
ANDA #072079		 SUPPL-22 DIAZEPAM HOSPIRA Labeling Approval
04/06/2015 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-32 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
04/06/2015 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-33 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
04/06/2015 ACEBUTOLOL HYDROCHLORIDE
ANDA #075047		 SUPPL-7 ACEBUTOLOL HYDROCHLORIDE AMNEAL PHARM Labeling Approval
04/06/2015 URSODIOL
ANDA #075517		 SUPPL-11 URSODIOL EPIC PHARMA Labeling Approval
04/06/2015 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
ANDA #075591		 SUPPL-7 FAMOTIDINE BAXTER HLTHCARE Labeling Approval
04/06/2015 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-9 ENALAPRIL MALEATE TARO Manufacturing (CMC) Approval
04/06/2015 CARVEDILOL
ANDA #077346		 SUPPL-5 CARVEDILOL SUN PHARM INDS INC Labeling Approval
04/06/2015 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483		 SUPPL-7 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
04/06/2015 DORZOLAMIDE HYDROCHLORIDE
ANDA #077846		 SUPPL-5 DORZOLAMIDE HYDROCHLORIDE HIKMA Labeling Approval
04/06/2015 DIGOXIN
ANDA #078556		 SUPPL-5 DIGOXIN IMPAX LABS Labeling Approval
04/06/2015 DIGOXIN
ANDA #078556		 SUPPL-10 DIGOXIN IMPAX LABS Labeling Approval
04/06/2015 DORZOLAMIDE HYDROCHLORIDE
ANDA #078756		 SUPPL-6 DORZOLAMIDE HYDROCHLORIDE TEVA PHARMS Labeling Approval
04/06/2015 OMEPRAZOLE MAGNESIUM
ANDA #078878		 SUPPL-10 OMEPRAZOLE MAGNESIUM DR REDDYS LABS LTD Labeling Approval
04/06/2015 VERAPAMIL HYDROCHLORIDE
ANDA #078906		 SUPPL-5 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
04/06/2015 VERAPAMIL HYDROCHLORIDE
ANDA #078906		 SUPPL-6 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
04/06/2015 TRIAMCINOLONE ACETONIDE
ANDA #089797		 SUPPL-2 TRIAMCINOLONE ACETONIDE COSETTE Manufacturing (CMC) Approval
04/06/2015 TRIAMCINOLONE ACETONIDE
ANDA #089798		 SUPPL-2 TRIAMCINOLONE ACETONIDE COSETTE Manufacturing (CMC) Approval
04/06/2015 FINASTERIDE
ANDA #090061		 SUPPL-8 FINASTERIDE HETERO LABS LTD III Labeling Approval
04/06/2015 FINASTERIDE
ANDA #090061		 SUPPL-9 FINASTERIDE HETERO LABS LTD III Manufacturing (CMC) Approval
04/06/2015 AMPICILLIN AND SULBACTAM
ANDA #090339		 SUPPL-2 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/06/2015 AMPICILLIN AND SULBACTAM
ANDA #090339		 SUPPL-4 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/06/2015 AMPICILLIN AND SULBACTAM
ANDA #090349		 SUPPL-2 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/06/2015 AMPICILLIN AND SULBACTAM
ANDA #090349		 SUPPL-4 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/06/2015 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-3 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
04/06/2015 DORZOLAMIDE HYDROCHLORIDE
ANDA #091034		 SUPPL-1 DORZOLAMIDE HYDROCHLORIDE ZAMBON SPA Labeling Approval
04/06/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #201546		 SUPPL-2 CETIRIZINE HYDROCHLORIDE TARO Manufacturing (CMC) Approval
04/06/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #201546		 SUPPL-2 CETIRIZINE HYDROCHLORIDE TARO Manufacturing (CMC) Approval
04/06/2015 MORPHINE SULFATE
ANDA #203849		 ORIG-1 MORPHINE SULFATE ACTAVIS ELIZABETH Approval
04/06/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 ORIG-1 HYDROMORPHONE HYDROCHLORIDE PADAGIS US Approval
04/07/2015 MAXIDEX
NDA #013422		 SUPPL-41 DEXAMETHASONE HARROW EYE Manufacturing (CMC) Approval
04/07/2015 BACTRIM
NDA #017377		 SUPPL-75 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/07/2015 BACTRIM DS
NDA #017377		 SUPPL-75 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/07/2015 LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018461		 SUPPL-57 LIDOCAINE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/07/2015 LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018461		 SUPPL-57 LIDOCAINE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/07/2015 LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018461		 SUPPL-57 LIDOCAINE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/07/2015 LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018461		 SUPPL-57 LIDOCAINE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/07/2015 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-36 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/07/2015 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-36 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/07/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-36 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/07/2015 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-36 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/07/2015 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-36 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/07/2015 ADVIL PM
NDA #021394		 SUPPL-18 DIPHENHYDRAMINE CITRATE; IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
04/07/2015 MUCINEX DM
NDA #021620		 SUPPL-37 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
04/07/2015 DACOGEN
NDA #021790		 SUPPL-18 DECITABINE OTSUKA Manufacturing (CMC) Approval
04/07/2015 CLOBEX
NDA #021835		 SUPPL-8 CLOBETASOL PROPIONATE GALDERMA LABS LP Manufacturing (CMC) Approval
04/07/2015 LOSEASONIQUE
NDA #022262		 SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Manufacturing (CMC) Approval
04/07/2015 PROMACTA
NDA #022291		 SUPPL-14 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
04/07/2015 BESIVANCE
NDA #022308		 SUPPL-10 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
04/07/2015 ELLA
NDA #022474		 SUPPL-6 ULIPRISTAL ACETATE LAB HRA PHARMA Manufacturing (CMC) Approval
04/07/2015 PRADAXA
NDA #022512		 SUPPL-26 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/07/2015 COSMEGEN
NDA #050682		 SUPPL-31 DACTINOMYCIN RECORDATI RARE Manufacturing (CMC) Approval
04/07/2015 STROMECTOL
NDA #050742		 SUPPL-27 IVERMECTIN MERCK SHARP DOHME Manufacturing (CMC) Approval
04/07/2015 OXYCODONE HYDROCHLORIDE
ANDA #076636		 SUPPL-5 OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
04/07/2015 AMPICILLIN AND SULBACTAM
ANDA #090340		 SUPPL-2 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/07/2015 AMPICILLIN AND SULBACTAM
ANDA #090340		 SUPPL-4 AMPICILLIN SODIUM; SULBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/07/2015 SUMATRIPTAN SUCCINATE
ANDA #090495		 SUPPL-3 SUMATRIPTAN SUCCINATE DR REDDYS Manufacturing (CMC) Approval
04/07/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200383		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE NAARI PTE LTD Approval
04/07/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200384		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE NAARI PTE LTD Approval
04/07/2015 ZECUITY
NDA #202278		 SUPPL-7 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
04/07/2015 STRIBILD
NDA #203100		 SUPPL-12 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
04/07/2015 DOCETAXEL
NDA #203551		 SUPPL-3 DOCETAXEL ACTAVIS Manufacturing (CMC) Approval
04/07/2015 FLUDEOXYGLUCOSE F18
ANDA #204546		 ORIG-1 FLUDEOXYGLUCOSE F-18 PRECISION NUCLEAR Approval
04/08/2015 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-99 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/08/2015 MANNITOL 10%
NDA #016269		 SUPPL-51 MANNITOL HOSPIRA Manufacturing (CMC) Approval
04/08/2015 MANNITOL 15%
