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 |