06/01/2018 |
NOVOLIN R BLA #019938 |
SUPPL-76 |
INSULIN RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
06/01/2018 |
NOVOLIN N BLA #019959 |
SUPPL-74 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
06/01/2018 |
NOVOLIN N BLA #019959 |
SUPPL-79 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
06/01/2018 |
NOVOLIN 70/30 BLA #019991 |
SUPPL-75 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
06/01/2018 |
NOVOLIN 70/30 BLA #019991 |
SUPPL-79 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
06/01/2018 |
CHANTIX NDA #021928 |
SUPPL-45 |
VARENICLINE TARTRATE |
PF PRISM CV |
Efficacy |
Approval |
06/01/2018 |
CHANTIX NDA #021928 |
SUPPL-46 |
VARENICLINE TARTRATE |
PF PRISM CV |
Efficacy |
Approval |
06/01/2018 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #065443 |
SUPPL-13 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
MYLAN PHARMS INC |
Manufacturing (CMC) |
Approval |
06/01/2018 |
LORATADINE ANDA #075728 |
SUPPL-15 |
LORATADINE |
PERRIGO |
Manufacturing (CMC) |
Approval |
06/01/2018 |
BIVALIRUDIN ANDA #202471 |
ORIG-1 |
BIVALIRUDIN |
MYLAN INSTITUTIONAL |
|
Approval |
06/01/2018 |
MORPHABOND ER NDA #206544 |
SUPPL-7 |
MORPHINE SULFATE |
OHEMO LIFE |
Labeling |
Approval |
06/01/2018 |
NADOLOL ANDA #210786 |
ORIG-1 |
NADOLOL |
NOVAST LABS |
|
Approval |
06/04/2018 |
ALIMTA NDA #021462 |
SUPPL-51 |
PEMETREXED DISODIUM |
LILLY |
Efficacy |
Approval |
06/04/2018 |
CLARITIN NDA #021952 |
SUPPL-15 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
06/04/2018 |
SUPRAX ANDA #065129 |
SUPPL-32 |
CEFIXIME |
LUPIN PHARMS |
Manufacturing (CMC) |
Approval |
06/04/2018 |
JUXTAPID NDA #203858 |
SUPPL-18 |
LOMITAPIDE MESYLATE |
CHIESI |
REMS |
Approval |
06/04/2018 |
PREZCOBIX NDA #205395 |
SUPPL-9 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Efficacy |
Approval |
06/04/2018 |
SUCCINYLCHOLINE CHLORIDE ANDA #210231 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
AMRING PHARMS |
|
Approval |
06/04/2018 |
FLUOCINONIDE ANDA #211111 |
ORIG-1 |
FLUOCINONIDE |
AMNEAL |
|
Approval |
06/04/2018 |
FULPHILA BLA #761075 |
ORIG-1 |
PEGFILGRASTIM-JMDB |
MYLAN GMBH |
|
Approval |
06/05/2018 |
NICORETTE NDA #018612 |
SUPPL-80 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
06/05/2018 |
NICORETTE (MINT) NDA #018612 |
SUPPL-80 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
06/05/2018 |
NICORETTE NDA #020066 |
SUPPL-61 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
06/05/2018 |
NICORETTE (MINT) NDA #020066 |
SUPPL-61 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
06/05/2018 |
NICORETTE NDA #022360 |
SUPPL-11 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
06/05/2018 |
MERREM NDA #050706 |
SUPPL-40 |
MEROPENEM |
PFIZER |
Labeling |
Approval |
06/05/2018 |
OMEPRAZOLE ANDA #075785 |
SUPPL-8 |
OMEPRAZOLE |
IMPAX LABS |
Labeling |
Approval |
06/05/2018 |
ERBITUX BLA #125084 |
SUPPL-269 |
CETUXIMAB |
IMCLONE |
|
Approval |
06/05/2018 |
DAPTOMYCIN ANDA #205037 |
ORIG-1 |
DAPTOMYCIN |
MYLAN LABS LTD |
|
Approval |
06/05/2018 |
ALECENSA NDA #208434 |
SUPPL-4 |
ALECTINIB HYDROCHLORIDE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
06/05/2018 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #208683 |
ORIG-1 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
TARO |
|
Approval |
06/05/2018 |
HAILEY FE 1.5/30 ANDA #209031 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
GLENMARK PHARMS |
|
Approval |
06/05/2018 |
HAILEY 1.5/30 ANDA #209297 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
GLENMARK PHARMS |
|
Approval |
06/06/2018 |
PRED FORTE NDA #017011 |
SUPPL-50 |
PREDNISOLONE ACETATE |
ABBVIE |
Labeling |
Approval |
06/06/2018 |
PRED MILD NDA #017100 |
