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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 November 08, 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 XIROMED 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 NORVIUM BIOSCIENCE Labeling Approval
04/03/2015 RABEPRAZOLE SODIUM
ANDA #076885
SUPPL-3 RABEPRAZOLE SODIUM NORVIUM BIOSCIENCE 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 ENDO OPERATIONS 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 NORVIUM BIOSCIENCE Labeling Approval
04/09/2015 AZITHROMYCIN
ANDA #065366
SUPPL-8 AZITHROMYCIN RISING Labeling Approval
04/09/2015 MINOXIDIL
ANDA #071826
SUPPL-9 MINOXIDIL ENDO OPERATIONS Manufacturing (CMC) Approval
04/09/2015 MINOXIDIL
ANDA #071826
SUPPL-11 MINOXIDIL ENDO OPERATIONS 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 ENDO OPERATIONS 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 DIFGEN PHARMS 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 ENDO OPERATIONS 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 ENDO OPERATIONS 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 NUVO PHARM 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 NATCO Labeling Approval
04/16/2015 ZONTIVITY
NDA #204886
SUPPL-2 VORAPAXAR SULFATE KEY THERAP 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 SPANSULE
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 RISING 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 OPERATIONS 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 XIROMED 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 NORVIUM BIOSCIENCE 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 KEY THERAP 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 NORVIUM BIOSCIENCE Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093
SUPPL-11 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE NORVIUM BIOSCIENCE Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093
SUPPL-13 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE NORVIUM BIOSCIENCE Labeling Approval
04/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093
SUPPL-14 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE NORVIUM BIOSCIENCE 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 ENDO OPERATIONS 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
04/30/2015 OPSUMIT
NDA #204410
SUPPL-3 MACITENTAN ACTELION Labeling Approval
04/30/2015 BELSOMRA
NDA #204569
SUPPL-2 SUVOREXANT MERCK SHARP DOHME Manufacturing (CMC) Approval
04/30/2015 TUZISTRA XR
NDA #207768
ORIG-1 CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX TRIS PHARMA INC Type 3 - New Dosage Form Approval
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