NDA #016269		 SUPPL-51 MANNITOL HOSPIRA Manufacturing (CMC) Approval
04/08/2015 MANNITOL 20%
NDA #016269		 SUPPL-51 MANNITOL HOSPIRA Manufacturing (CMC) Approval
04/08/2015 MANNITOL 25%
NDA #016269		 SUPPL-51 MANNITOL HOSPIRA Manufacturing (CMC) Approval
04/08/2015 MANNITOL 5%
NDA #016269		 SUPPL-51 MANNITOL HOSPIRA Manufacturing (CMC) Approval
04/08/2015 DIDRONEL
NDA #017831		 SUPPL-58 ETIDRONATE DISODIUM APIL Labeling Approval
04/08/2015 FOSAMAX
NDA #020560		 SUPPL-68 ALENDRONATE SODIUM ORGANON Labeling Approval
04/08/2015 ACTONEL
NDA #020835		 SUPPL-48 RISEDRONATE SODIUM APIL Labeling Approval
04/08/2015 BONIVA
NDA #021455		 SUPPL-20 IBANDRONATE SODIUM HOFFMANN LA ROCHE Labeling Approval
04/08/2015 FOSAMAX
NDA #021575		 SUPPL-24 ALENDRONATE SODIUM MERCK Labeling Approval
04/08/2015 FOSAMAX PLUS D
NDA #021762		 SUPPL-20 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
04/08/2015 ACTONEL WITH CALCIUM (COPACKAGED)
NDA #021823		 SUPPL-11 CALCIUM CARBONATE; RISEDRONATE SODIUM WARNER CHILCOTT Labeling Approval
04/08/2015 BONIVA
NDA #021858		 SUPPL-20 IBANDRONATE SODIUM ROCHE Labeling Approval
04/08/2015 ATELVIA
NDA #022560		 SUPPL-7 RISEDRONATE SODIUM APIL Labeling Approval
04/08/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076345		 SUPPL-19 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
04/08/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076345		 SUPPL-32 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #077056		 SUPPL-16 PANTOPRAZOLE SODIUM TEVA Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #077058		 SUPPL-16 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #077619		 SUPPL-10 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-17 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #090807		 SUPPL-4 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-8 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-9 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
04/08/2015 PROLIA
BLA #125320		 SUPPL-174 DENOSUMAB AMGEN Approval
04/08/2015 XGEVA
BLA #125320		 SUPPL-174 DENOSUMAB AMGEN Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #200794		 SUPPL-5 PANTOPRAZOLE SODIUM SUN PHARM INDS LTD Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #202038		 SUPPL-6 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
04/08/2015 PANTOPRAZOLE SODIUM
ANDA #202052		 SUPPL-1 PANTOPRAZOLE SODIUM ORBION PHARMS Labeling Approval
04/08/2015 BINOSTO
NDA #202344		 SUPPL-8 ALENDRONATE SODIUM RADIUS Labeling Approval
04/08/2015 VALACYCLOVIR HYDROCHLORIDE
ANDA #203047		 ORIG-1 VALACYCLOVIR HYDROCHLORIDE HETERO LABS LTD V Approval
04/08/2015 PROCYSBI
NDA #203389		 SUPPL-12 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
04/08/2015 RIZATRIPTAN BENZOATE
ANDA #204339		 SUPPL-2 RIZATRIPTAN BENZOATE INVAGEN PHARMS Labeling Approval
04/08/2015 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206010		 ORIG-1 ATRACURIUM BESYLATE EUGIA PHARMA Approval
04/08/2015 ATRACURIUM BESYLATE
ANDA #206011		 ORIG-1 ATRACURIUM BESYLATE EUGIA PHARMA Approval
04/09/2015 TESTIM
NDA #021454		 SUPPL-22 TESTOSTERONE AUXILIUM PHARMS LLC Manufacturing (CMC) Approval
04/09/2015 RIFADIN
NDA #050627		 SUPPL-15 RIFAMPIN SANOFI AVENTIS US Manufacturing (CMC) Approval
04/09/2015 AZITHROMYCIN
ANDA #065365		 SUPPL-9 AZITHROMYCIN MYLAN Labeling Approval
04/09/2015 AZITHROMYCIN
ANDA #065366		 SUPPL-8 AZITHROMYCIN MYLAN Labeling Approval
04/09/2015 MINOXIDIL
ANDA #071826		 SUPPL-9 MINOXIDIL PAR PHARM Manufacturing (CMC) Approval
04/09/2015 MINOXIDIL
ANDA #071826		 SUPPL-11 MINOXIDIL PAR PHARM Labeling Approval
04/09/2015 LISINOPRIL
ANDA #077321		 SUPPL-24 LISINOPRIL LUPIN Labeling Approval
04/09/2015 LISINOPRIL
ANDA #077321		 SUPPL-25 LISINOPRIL LUPIN Labeling Approval
04/09/2015 LISINOPRIL
ANDA #077321		 SUPPL-27 LISINOPRIL LUPIN Labeling Approval
04/09/2015 LISINOPRIL
ANDA #077321		 SUPPL-31 LISINOPRIL LUPIN Labeling Approval
04/09/2015 TECHNETIUM TC 99M SESTAMIBI
ANDA #078098		 SUPPL-3 TECHNETIUM TC-99M SESTAMIBI KIT CURIUM Labeling Approval
04/09/2015 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #078966		 SUPPL-8 OMEPRAZOLE; SODIUM BICARBONATE STRIDES PHARMA Labeling Approval
04/09/2015 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #079182		 SUPPL-2 OMEPRAZOLE; SODIUM BICARBONATE STRIDES PHARMA Labeling Approval
04/09/2015 PANTOPRAZOLE SODIUM
ANDA #090074		 SUPPL-12 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
04/09/2015 VERAPAMIL HYDROCHLORIDE
ANDA #090700		 SUPPL-2 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
04/09/2015 VERAPAMIL HYDROCHLORIDE
ANDA #090700		 SUPPL-3 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
04/09/2015 PANTOPRAZOLE SODIUM
ANDA #090797		 SUPPL-11 PANTOPRAZOLE SODIUM ACTAVIS TOTOWA Labeling Approval
04/09/2015 ZOLEDRONIC ACID
ANDA #091363		 SUPPL-1 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
04/09/2015 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-4 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
04/09/2015 CYTARABINE
ANDA #200915		 SUPPL-1 CYTARABINE RISING Labeling Approval
04/09/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202791		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Approval
04/10/2015 CREON
BLA #020725		 SUPPL-22 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
04/10/2015 MINOXIDIL
ANDA #071839		 SUPPL-11 MINOXIDIL PAR PHARM Labeling Approval
04/10/2015 PACLITAXEL
ANDA #075184		 SUPPL-16 PACLITAXEL TEVA PHARMS Labeling Approval
04/10/2015 IBUPROFEN
ANDA #079205		 SUPPL-4 IBUPROFEN MARKSANS PHARMA Labeling Approval
04/10/2015 MEMANTINE HYDROCHLORIDE
ANDA #090041		 ORIG-1 MEMANTINE HYDROCHLORIDE AMNEAL PHARMS Approval
04/10/2015 MEMANTINE HYDROCHLORIDE
ANDA #090051		 ORIG-1 MEMANTINE HYDROCHLORIDE LUPIN LTD Approval
04/10/2015 FOSPHENYTOIN SODIUM
ANDA #090099		 SUPPL-1 FOSPHENYTOIN SODIUM AM REGENT Labeling Approval
04/10/2015 ERBITUX
BLA #125084		 SUPPL-262 CETUXIMAB IMCLONE Approval
04/10/2015 LOSARTAN POTASSIUM
ANDA #201170		 SUPPL-1 LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/10/2015 LOSARTAN POTASSIUM
ANDA #201170		 SUPPL-3 LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/10/2015 LOSARTAN POTASSIUM
ANDA #201170		 SUPPL-5 LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/10/2015 HALAVEN
NDA #201532		 SUPPL-12 ERIBULIN MESYLATE EISAI INC Manufacturing (CMC) Approval
04/10/2015 IMPAVIDO
NDA #204684		 SUPPL-1 MILTEFOSINE KNIGHT THERAPS Manufacturing (CMC) Approval
04/10/2015 OLYSIO
NDA #205123		 SUPPL-9 SIMEPREVIR SODIUM JANSSEN PRODS Labeling Approval
04/13/2015 BACTRIM
NDA #017377		 SUPPL-76 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/13/2015 BACTRIM DS
NDA #017377		 SUPPL-76 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/13/2015 AKPENTOLATE
ANDA #040164		 SUPPL-6 CYCLOPENTOLATE HYDROCHLORIDE RISING Labeling Approval
04/13/2015 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040583		 SUPPL-6 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
04/13/2015 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040583		 SUPPL-7 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
04/13/2015 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040612		 SUPPL-5 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
04/13/2015 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040612		 SUPPL-6 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