SUPPL-45 |
PREDNISOLONE ACETATE |
ABBVIE |
Labeling |
Approval |
06/06/2018 |
COLISTIMETHATE SODIUM ANDA #064216 |
SUPPL-15 |
COLISTIMETHATE SODIUM |
XGEN PHARMS |
Manufacturing (CMC) |
Approval |
06/06/2018 |
XIAFLEX BLA #125338 |
SUPPL-109 |
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM |
AUXILIUM PHARMS |
|
Approval |
06/06/2018 |
OMEPRAZOLE MAGNESIUM ANDA #206877 |
ORIG-1 |
OMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA |
|
Approval |
06/06/2018 |
LENVIMA NDA #206947 |
SUPPL-8 |
LENVATINIB MESYLATE |
EISAI INC |
Labeling |
Approval |
06/06/2018 |
NUPLAZID NDA #207318 |
SUPPL-5 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
06/06/2018 |
AUSTEDO NDA #208082 |
SUPPL-2 |
DEUTETRABENAZINE |
TEVA BRANDED PHARM |
Labeling |
Approval |
06/07/2018 |
PREVACID NDA #020406 |
SUPPL-87 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
PREVACID NDA #020406 |
SUPPL-88 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
ACIPHEX NDA #020973 |
SUPPL-39 |
RABEPRAZOLE SODIUM |
WOODWARD |
Labeling |
Approval |
06/07/2018 |
PROTONIX NDA #020987 |
SUPPL-54 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
06/07/2018 |
PROTONIX IV NDA #020988 |
SUPPL-60 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
06/07/2018 |
NEXIUM NDA #021153 |
SUPPL-53 |
ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
06/07/2018 |
PREVACID NDA #021428 |
SUPPL-34 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
PREVACID NDA #021428 |
SUPPL-35 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
ZEGERID NDA #021636 |
SUPPL-19 |
OMEPRAZOLE; SODIUM BICARBONATE |
SALIX |
Labeling |
Approval |
06/07/2018 |
ZEGERID NDA #021849 |
SUPPL-14 |
OMEPRAZOLE; SODIUM BICARBONATE |
SALIX |
Labeling |
Approval |
06/07/2018 |
NEXIUM NDA #021957 |
SUPPL-20 |
ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
06/07/2018 |
PROTONIX NDA #022020 |
SUPPL-16 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
06/07/2018 |
PRILOSEC NDA #022056 |
SUPPL-22 |
OMEPRAZOLE MAGNESIUM |
COVIS |
Labeling |
Approval |
06/07/2018 |
NEXIUM NDA #022101 |
SUPPL-17 |
ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
06/07/2018 |
DEXILANT NDA #022287 |
SUPPL-29 |
DEXLANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
DEXILANT NDA #022287 |
SUPPL-30 |
DEXLANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
VIMOVO NDA #022511 |
SUPPL-23 |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
HORIZON |
Labeling |
Approval |
06/07/2018 |
PRED-G NDA #050586 |
SUPPL-32 |
GENTAMICIN SULFATE; PREDNISOLONE ACETATE |
ALLERGAN |
Labeling |
Approval |
06/07/2018 |
PRED-G NDA #050612 |
SUPPL-21 |
GENTAMICIN SULFATE; PREDNISOLONE ACETATE |
ALLERGAN |
Labeling |
Approval |
06/07/2018 |
PREVPAC (COPACKAGED) NDA #050757 |
SUPPL-22 |
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075347 |
SUPPL-24 |
OMEPRAZOLE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075410 |
SUPPL-57 |
OMEPRAZOLE |
LANNETT CO INC |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075576 |
SUPPL-19 |
OMEPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075757 |
SUPPL-49 |
OMEPRAZOLE |
SANDOZ |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075785 |
SUPPL-10 |
OMEPRAZOLE |
IMPAX LABS |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #075876 |
SUPPL-41 |
OMEPRAZOLE |
STRIDES PHARMA |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #076048 |
SUPPL-21 |
OMEPRAZOLE |
APOTEX |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #076515 |
SUPPL-29 |
OMEPRAZOLE |
SANDOZ |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #078490 |
SUPPL-14 |
OMEPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
06/07/2018 |
ATORVASTATIN CALCIUM ANDA #090548 |