04/13/2015 DESOWEN
ANDA #072354		 SUPPL-9 DESONIDE GALDERMA LABS LP Labeling Approval
04/13/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #074132		 SUPPL-24 NORTRIPTYLINE HYDROCHLORIDE TEVA Labeling Approval
04/13/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #074132		 SUPPL-26 NORTRIPTYLINE HYDROCHLORIDE TEVA Labeling Approval
04/13/2015 NICOTINE
ANDA #074612		 SUPPL-25 NICOTINE AVEVA Labeling Approval
04/13/2015 IBUPROFEN
ANDA #074916		 SUPPL-51 IBUPROFEN P AND L Manufacturing (CMC) Approval
04/13/2015 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #075256		 SUPPL-33 DESOGESTREL; ETHINYL ESTRADIOL DURAMED PHARMS BARR Labeling Approval
04/13/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #075520		 SUPPL-4 NORTRIPTYLINE HYDROCHLORIDE TARO Labeling Approval
04/13/2015 NORTRIPTYLINE HYDROCHLORIDE
ANDA #075520		 SUPPL-6 NORTRIPTYLINE HYDROCHLORIDE TARO Labeling Approval
04/13/2015 BISOPROLOL FUMARATE
ANDA #075644		 SUPPL-26 BISOPROLOL FUMARATE TEVA PHARMS Labeling Approval
04/13/2015 IBUPROFEN
ANDA #075661		 SUPPL-2 IBUPROFEN DR REDDYS LA Labeling Approval
04/13/2015 GLYBURIDE (MICRONIZED)
ANDA #075890		 SUPPL-4 GLYBURIDE HIKMA Labeling Approval
04/13/2015 GLYBURIDE (MICRONIZED)
ANDA #075890		 SUPPL-5 GLYBURIDE HIKMA Labeling Approval
04/13/2015 GLYBURIDE (MICRONIZED)
ANDA #075890		 SUPPL-6 GLYBURIDE HIKMA Labeling Approval
04/13/2015 LISINOPRIL
ANDA #075999		 SUPPL-10 LISINOPRIL RISING Labeling Approval
04/13/2015 LISINOPRIL
ANDA #075999		 SUPPL-11 LISINOPRIL RISING Labeling Approval
04/13/2015 GLYBURIDE
ANDA #076257		 SUPPL-10 GLYBURIDE EPIC PHARMA LLC Labeling Approval
04/13/2015 GLYBURIDE
ANDA #076257		 SUPPL-15 GLYBURIDE EPIC PHARMA LLC Labeling Approval
04/13/2015 CYCLAFEM 1/35
ANDA #076337		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE VINTAGE PHARMS LLC Labeling Approval
04/13/2015 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #076629		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE DR REDDYS LABS SA Labeling Approval
04/13/2015 EMOQUETTE
ANDA #076675		 SUPPL-6 DESOGESTREL; ETHINYL ESTRADIOL VINTAGE PHARMS LLC Labeling Approval
04/13/2015 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076915		 SUPPL-13 DESOGESTREL; ETHINYL ESTRADIOL WATSON LABS Labeling Approval
04/13/2015 METFORMIN HYDROCHLORIDE
ANDA #077064		 SUPPL-26 METFORMIN HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
04/13/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-6 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
04/13/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #078065		 SUPPL-4 PROPRANOLOL HYDROCHLORIDE NORTEC DEV ASSOC Labeling Approval
04/13/2015 ROPINIROLE HYDROCHLORIDE
ANDA #078110		 SUPPL-9 ROPINIROLE HYDROCHLORIDE PRINSTON INC Labeling Approval
04/13/2015 NAPROXEN
ANDA #078250		 SUPPL-12 NAPROXEN GLENMARK PHARMS LTD Labeling Approval
04/13/2015 IBUPROFEN
ANDA #079174		 SUPPL-1 IBUPROFEN GRANULES INDIA Labeling Approval
04/13/2015 PROCAINAMIDE HYDROCHLORIDE
ANDA #088636		 SUPPL-14 PROCAINAMIDE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
04/13/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #090182		 SUPPL-21 CETIRIZINE HYDROCHLORIDE TARO Labeling Approval
04/13/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #090182		 SUPPL-21 CETIRIZINE HYDROCHLORIDE TARO Labeling Approval
04/13/2015 VIORELE
ANDA #091346		 SUPPL-3 DESOGESTREL; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
04/13/2015 PIRMELLA 7/7/7
ANDA #201510		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Labeling Approval
04/13/2015 PIRMELLA 1/35
ANDA #201512		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Labeling Approval
04/13/2015 STIVARGA
NDA #203085		 SUPPL-4 REGORAFENIB BAYER HLTHCARE Labeling Approval
04/13/2015 METFORMIN HYDROCHLORIDE
ANDA #203686		 SUPPL-2 METFORMIN HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
04/13/2015 OLANZAPINE
ANDA #203708		 SUPPL-1 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
04/13/2015 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA #204559		 ORIG-1 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE STRIDES PHARMA Approval
04/13/2015 TRIAMCINOLONE ACETONIDE
ANDA #205782		 ORIG-1 TRIAMCINOLONE ACETONIDE PADAGIS ISRAEL Approval
04/14/2015 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-68 HEPARIN SODIUM HOSPIRA Manufacturing (CMC) Approval
04/14/2015 FLAGYL ER
NDA #020868		 SUPPL-10 METRONIDAZOLE PFIZER Manufacturing (CMC) Approval
04/14/2015 TRILEPTAL
NDA #021014		 SUPPL-38 OXCARBAZEPINE NOVARTIS Manufacturing (CMC) Approval
04/14/2015 DAYTRANA
NDA #021514		 SUPPL-20 METHYLPHENIDATE NOVEN PHARMS INC Manufacturing (CMC) Approval
04/14/2015 DAYTRANA
NDA #021514		 SUPPL-21 METHYLPHENIDATE NOVEN PHARMS INC Manufacturing (CMC) Approval
04/14/2015 SYMBICORT
NDA #021929		 SUPPL-38 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE ASTRAZENECA Manufacturing (CMC) Approval
04/14/2015 TOBI
NDA #050753		 SUPPL-17 TOBRAMYCIN MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/14/2015 CLOTRIMAZOLE
ANDA #074165		 SUPPL-33 CLOTRIMAZOLE P AND L Labeling Approval
04/14/2015 CLOTRIMAZOLE
ANDA #074165		 SUPPL-37 CLOTRIMAZOLE P AND L Labeling Approval
04/14/2015 ENALAPRILAT
ANDA #075578		 SUPPL-17 ENALAPRILAT DR REDDYS Labeling Approval
04/14/2015 OMEPRAZOLE
ANDA #075757		 SUPPL-38 OMEPRAZOLE SANDOZ Labeling Approval
04/14/2015 OMEPRAZOLE
ANDA #075757		 SUPPL-39 OMEPRAZOLE SANDOZ Labeling Approval
04/14/2015 OMEPRAZOLE
ANDA #075757		 SUPPL-42 OMEPRAZOLE SANDOZ Labeling Approval
04/14/2015 OMEPRAZOLE
ANDA #075757		 SUPPL-43 OMEPRAZOLE SANDOZ Labeling Approval
04/14/2015 OPDIVO
BLA #125554		 SUPPL-3 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
04/14/2015 OPDIVO
BLA #125554		 SUPPL-4 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
04/14/2015 POTASSIUM CHLORIDE
ANDA #200185		 SUPPL-1 POTASSIUM CHLORIDE PADAGIS US Labeling Approval
04/14/2015 ESOMEPRAZOLE SODIUM
ANDA #200882		 SUPPL-2 ESOMEPRAZOLE SODIUM SUN PHARM Labeling Approval
04/14/2015 ESOMEPRAZOLE SODIUM
ANDA #200882		 SUPPL-3 ESOMEPRAZOLE SODIUM SUN PHARM Labeling Approval
04/14/2015 BENZTROPINE MESYLATE
ANDA #204713		 ORIG-1 BENZTROPINE MESYLATE ASPEN GLOBAL INC Approval
04/14/2015 CEFIXIME
ANDA #204835		 ORIG-1 CEFIXIME AUROBINDO PHARMA LTD Approval
04/15/2015 DILANTIN-125
NDA #008762		 SUPPL-52 PHENYTOIN VIATRIS Labeling Approval
04/15/2015 DILANTIN-30
NDA #008762		 SUPPL-52 PHENYTOIN VIATRIS Labeling Approval
04/15/2015 DILANTIN
NDA #010151		 SUPPL-40 PHENYTOIN SODIUM PARKE DAVIS Labeling Approval
04/15/2015 TRIGLIDE
NDA #021350		 SUPPL-14 FENOFIBRATE SKYEPHARMA AG Labeling Approval
04/15/2015 SYNTHROID
NDA #021402		 SUPPL-27 LEVOTHYROXINE SODIUM ABBVIE Manufacturing (CMC) Approval
04/15/2015 VIMPAT
NDA #022253		 SUPPL-31 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
04/15/2015 DUAC
NDA #050741		 SUPPL-24 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE STIEFEL Labeling Approval
04/15/2015 SULINDAC
ANDA #072050		 SUPPL-32 SULINDAC SUN PHARM INDUSTRIES Labeling Approval
04/15/2015 SULINDAC
ANDA #072051		 SUPPL-37 SULINDAC SUN PHARM INDUSTRIES Labeling Approval
04/15/2015 NAPROXEN SODIUM
ANDA #074198		 SUPPL-35 NAPROXEN SODIUM TEVA Labeling Approval
04/15/2015 TOPICORT
ANDA #074286		 SUPPL-15 DESOXIMETASONE TARO Labeling Approval