SUPPL-16 |
ATORVASTATIN CALCIUM |
APOTEX INC |
Labeling |
Approval |
06/07/2018 |
ATORVASTATIN CALCIUM ANDA #090548 |
SUPPL-17 |
ATORVASTATIN CALCIUM |
APOTEX INC |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #091352 |
SUPPL-12 |
OMEPRAZOLE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #091672 |
SUPPL-13 |
OMEPRAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/07/2018 |
RITUXAN BLA #103705 |
SUPPL-5450 |
RITUXIMAB |
GENENTECH |
|
Approval |
06/07/2018 |
KINERET BLA #103950 |
SUPPL-5182 |
ANAKINRA |
BIOVITRUM AB |
|
Approval |
06/07/2018 |
MIRCERA BLA #125164 |
SUPPL-78 |
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
HOFFMAN-LA ROCHE |
|
Approval |
06/07/2018 |
PROLIA BLA #125320 |
SUPPL-191 |
DENOSUMAB |
AMGEN |
|
Approval |
06/07/2018 |
XGEVA BLA #125320 |
SUPPL-191 |
DENOSUMAB |
AMGEN |
|
Approval |
06/07/2018 |
ESOMEPRAZOLE STRONTIUM NDA #202342 |
SUPPL-5 |
ESOMEPRAZOLE STRONTIUM |
BELCHER |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #202384 |
SUPPL-2 |
OMEPRAZOLE |
LUPIN LTD |
Labeling |
Approval |
06/07/2018 |
KYPROLIS NDA #202714 |
SUPPL-19 |
CARFILZOMIB |
ONYX PHARMS AMGEN |
Efficacy |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #203270 |
SUPPL-8 |
OMEPRAZOLE |
AUROBINDO PHARMA |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #203481 |
SUPPL-1 |
OMEPRAZOLE |
BRECKENRIDGE |
Labeling |
Approval |
06/07/2018 |
OMEPRAZOLE ANDA #204661 |
SUPPL-2 |
OMEPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
06/07/2018 |
ACIPHEX SPRINKLE NDA #204736 |
SUPPL-10 |
RABEPRAZOLE SODIUM |
AYTU |
Labeling |
Approval |
06/07/2018 |
YOSPRALA NDA #205103 |
SUPPL-4 |
ASPIRIN; OMEPRAZOLE |
GENUS LIFESCIENCES |
Labeling |
Approval |
06/07/2018 |
ETODOLAC ANDA #208834 |
ORIG-1 |
ETODOLAC |
AMNEAL PHARMS CO |
|
Approval |
06/08/2018 |
ALEVE NDA #020204 |
SUPPL-55 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
06/08/2018 |
GEMZAR NDA #020509 |
SUPPL-80 |
GEMCITABINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
06/08/2018 |
REMODULIN NDA #021272 |
SUPPL-26 |
TREPROSTINIL |
UNITED THERAP |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #075689 |
SUPPL-20 |
HALOPERIDOL LACTATE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #075858 |
SUPPL-20 |
HALOPERIDOL LACTATE |
HIKMA |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #075858 |
SUPPL-21 |
HALOPERIDOL LACTATE |
HIKMA |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #076035 |
SUPPL-23 |
HALOPERIDOL LACTATE |
TEVA PHARMS USA |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #076035 |
SUPPL-24 |
HALOPERIDOL LACTATE |
TEVA PHARMS USA |
Labeling |
Approval |
06/08/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #076240 |
SUPPL-13 |
QUINAPRIL HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
06/08/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #076240 |
SUPPL-14 |
QUINAPRIL HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #076774 |
SUPPL-4 |
HALOPERIDOL LACTATE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #076774 |
SUPPL-5 |
HALOPERIDOL LACTATE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #076774 |
SUPPL-7 |
HALOPERIDOL LACTATE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #078347 |
SUPPL-7 |
HALOPERIDOL LACTATE |
MYLAN LABS LTD |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #078347 |
SUPPL-8 |
HALOPERIDOL LACTATE |
MYLAN LABS LTD |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #078347 |
SUPPL-11 |
HALOPERIDOL LACTATE |
MYLAN LABS LTD |
Labeling |
Approval |
06/08/2018 |
SECONAL SODIUM ANDA #086101 |
SUPPL-23 |
SECOBARBITAL SODIUM |
VALEANT PHARMS NORTH |
Labeling |
Approval |
06/08/2018 |
PROMETH VC W/ CODEINE ANDA #088764 |