04/15/2015 RANITIDINE HYDROCHLORIDE
ANDA #075294		 SUPPL-30 RANITIDINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
04/15/2015 NAPROXEN SODIUM
ANDA #075416		 SUPPL-12 NAPROXEN SODIUM ACTAVIS LABS FL INC Labeling Approval
04/15/2015 LISINOPRIL
ANDA #075994		 SUPPL-38 LISINOPRIL CHARTWELL RX Labeling Approval
04/15/2015 LISINOPRIL
ANDA #075994		 SUPPL-39 LISINOPRIL CHARTWELL RX Labeling Approval
04/15/2015 LISINOPRIL
ANDA #075994		 SUPPL-43 LISINOPRIL CHARTWELL RX Labeling Approval
04/15/2015 LISINOPRIL
ANDA #075994		 SUPPL-44 LISINOPRIL CHARTWELL RX Labeling Approval
04/15/2015 OLANZAPINE
ANDA #076000		 SUPPL-5 OLANZAPINE TEVA PHARMS Labeling Approval
04/15/2015 NICOTINE POLACRILEX
ANDA #076775		 SUPPL-22 NICOTINE POLACRILEX L PERRIGO CO Labeling Approval
04/15/2015 NICOTINE POLACRILEX
ANDA #076789		 SUPPL-22 NICOTINE POLACRILEX L PERRIGO CO Labeling Approval
04/15/2015 BROMOCRIPTINE MESYLATE
ANDA #077646		 SUPPL-4 BROMOCRIPTINE MESYLATE PADAGIS US Labeling Approval
04/15/2015 PRAVASTATIN SODIUM
ANDA #077793		 SUPPL-1 PRAVASTATIN SODIUM TEVA PHARMS Labeling Approval
04/15/2015 PRAVASTATIN SODIUM
ANDA #077793		 SUPPL-6 PRAVASTATIN SODIUM TEVA PHARMS Labeling Approval
04/15/2015 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-2 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
04/15/2015 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-23 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
04/15/2015 NICOTINE POLACRILEX
ANDA #078325		 SUPPL-13 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
04/15/2015 NICOTINE POLACRILEX
ANDA #078326		 SUPPL-14 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
04/15/2015 BACLOFEN
ANDA #078401		 SUPPL-4 BACLOFEN NORTHSTAR HLTHCARE Labeling Approval
04/15/2015 BACLOFEN
ANDA #078401		 SUPPL-5 BACLOFEN NORTHSTAR HLTHCARE Labeling Approval
04/15/2015 FOSPHENYTOIN SODIUM
ANDA #078476		 SUPPL-1 FOSPHENYTOIN SODIUM AMNEAL Labeling Approval
04/15/2015 FOSPHENYTOIN SODIUM
ANDA #078476		 SUPPL-2 FOSPHENYTOIN SODIUM AMNEAL Labeling Approval
04/15/2015 FOSPHENYTOIN SODIUM
ANDA #078476		 SUPPL-3 FOSPHENYTOIN SODIUM AMNEAL Labeling Approval
04/15/2015 FOSPHENYTOIN SODIUM
ANDA #078476		 SUPPL-5 FOSPHENYTOIN SODIUM AMNEAL Labeling Approval
04/15/2015 BACLOFEN
ANDA #078504		 SUPPL-4 BACLOFEN NORTHSTAR HLTHCARE Labeling Approval
04/15/2015 BACLOFEN
ANDA #078504		 SUPPL-5 BACLOFEN NORTHSTAR HLTHCARE Labeling Approval
04/15/2015 PERINDOPRIL ERBUMINE
ANDA #090463		 SUPPL-1 PERINDOPRIL ERBUMINE APOTEX Labeling Approval
04/15/2015 IMIPENEM AND CILASTATIN
ANDA #090577		 SUPPL-1 CILASTATIN SODIUM; IMIPENEM ACS DOBFAR Labeling Approval
04/15/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263		 SUPPL-4 LEVOCETIRIZINE DIHYDROCHLORIDE PADAGIS US Labeling Approval
04/15/2015 ALPRAZOLAM
ANDA #200739		 ORIG-1 ALPRAZOLAM NATCO Approval
04/15/2015 BUPROPION HYDROCHLORIDE
ANDA #202189		 SUPPL-3 BUPROPION HYDROCHLORIDE WOCKHARDT LTD Labeling Approval
04/15/2015 TYBOST
NDA #203094		 SUPPL-1 COBICISTAT GILEAD SCIENCES INC Manufacturing (CMC) Approval
04/15/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #204226		 SUPPL-5 CETIRIZINE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
04/15/2015 OLYSIO
NDA #205123		 SUPPL-8 SIMEPREVIR SODIUM JANSSEN PRODS Labeling Approval
04/15/2015 CORLANOR
NDA #206143		 ORIG-1 IVABRADINE HYDROCHLORIDE AMGEN INC Type 1 - New Molecular Entity Approval
04/16/2015 PRIMAQUINE
NDA #008316		 SUPPL-21 PRIMAQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
04/16/2015 SPORANOX
NDA #020083		 SUPPL-58 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
04/16/2015 CHILDREN'S MOTRIN
NDA #020516		 SUPPL-30 IBUPROFEN J AND J CONSUMER INC Labeling Approval
04/16/2015 CLARITIN
NDA #020641		 SUPPL-36 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/16/2015 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-36 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/16/2015 SPORANOX
NDA #020657		 SUPPL-33 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
04/16/2015 RECLAST
NDA #021817		 SUPPL-21 ZOLEDRONIC ACID SANDOZ Labeling Approval
04/16/2015 NUVIGIL
NDA #021875		 SUPPL-21 ARMODAFINIL CEPHALON Labeling Approval
04/16/2015 NICORETTE
NDA #022360		 SUPPL-9 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
04/16/2015 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-48 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Efficacy Approval
04/16/2015 EPIRUBICIN HYDROCHLORIDE
ANDA #065343		 SUPPL-5 EPIRUBICIN HYDROCHLORIDE HOSPIRA Labeling Approval
04/16/2015 EPIRUBICIN HYDROCHLORIDE
ANDA #065343		 SUPPL-7 EPIRUBICIN HYDROCHLORIDE HOSPIRA Labeling Approval
04/16/2015 NADOLOL
ANDA #074229		 SUPPL-16 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 NADOLOL
ANDA #074229		 SUPPL-18 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 NADOLOL
ANDA #074229		 SUPPL-19 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 NADOLOL
ANDA #074255		 SUPPL-16 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 NADOLOL
ANDA #074255		 SUPPL-18 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 NADOLOL
ANDA #074255		 SUPPL-19 NADOLOL HERITAGE PHARMA Labeling Approval
04/16/2015 TRAMADOL HYDROCHLORIDE
ANDA #076003		 SUPPL-13 TRAMADOL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
04/16/2015 TRAMADOL HYDROCHLORIDE
ANDA #076003		 SUPPL-30 TRAMADOL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
04/16/2015 NAPROXEN
ANDA #076494		 SUPPL-12 NAPROXEN HIKMA INTL PHARMS Labeling Approval
04/16/2015 BACLOFEN
ANDA #077241		 SUPPL-1 BACLOFEN LANNETT CO INC Labeling Approval
04/16/2015 BACLOFEN
ANDA #077241		 SUPPL-11 BACLOFEN LANNETT CO INC Labeling Approval
04/16/2015 DILANTIN
ANDA #084349		 SUPPL-74 PHENYTOIN SODIUM VIATRIS Labeling Approval
04/16/2015 DILANTIN
ANDA #084427		 SUPPL-32 PHENYTOIN PHARMACIA Labeling Approval
04/16/2015 GLATOPA
ANDA #090218		 ORIG-1 GLATIRAMER ACETATE SANDOZ Approval
04/16/2015 EDARBYCLOR
NDA #202331		 SUPPL-7 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE AZURITY Labeling Approval
04/16/2015 ESCITALOPRAM OXALATE
ANDA #202389		 SUPPL-4 ESCITALOPRAM OXALATE ACCORD HLTHCARE Labeling Approval
04/16/2015 NEBIVOLOL HYDROCHLORIDE
ANDA #203659		 ORIG-1 NEBIVOLOL HYDROCHLORIDE ANI PHARMS Approval
04/16/2015 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-1 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
04/16/2015 ZONTIVITY
NDA #204886		 SUPPL-2 VORAPAXAR SULFATE XSPIRE PHARMA Labeling Approval
04/17/2015 DESOXYN
NDA #005378		 SUPPL-30 METHAMPHETAMINE HYDROCHLORIDE AJENAT PHARMS Labeling Approval
04/17/2015 RITALIN
NDA #010187		 SUPPL-80 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
04/17/2015 ADDERALL 10
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 12.5
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 15
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 20
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 30
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 5
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 ADDERALL 7.5
NDA #011522		 SUPPL-41 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Labeling Approval
04/17/2015 DEXEDRINE
NDA #017078		 SUPPL-48 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
04/17/2015 REGLAN
NDA #017854		 SUPPL-60 METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
04/17/2015 RITALIN-SR
NDA #018029		 SUPPL-49 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
04/17/2015 CYKLOKAPRON
NDA #019281		 SUPPL-34 TRANEXAMIC ACID PFIZER Manufacturing (CMC) Approval
04/17/2015 DIPRIVAN
NDA #019627		 SUPPL-64 PROPOFOL FRESENIUS KABI USA Manufacturing (CMC) Approval
04/17/2015 FLOLAN
NDA #020444		 SUPPL-21 EPOPROSTENOL SODIUM GLAXOSMITHKLINE LLC Manufacturing (CMC) Approval
04/17/2015 NOVOLOG
BLA #020986		 SUPPL-82 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-82 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-82 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG INNOLET
BLA #020986		 SUPPL-82 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG PENFILL
BLA #020986		 SUPPL-82 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 CONCERTA
NDA #021121		 SUPPL-35 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
04/17/2015 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-64 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-64 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-64 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/17/2015 METADATE CD
NDA #021259		 SUPPL-29 METHYLPHENIDATE HYDROCHLORIDE AYTU BIOPHARMA Labeling Approval
04/17/2015 FOCALIN
NDA #021278		 SUPPL-18 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
04/17/2015 RITALIN LA
NDA #021284		 SUPPL-27 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
04/17/2015 ADDERALL XR 10
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 ADDERALL XR 15
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 ADDERALL XR 20
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 ADDERALL XR 25
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 ADDERALL XR 30
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 ADDERALL XR 5
NDA #021303		 SUPPL-31 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 STRATTERA
NDA #021411		 SUPPL-47 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
04/17/2015 METHYLIN
NDA #021419		 SUPPL-9 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
04/17/2015 METHYLIN
NDA #021475		 SUPPL-9 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
04/17/2015 DAYTRANA
NDA #021514		 SUPPL-22 METHYLPHENIDATE NOVEN PHARMS INC Labeling Approval
04/17/2015 TRICOR
NDA #021656		 SUPPL-25 FENOFIBRATE ABBVIE Manufacturing (CMC) Approval
04/17/2015 VISIONBLUE
NDA #021670		 SUPPL-7 TRYPAN BLUE DORC Manufacturing (CMC) Approval
04/17/2015 FOCALIN XR
NDA #021802		 SUPPL-28 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
04/17/2015 HYLENEX RECOMBINANT
BLA #021859		 SUPPL-21 HYALURONIDASE RECOMBINANT HUMAN HALOZYME THERAP Approval
04/17/2015 VYVANSE
NDA #021977		 SUPPL-39 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
04/17/2015 TRILIPIX
NDA #022224		 SUPPL-10 CHOLINE FENOFIBRATE ABBVIE Manufacturing (CMC) Approval
04/17/2015 AFREZZA
BLA #022472		 SUPPL-3 INSULIN RECOMBINANT HUMAN MANNKIND Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #040299		 SUPPL-2 DEXTROAMPHETAMINE SULFATE STRIDES PHARMA Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #040361		 SUPPL-19 DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422		 SUPPL-38 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #040436		 SUPPL-10 DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040439		 SUPPL-18 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SANDOZ Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040440		 SUPPL-12 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-18 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040456		 SUPPL-4 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040472		 SUPPL-7 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA PHARMS Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040480		 SUPPL-18 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SUN PHARM INDUSTRIES Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #040776		 SUPPL-2 DEXTROAMPHETAMINE SULFATE PRASCO Labeling Approval
04/17/2015 AUGMENTIN '200'
NDA #050725		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
04/17/2015 AUGMENTIN '400'
NDA #050725		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
04/17/2015 NITROFURANTOIN
ANDA #073652		 SUPPL-21 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Labeling Approval
04/17/2015 NITROFURANTOIN
ANDA #073652		 SUPPL-29 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Labeling Approval
04/17/2015 NITROFURANTOIN
ANDA #073671		 SUPPL-25 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Labeling Approval
04/17/2015 NITROFURANTOIN
ANDA #073671		 SUPPL-33 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Labeling Approval
04/17/2015 GABAPENTIN
ANDA #075360		 SUPPL-11 GABAPENTIN GRANULES Labeling Approval
04/17/2015 GABAPENTIN
ANDA #075360		 SUPPL-13 GABAPENTIN GRANULES Labeling Approval
04/17/2015 GABAPENTIN
ANDA #075360		 SUPPL-17 GABAPENTIN GRANULES Labeling Approval
04/17/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076344		 SUPPL-13 BENAZEPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/17/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076344		 SUPPL-14 BENAZEPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/17/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076344		 SUPPL-15 BENAZEPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/17/2015 GABAPENTIN
ANDA #077661		 SUPPL-8 GABAPENTIN RUBICON Labeling Approval
04/17/2015 GABAPENTIN
ANDA #077661		 SUPPL-12 GABAPENTIN RUBICON Labeling Approval
04/17/2015 GABAPENTIN
ANDA #077894		 SUPPL-4 GABAPENTIN APOTEX Labeling Approval
04/17/2015 GABAPENTIN
ANDA #077894		 SUPPL-5 GABAPENTIN APOTEX Labeling Approval
04/17/2015 GEMCITABINE HYDROCHLORIDE
ANDA #078433		 SUPPL-3 GEMCITABINE HYDROCHLORIDE SUN PHARM Labeling Approval
04/17/2015 AMPHETAMINE SULFATE
ANDA #083901		 SUPPL-3 AMPHETAMINE SULFATE LANNETT Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #083903		 SUPPL-26 DEXTROAMPHETAMINE SULFATE LANNETT Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #085652		 SUPPL-3 DEXTROAMPHETAMINE SULFATE LANNETT Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #090533		 SUPPL-5 DEXTROAMPHETAMINE SULFATE AZURITY Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #090652		 SUPPL-2 DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
04/17/2015 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-3 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
04/17/2015 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-5 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
04/17/2015 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-6 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
04/17/2015 BOTOX
BLA #103000		 SUPPL-5282 OnabotulinumtoxinA ALLERGAN Approval
04/17/2015 BOTOX COSMETIC
BLA #103000		 SUPPL-5282 OnabotulinumtoxinA ALLERGAN Approval
04/17/2015 EVEKEO
ANDA #200166		 SUPPL-3 AMPHETAMINE SULFATE AZURITY Labeling Approval
04/17/2015 TROKENDI XR
NDA #201635		 SUPPL-6 TOPIRAMATE SUPERNUS PHARMS Manufacturing (CMC) Approval
04/17/2015 QUILLIVANT XR
NDA #202100		 SUPPL-4 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Labeling Approval
04/17/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #202424		 SUPPL-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE AUROLIFE PHARMA LLC Labeling Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #202893		 SUPPL-1 DEXTROAMPHETAMINE SULFATE AUROLIFE PHARMA LLC Labeling Approval