SUPPL-87 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #091637 |
SUPPL-3 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #091637 |
SUPPL-4 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #091637 |
SUPPL-5 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
06/08/2018 |
BETASERON BLA #103471 |
SUPPL-5191 |
INTERFERON BETA-1B |
BAYER HEALTHCARE PHARMS |
|
Approval |
06/08/2018 |
STELARA BLA #125261 |
SUPPL-147 |
USTEKINUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
06/08/2018 |
HALOPERIDOL ANDA #200742 |
SUPPL-3 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
06/08/2018 |
HALOPERIDOL ANDA #200742 |
SUPPL-4 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
06/08/2018 |
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #200963 |
SUPPL-3 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/08/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #202725 |
SUPPL-7 |
QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/08/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #202725 |
SUPPL-8 |
QUINAPRIL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/08/2018 |
BUPROPION HYDROCHLORIDE ANDA #203013 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
ALEMBIC |
|
Approval |
06/08/2018 |
GATIFLOXACIN ANDA #206446 |
ORIG-1 |
GATIFLOXACIN |
RISING |
|
Approval |
06/08/2018 |
ESMOLOL HYDROCHLORIDE ANDA #206608 |
ORIG-1 |
ESMOLOL HYDROCHLORIDE |
MYLAN LABS LTD |
|
Approval |
06/08/2018 |
ESMOLOL HYDROCHLORIDE ANDA #207107 |
ORIG-1 |
ESMOLOL HYDROCHLORIDE |
SAGENT PHARMS INC |
|
Approval |
06/08/2018 |
DEXAMETHASONE SODIUM PHOSPHATE ANDA #207521 |
ORIG-1 |
DEXAMETHASONE SODIUM PHOSPHATE |
SOMERSET |
|
Approval |
06/08/2018 |
VENCLEXTA NDA #208573 |
SUPPL-4 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
06/08/2018 |
VENCLEXTA NDA #208573 |
SUPPL-5 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
06/08/2018 |
OSELTAMIVIR PHOSPHATE ANDA #209421 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
STRIDES PHARMA |
|
Approval |
06/11/2018 |
ALEVE NDA #020204 |
SUPPL-56 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
06/11/2018 |
SUBUTEX NDA #020732 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
06/11/2018 |
SUBOXONE NDA #020733 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
06/11/2018 |
SUBOXONE NDA #022410 |
SUPPL-33 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
06/11/2018 |
AZITHROMYCIN ANDA #065360 |
SUPPL-8 |
AZITHROMYCIN |
AUROBINDO PHARMA USA |
Labeling |
Approval |
06/11/2018 |
CEFTRIAXONE ANDA #091049 |
ORIG-1 |
CEFTRIAXONE SODIUM |
ASTRAL |
|
Approval |
06/11/2018 |
SILDENAFIL CITRATE ANDA #091448 |
ORIG-1 |
SILDENAFIL CITRATE |
TORRENT |
|
Approval |
06/11/2018 |
SILDENAFIL CITRATE ANDA #202659 |
ORIG-1 |
SILDENAFIL CITRATE |
HETERO LABS LTD V |
|
Approval |
06/11/2018 |
SILDENAFIL CITRATE ANDA #203962 |
ORIG-1 |
SILDENAFIL CITRATE |
AUROBINDO PHARMA LTD |
|
Approval |
06/11/2018 |
SILDENAFIL CITRATE ANDA #204882 |
ORIG-1 |
SILDENAFIL CITRATE |
RUBICON |
|
Approval |
06/11/2018 |
ROPIVACAINE HYDROCHLORIDE ANDA #206166 |
ORIG-1 |
ROPIVACAINE HYDROCHLORIDE |
INFORLIFE |
|
Approval |
06/11/2018 |
LACTULOSE ANDA #207786 |
ORIG-1 |
LACTULOSE |
APOZEAL PHARMS |
|
Approval |
06/11/2018 |
VYZULTA NDA #207795 |
SUPPL-2 |
LATANOPROSTENE BUNOD |
BAUSCH AND LOMB |
Labeling |
Approval |
06/12/2018 |
PRILOSEC OTC NDA #021229 |
SUPPL-32 |
OMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
06/12/2018 |
KEYTRUDA BLA #125514 |
SUPPL-34 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
06/12/2018 |
GLEOLAN NDA #208630 |
SUPPL-2 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
NXDC |
Labeling |
Approval |
06/12/2018 |
PAROXETINE HYDROCHLORIDE ANDA #209293 |