04/17/2015 TYBOST
NDA #203094		 SUPPL-2 COBICISTAT GILEAD SCIENCES INC Manufacturing (CMC) Approval
04/17/2015 ICLUSIG
NDA #203469		 SUPPL-16 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
04/17/2015 DEXTROAMPHETAMINE SULFATE
ANDA #203644		 SUPPL-1 DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Labeling Approval
04/17/2015 TIMOLOL MALEATE
ANDA #204936		 ORIG-1 TIMOLOL MALEATE APOTEX Approval
04/17/2015 APTENSIO XR
NDA #205831		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE RHODES PHARMS Type 3 - New Dosage Form Approval
04/20/2015 PEPCID AC
NDA #020325		 SUPPL-26 FAMOTIDINE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/20/2015 BYSTOLIC
NDA #021742		 SUPPL-20 NEBIVOLOL HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
04/20/2015 DESMOPRESSIN ACETATE
NDA #021795		 SUPPL-5 DESMOPRESSIN ACETATE FERRING Manufacturing (CMC) Approval
04/20/2015 AFREZZA
BLA #022472		 SUPPL-2 INSULIN RECOMBINANT HUMAN MANNKIND Approval
04/20/2015 OXAZEPAM
ANDA #071756		 SUPPL-14 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/20/2015 OXAZEPAM
ANDA #071813		 SUPPL-14 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/20/2015 OXAZEPAM
ANDA #071814		 SUPPL-13 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/20/2015 PACLITAXEL
ANDA #077574		 SUPPL-5 PACLITAXEL FRESENIUS KABI USA Labeling Approval
04/20/2015 DESOXIMETASONE
ANDA #077770		 ORIG-1 DESOXIMETASONE PADAGIS ISRAEL Approval
04/20/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #077909		 SUPPL-6 FLUCONAZOLE WOODWARD Manufacturing (CMC) Approval
04/20/2015 FLUOROURACIL
ANDA #203122		 ORIG-1 FLUOROURACIL MYLAN Approval
04/20/2015 OSPHENA
NDA #203505		 SUPPL-7 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
04/20/2015 SODIUM FLUORIDE F-18
ANDA #204497		 ORIG-1 SODIUM FLUORIDE F-18 UNIV UTAH CYCLOTRON Approval
04/21/2015 NEURONTIN
NDA #020235		 SUPPL-61 GABAPENTIN VIATRIS Labeling Approval
04/21/2015 INVIRASE
NDA #020628		 SUPPL-39 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Labeling Approval
04/21/2015 NEURONTIN
NDA #020882		 SUPPL-44 GABAPENTIN VIATRIS Labeling Approval
04/21/2015 AGGRASTAT
NDA #020912		 SUPPL-21 TIROFIBAN HYDROCHLORIDE MEDICURE Labeling Approval
04/21/2015 AGGRASTAT
NDA #020913		 SUPPL-18 TIROFIBAN HYDROCHLORIDE MEDICURE Labeling Approval
04/21/2015 NEURONTIN
NDA #021129		 SUPPL-43 GABAPENTIN VIATRIS Labeling Approval
04/21/2015 INVIRASE
NDA #021785		 SUPPL-16 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
04/21/2015 SUPPRELIN LA
NDA #022058		 SUPPL-12 HISTRELIN ACETATE ENDO PHARM Manufacturing (CMC) Approval
04/21/2015 SELZENTRY
NDA #022128		 SUPPL-15 MARAVIROC VIIV HLTHCARE Labeling Approval
04/21/2015 MORPHINE SULFATE
NDA #022195		 SUPPL-7 MORPHINE SULFATE HIKMA Manufacturing (CMC) Approval
04/21/2015 LIVALO
NDA #022363		 SUPPL-13 PITAVASTATIN CALCIUM KOWA CO Manufacturing (CMC) Approval
04/21/2015 ACHROMYCIN V
NDA #050278		 SUPPL-36 TETRACYCLINE HYDROCHLORIDE AVET Manufacturing (CMC) Approval
04/21/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Approval
04/21/2015 KYPROLIS
NDA #202714		 SUPPL-6 CARFILZOMIB ONYX PHARMS AMGEN Manufacturing (CMC) Approval
04/21/2015 METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
ANDA #204144		 ORIG-1 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ANCHEN PHARMS Tentative Approval
04/22/2015 LOTREL
NDA #020364		 SUPPL-60 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Labeling Approval
04/22/2015 SPIRIVA
NDA #021395		 SUPPL-39 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/22/2015 SOLTAMOX
NDA #021807		 SUPPL-3 TAMOXIFEN CITRATE MAYNE PHARMA COMMRCL Manufacturing (CMC) Approval
04/22/2015 ERYTHROCIN
NDA #050609		 SUPPL-35 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
04/22/2015 CAPTOPRIL
ANDA #074434		 SUPPL-13 CAPTOPRIL AUROBINDO PHARMA USA Labeling Approval
04/22/2015 CAPTOPRIL
ANDA #074434		 SUPPL-14 CAPTOPRIL AUROBINDO PHARMA USA Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076211		 SUPPL-18 BENAZEPRIL HYDROCHLORIDE TEVA Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076211		 SUPPL-19 BENAZEPRIL HYDROCHLORIDE TEVA Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076211		 SUPPL-20 BENAZEPRIL HYDROCHLORIDE TEVA Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076430		 SUPPL-8 BENAZEPRIL HYDROCHLORIDE RISING Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076430		 SUPPL-9 BENAZEPRIL HYDROCHLORIDE RISING Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076688		 SUPPL-10 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE AUROBINDO PHARMA USA Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076688		 SUPPL-12 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE AUROBINDO PHARMA USA Labeling Approval
04/22/2015 MORPHINE SULFATE
ANDA #076720		 SUPPL-12 MORPHINE SULFATE NESHER PHARMS Labeling Approval
04/22/2015 MORPHINE SULFATE
ANDA #076733		 SUPPL-11 MORPHINE SULFATE NESHER PHARMS Labeling Approval
04/22/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #076798		 SUPPL-1 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/22/2015 PIOGLITAZONE HYDROCHLORIDE
ANDA #076798		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076820		 SUPPL-12 BENAZEPRIL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
04/22/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076820		 SUPPL-14 BENAZEPRIL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
04/22/2015 MORPHINE SULFATE
ANDA #077855		 SUPPL-7 MORPHINE SULFATE NESHER PHARMS Labeling Approval
04/22/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #078225		 SUPPL-5 TAMSULOSIN HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
04/22/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #078225		 SUPPL-6 TAMSULOSIN HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
04/22/2015 AUVI-Q
NDA #201739		 SUPPL-3 EPINEPHRINE KALEO INC Manufacturing (CMC) Approval
04/22/2015 FLUDEOXYGLUCOSE F18
ANDA #203911		 ORIG-1 FLUDEOXYGLUCOSE F-18 NUKEMED Approval
04/22/2015 SODIUM FLUORIDE F-18
ANDA #203912		 ORIG-1 SODIUM FLUORIDE F-18 NUKEMED Approval
04/22/2015 AMMONIA N 13
ANDA #204667		 ORIG-1 AMMONIA N-13 SOFIE Approval
04/23/2015 VALCYTE
NDA #021304		 SUPPL-11 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Efficacy Approval
04/23/2015 XIFAXAN
NDA #021361		 SUPPL-14 RIFAXIMIN SALIX PHARMS Manufacturing (CMC) Approval
04/23/2015 SPIRIVA
NDA #021395		 SUPPL-38 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/23/2015 VALCYTE
NDA #022257		 SUPPL-5 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Efficacy Approval
04/23/2015 DULERA
NDA #022518		 SUPPL-15 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
04/23/2015 MODAFINIL
ANDA #076715		 SUPPL-1 MODAFINIL WATSON LABS INC Manufacturing (CMC) Approval
04/23/2015 RISPERIDONE
ANDA #078452		 SUPPL-5 RISPERIDONE AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
04/23/2015 LANSOPRAZOLE
ANDA #091509		 SUPPL-7 LANSOPRAZOLE SUN PHARM Manufacturing (CMC) Approval
04/23/2015 ZOLEDRONIC ACID
ANDA #091516		 ORIG-1 ZOLEDRONIC ACID FRESENIUS KABI USA Approval
04/23/2015 HERCEPTIN
BLA #103792		 SUPPL-5327 TRASTUZUMAB GENENTECH Approval
04/23/2015 DONEPEZIL HYDROCHLORIDE
ANDA #201787		 SUPPL-2 DONEPEZIL HYDROCHLORIDE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
04/23/2015 CAPECITABINE
ANDA #202593		 ORIG-1 CAPECITABINE ACCORD HLTHCARE Approval
04/23/2015 ICLUSIG
NDA #203469		 SUPPL-17 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
04/23/2015 OSPHENA
NDA #203505		 SUPPL-6 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
04/23/2015 JUXTAPID
NDA #203858		 SUPPL-10 LOMITAPIDE MESYLATE CHIESI Labeling Approval
04/23/2015 FLUDEOXYGLUCOSE F18
ANDA #203904		 ORIG-1 FLUDEOXYGLUCOSE F-18 METHODIST HOSP RES Approval
04/23/2015 POMALYST
NDA #204026		 SUPPL-5 POMALIDOMIDE BRISTOL Labeling Approval
04/23/2015 POMALYST
NDA #204026		 SUPPL-6 POMALIDOMIDE BRISTOL Efficacy Approval
04/23/2015 POMALYST
NDA #204026		 SUPPL-8 POMALIDOMIDE BRISTOL Labeling Approval
04/23/2015 AMMONIA N 13
ANDA #204455		 ORIG-1 AMMONIA N-13 NUKEMED Approval
04/23/2015 VARITHENA
NDA #205098		 SUPPL-7 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
04/23/2015 BELEODAQ
NDA #206256		 SUPPL-1 BELINOSTAT ACROTECH BIOPHARMA Manufacturing (CMC) Approval
04/24/2015 AVC
NDA #006530		 SUPPL-20 SULFANILAMIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/24/2015 HUMALOG MIX 75/25
BLA #021017		 SUPPL-110 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/24/2015 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-110 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/24/2015 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-110 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
04/24/2015 SUTENT
NDA #021938		 SUPPL-28 SUNITINIB MALATE CPPI CV Labeling Approval
04/24/2015 SUTENT
NDA #021938		 SUPPL-29 SUNITINIB MALATE CPPI CV Labeling Approval
04/24/2015 VINCRISTINE SULFATE PFS
ANDA #071484		 SUPPL-39 VINCRISTINE SULFATE HOSPIRA Manufacturing (CMC) Approval
04/24/2015 FENOPROFEN CALCIUM
ANDA #072267		 SUPPL-22 FENOPROFEN CALCIUM XSPIRE PHARMA Labeling Approval
04/24/2015 LISINOPRIL
ANDA #075752		 SUPPL-36 LISINOPRIL HERITAGE PHARMA Labeling Approval
04/24/2015 LISINOPRIL
ANDA #075752		 SUPPL-37 LISINOPRIL HERITAGE PHARMA Labeling Approval
04/24/2015 LISINOPRIL
ANDA #075752		 SUPPL-38 LISINOPRIL HERITAGE PHARMA Labeling Approval
04/24/2015 LISINOPRIL
ANDA #075752		 SUPPL-39 LISINOPRIL HERITAGE PHARMA Labeling Approval
04/24/2015 GLIMEPIRIDE
ANDA #077091		 SUPPL-9 GLIMEPIRIDE DR REDDYS LABS LTD Labeling Approval
04/24/2015 GLIMEPIRIDE
ANDA #077091		 SUPPL-11 GLIMEPIRIDE DR REDDYS LABS LTD Labeling Approval
04/24/2015 GLIMEPIRIDE
ANDA #077091		 SUPPL-12 GLIMEPIRIDE DR REDDYS LABS LTD Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093		 SUPPL-10 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE MYLAN Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093		 SUPPL-11 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE MYLAN Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093		 SUPPL-13 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE MYLAN Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093		 SUPPL-14 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE MYLAN Labeling Approval
04/24/2015 GLIMEPIRIDE
ANDA #077295		 SUPPL-6 GLIMEPIRIDE CHARTWELL MOLECULAR Labeling Approval
04/24/2015 GLIMEPIRIDE
ANDA #077295		 SUPPL-8 GLIMEPIRIDE CHARTWELL MOLECULAR Labeling Approval
04/24/2015 ZONISAMIDE
ANDA #077634		 SUPPL-8 ZONISAMIDE SUN PHARM INDS (IN) Labeling Approval
04/24/2015 TRANDOLAPRIL
ANDA #078438		 SUPPL-7 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
04/24/2015 TRANDOLAPRIL
ANDA #078438		 SUPPL-8 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
04/24/2015 TRANDOLAPRIL
ANDA #078438		 SUPPL-12 TRANDOLAPRIL AUROBINDO PHARMA Labeling Approval
04/24/2015 REPAGLINIDE
ANDA #091517		 ORIG-1 REPAGLINIDE KENTON Approval
04/24/2015 CYRAMZA
BLA #125477		 SUPPL-11 RAMUCIRUMAB ELI LILLY AND CO Approval
04/24/2015 PARICALCITOL
NDA #201657		 SUPPL-1 PARICALCITOL HOSPIRA Manufacturing (CMC) Approval
04/24/2015 KYPROLIS
NDA #202714		 SUPPL-7 CARFILZOMIB ONYX PHARMS AMGEN Manufacturing (CMC) Approval
04/24/2015 QUININE SULFATE
ANDA #203112		 ORIG-1 QUININE SULFATE LUPIN LTD Approval
04/24/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #203506		 ORIG-1 OXYMORPHONE HYDROCHLORIDE SUN PHARM INDS LTD Approval
04/24/2015 JUXTAPID
NDA #203858		 SUPPL-11 LOMITAPIDE MESYLATE CHIESI Manufacturing (CMC) Approval
04/24/2015 BUNAVAIL
NDA #205637		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI Manufacturing (CMC) Approval
04/26/2015 KIONEX
ANDA #040028		 SUPPL-12 SODIUM POLYSTYRENE SULFONATE ANI PHARMS Labeling Approval
04/26/2015 SPIRONOLACTONE
ANDA #040424		 SUPPL-18 SPIRONOLACTONE MYLAN Labeling Approval
04/26/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-13 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/26/2015 ZOLEDRONIC ACID
ANDA #202828		 SUPPL-3 ZOLEDRONIC ACID INFORLIFE Labeling Approval
04/26/2015 ZOLEDRONIC ACID
ANDA #202828		 SUPPL-4 ZOLEDRONIC ACID INFORLIFE Labeling Approval
04/27/2015 ROGAINE (FOR MEN)
NDA #019501		 SUPPL-29 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
04/27/2015 ROGAINE (FOR WOMEN)
NDA #019501		 SUPPL-29 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
04/27/2015 NIASPAN
NDA #020381		 SUPPL-51 NIACIN ABBVIE Labeling Approval
04/27/2015 NIASPAN TITRATION STARTER PACK
NDA #020381		 SUPPL-51 NIACIN ABBVIE Labeling Approval
04/27/2015 ROGAINE EXTRA STRENGTH (FOR MEN)
NDA #020834		 SUPPL-14 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
04/27/2015 TARCEVA
NDA #021743		 SUPPL-21 ERLOTINIB HYDROCHLORIDE OSI PHARMS Efficacy Approval
04/27/2015 REVATIO
NDA #021845		 SUPPL-16 SILDENAFIL CITRATE VIATRIS Labeling Approval
04/27/2015 JANUVIA
NDA #021995		 SUPPL-33 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
04/27/2015 JANUMET
NDA #022044		 SUPPL-34 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
04/27/2015 TRILIPIX
NDA #022224		 SUPPL-11 CHOLINE FENOFIBRATE ABBVIE Labeling Approval
04/27/2015 REVATIO
NDA #022473		 SUPPL-10 SILDENAFIL CITRATE VIATRIS Labeling Approval
04/27/2015 ACHROMYCIN V
NDA #050278		 SUPPL-37 TETRACYCLINE HYDROCHLORIDE AVET Labeling Approval
04/27/2015 MEXILETINE HYDROCHLORIDE
ANDA #074377		 SUPPL-16 MEXILETINE HYDROCHLORIDE TEVA Labeling Approval
04/27/2015 MEXILETINE HYDROCHLORIDE
ANDA #074711		 SUPPL-8 MEXILETINE HYDROCHLORIDE WATSON LABS Labeling Approval
04/27/2015 MEXILETINE HYDROCHLORIDE
ANDA #074865		 SUPPL-2 MEXILETINE HYDROCHLORIDE WATSON LABS Labeling Approval
04/27/2015 OXYCODONE HYDROCHLORIDE
ANDA #077290		 SUPPL-7 OXYCODONE HYDROCHLORIDE NESHER PHARMS Labeling Approval
04/27/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #078311		 SUPPL-4 PROPRANOLOL HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
04/27/2015 PREGABALIN
ANDA #091221		 ORIG-1 PREGABALIN WATSON LABS INC Tentative Approval
04/27/2015 JANUMET XR
NDA #202270		 SUPPL-9 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
04/27/2015 REVATIO
NDA #203109		 SUPPL-9 SILDENAFIL CITRATE VIATRIS Labeling Approval
04/27/2015 OTEZLA
NDA #205437		 SUPPL-4 APREMILAST AMGEN INC Manufacturing (CMC) Approval
04/27/2015 AKYNZEO
NDA #205718		 SUPPL-3 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
04/28/2015 AZTREONAM
ANDA #065439		 SUPPL-4 AZTREONAM FRESENIUS KABI USA Labeling Approval
04/28/2015 AZTREONAM
ANDA #065439		 SUPPL-5 AZTREONAM FRESENIUS KABI USA Labeling Approval
04/28/2015 SOTALOL HYDROCHLORIDE
ANDA #075563		 SUPPL-7 SOTALOL HYDROCHLORIDE OXFORD PHARMS Labeling Approval
04/28/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #078212		 SUPPL-10 BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/28/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #078212		 SUPPL-13 BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/28/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #078212		 SUPPL-14 BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/28/2015 GRANISETRON HYDROCHLORIDE
ANDA #078531		 SUPPL-3 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/28/2015 GRANISETRON HYDROCHLORIDE
ANDA #078534		 SUPPL-3 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/28/2015 ARIPIPRAZOLE
ANDA #078607		 ORIG-1 ARIPIPRAZOLE TEVA PHARMS USA Approval
04/28/2015 ARIPIPRAZOLE
ANDA #078608		 ORIG-1 ARIPIPRAZOLE TEVA PHARMS USA Approval
04/28/2015 ARIPIPRAZOLE
ANDA #078708		 ORIG-1 ARIPIPRAZOLE TEVA PHARMS USA Approval
04/28/2015 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-10 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
04/28/2015 MONTELUKAST SODIUM
ANDA #090955		 SUPPL-6 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
04/28/2015 MONTELUKAST SODIUM
ANDA #090955		 SUPPL-7 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
04/28/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200494		 SUPPL-6 ETHINYL ESTRADIOL; NORGESTIMATE GLENMARK PHARMS LTD Labeling Approval
04/28/2015 NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #200494		 SUPPL-6 NORGESTIMATE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
04/28/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200538		 SUPPL-3 ETHINYL ESTRADIOL; NORGESTIMATE GLENMARK PHARMS LTD Labeling Approval
04/28/2015 ARIPIPRAZOLE
ANDA #201519		 ORIG-1 ARIPIPRAZOLE TORRENT Approval
04/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-3 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/28/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-5 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
04/28/2015 ARIPIPRAZOLE
ANDA #202101		 ORIG-1 ARIPIPRAZOLE ALEMBIC Approval
04/28/2015 ARIPIPRAZOLE
ANDA #202102		 ORIG-1 ARIPIPRAZOLE ALEMBIC Approval
04/28/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203072		 SUPPL-1 HYDROCHLOROTHIAZIDE; IRBESARTAN PRINSTON INC Labeling Approval
04/28/2015 ARIPIPRAZOLE
ANDA #205064		 ORIG-1 ARIPIPRAZOLE HETERO LABS LTD V Approval
04/29/2015 ULTRAVATE
NDA #019967		 SUPPL-16 HALOBETASOL PROPIONATE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/29/2015 ARAVA
NDA #020905		 SUPPL-26 LEFLUNOMIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
04/29/2015 CARAC
NDA #020985		 SUPPL-17 FLUOROURACIL VALEANT PHARMS NORTH Manufacturing (CMC) Approval
04/29/2015 PHOSLO
NDA #021160		 SUPPL-27 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/29/2015 PHOSLO GELCAPS
NDA #021160		 SUPPL-27 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/29/2015 NAMENDA
NDA #021487		 SUPPL-20 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
04/29/2015 ATROVENT HFA
NDA #021527		 SUPPL-22 IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/29/2015 GONAL-F
BLA #021765		 SUPPL-39 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/29/2015 GONAL-F RFF
BLA #021765		 SUPPL-39 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/29/2015 BYDUREON
NDA #022200		 SUPPL-10 EXENATIDE SYNTHETIC ASTRAZENECA AB REMS Approval
04/29/2015 BYDUREON PEN
NDA #022200		 SUPPL-10 EXENATIDE SYNTHETIC ASTRAZENECA AB REMS Approval
04/29/2015 DISOPYRAMIDE PHOSPHATE
ANDA #070101		 SUPPL-46 DISOPYRAMIDE PHOSPHATE TEVA Labeling Approval
04/29/2015 DISOPYRAMIDE PHOSPHATE
ANDA #070102		 SUPPL-51 DISOPYRAMIDE PHOSPHATE TEVA Labeling Approval
04/29/2015 ATENOLOL
ANDA #073475		 SUPPL-37 ATENOLOL SUN PHARM INDUSTRIES Labeling Approval
04/29/2015 ATENOLOL
ANDA #073476		 SUPPL-35 ATENOLOL SUN PHARM INDUSTRIES Labeling Approval
04/29/2015 GEMFIBROZIL
ANDA #074256		 SUPPL-38 GEMFIBROZIL TEVA Labeling Approval
04/29/2015 GEMFIBROZIL
ANDA #074256		 SUPPL-39 GEMFIBROZIL TEVA Labeling Approval
04/29/2015 MEXILETINE HYDROCHLORIDE
ANDA #074450		 SUPPL-14 MEXILETINE HYDROCHLORIDE ANI PHARMS Labeling Approval
04/29/2015 ATENOLOL
ANDA #074499		 SUPPL-34 ATENOLOL SUN PHARM INDUSTRIES Labeling Approval
04/29/2015 BUSPIRONE HYDROCHLORIDE
ANDA #075022		 SUPPL-13 BUSPIRONE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/29/2015 LOXAPINE SUCCINATE
ANDA #076868		 SUPPL-8 LOXAPINE SUCCINATE ELITE LABS INC Labeling Approval
04/29/2015 OLANZAPINE
ANDA #077301		 ORIG-1 OLANZAPINE IVAX PHARMS INC Approval
04/29/2015 EPOPROSTENOL SODIUM
ANDA #078396		 SUPPL-10 EPOPROSTENOL SODIUM MEITHEAL Labeling Approval
04/29/2015 SULFACETAMIDE SODIUM
ANDA #078649		 SUPPL-2 SULFACETAMIDE SODIUM PADAGIS US Labeling Approval
04/29/2015 TROSPIUM CHLORIDE
ANDA #091635		 ORIG-1 TROSPIUM CHLORIDE UPSHER SMITH LABS Approval
04/29/2015 TACROLIMUS
ANDA #200744		 SUPPL-1 TACROLIMUS FOUGERA PHARMS INC Manufacturing (CMC) Approval
04/29/2015 OXYCODONE HYDROCHLORIDE
ANDA #204603		 ORIG-1 OXYCODONE HYDROCHLORIDE NOVEL LABS INC Approval
04/29/2015 FESOTERODINE FUMARATE
ANDA #204893		 ORIG-1 FESOTERODINE FUMARATE LUPIN LTD Tentative Approval
04/29/2015 AKYNZEO
NDA #205718		 SUPPL-2 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
04/29/2015 KYBELLA
NDA #206333		 ORIG-1 DEOXYCHOLIC ACID ABBVIE Type 1 - New Molecular Entity Approval
04/30/2015 DILANTIN-125
NDA #008762		 SUPPL-53 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
04/30/2015 DILANTIN-30
NDA #008762		 SUPPL-53 PHENYTOIN VIATRIS Manufacturing (CMC) Approval
04/30/2015 SILVADENE
NDA #017381		 SUPPL-52 SILVER SULFADIAZINE KING PHARMS LLC Manufacturing (CMC) Approval
04/30/2015 ANDRODERM
NDA #020489		 SUPPL-32 TESTOSTERONE ABBVIE Manufacturing (CMC) Approval
04/30/2015 IONSYS
NDA #021338		 SUPPL-5 FENTANYL HYDROCHLORIDE THE MEDICINES CO Efficacy Approval
04/30/2015 RELISTOR
NDA #021964		 SUPPL-12 METHYLNALTREXONE BROMIDE SALIX PHARMS Manufacturing (CMC) Approval
04/30/2015 PHOSLYRA
NDA #022581		 SUPPL-6 CALCIUM ACETATE FRESENIUS MEDCL Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #074507		 SUPPL-55 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #074707		 SUPPL-50 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #076568		 SUPPL-27 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #076569		 SUPPL-23 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 KIMIDESS
ANDA #076681		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL VINTAGE PHARMS Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #078697		 SUPPL-11 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #078699		 SUPPL-11 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #079038		 SUPPL-10 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #079044		 SUPPL-10 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #079216		 SUPPL-12 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 NICOTINE POLACRILEX
ANDA #079219		 SUPPL-12 NICOTINE POLACRILEX P AND L Labeling Approval
04/30/2015 MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
NDA #202106		 ORIG-1 MEROPENEM B BRAUN MEDICAL INC Type 4 - New Combination Approval
04/30/2015 BREO ELLIPTA
NDA #204275		 SUPPL-1 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Efficacy Approval
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