ORIG-1 |
PAROXETINE HYDROCHLORIDE |
SCIECURE PHARMA INC |
|
Approval |
06/12/2018 |
OMEPRAZOLE NDA #209400 |
SUPPL-2 |
OMEPRAZOLE |
DEXCEL |
Labeling |
Approval |
06/12/2018 |
ISOPROTERENOL HYDROCHLORIDE ANDA #210322 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
CIPLA |
|
Approval |
06/12/2018 |
DIFLORASONE DIACETATE ANDA #210753 |
ORIG-1 |
DIFLORASONE DIACETATE |
THE J MOLNER |
|
Approval |
06/13/2018 |
AVASTIN BLA #125085 |
SUPPL-323 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
06/13/2018 |
KEYTRUDA BLA #125514 |
SUPPL-30 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
06/13/2018 |
CONTRAVE NDA #200063 |
SUPPL-13 |
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE |
NALPROPION |
Labeling |
Approval |
06/13/2018 |
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM ANDA #205947 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM |
LUPIN LTD |
|
Approval |
06/13/2018 |
DOXYCYCLINE HYCLATE ANDA #210527 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
ALEMBIC |
|
Approval |
06/13/2018 |
MOXIDECTIN NDA #210867 |
ORIG-1 |
MOXIDECTIN |
MDGH |
Type 1 - New Molecular Entity |
Approval |
06/14/2018 |
CIMZIA BLA #125160 |
SUPPL-279 |
CERTOLIZUMAB PEGOL |
UCB INC |
|
Approval |
06/14/2018 |
STIVARGA NDA #203085 |
SUPPL-8 |
REGORAFENIB |
BAYER HLTHCARE |
Efficacy |
Approval |
06/14/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205299 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
|
Approval |
06/14/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205806 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
|
Approval |
06/14/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207607 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
MYLAN TECHNOLOGIES |
|
Approval |
06/14/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207607 |
ORIG-2 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
MYLAN TECHNOLOGIES |
|
Approval |
06/14/2018 |
BUPROPION HYDROCHLORIDE ANDA #210015 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
YICHANG HUMANWELL |
|
Approval |
06/14/2018 |
TECENTRIQ BLA #761034 |
SUPPL-8 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
06/15/2018 |
DESOGEN NDA #020071 |
SUPPL-23 |
DESOGESTREL; ETHINYL ESTRADIOL |
ORGANON USA INC |
Labeling |
Approval |
06/15/2018 |
ISENTRESS NDA #022145 |
SUPPL-39 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Labeling |
Approval |
06/15/2018 |
ISENTRESS HD NDA #022145 |
SUPPL-39 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Labeling |
Approval |
06/15/2018 |
ONFI NDA #202067 |
SUPPL-5 |
CLOBAZAM |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
06/15/2018 |
ONFI NDA #203993 |
SUPPL-7 |
CLOBAZAM |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
06/15/2018 |
BENDAMUSTINE HYDROCHLORIDE ANDA #204086 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
HOSPIRA INC |
|
Tentative Approval |
06/15/2018 |
EFAVIRENZ ANDA #204766 |
ORIG-1 |
EFAVIRENZ |
CIPLA |
|
Approval |
06/15/2018 |
BENDAMUSTINE HYDROCHLORIDE ANDA #205476 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
INNOPHARMA LICENSING |
|
Tentative Approval |
06/15/2018 |
ROPIVACAINE HYDROCHLORIDE ANDA #207636 |
ORIG-1 |
ROPIVACAINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
06/15/2018 |
ANDA #209831 |
ORIG-1 |
|
TEVA PHARMS USA |
|
Tentative Approval |
06/15/2018 |
BUPRENORPHINE; NALOXONE ANDA #209831 |
ORIG-1 |
BUPRENORPHINE; NALOXONE |
TEVA PHARMS USA |
|
Tentative Approval |
06/15/2018 |
LYMEPAK NDA #209844 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
CHARTWELL PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/15/2018 |
CLOBETASOL PROPIONATE ANDA #210034 |
ORIG-1 |
CLOBETASOL PROPIONATE |
XIROMED |
|
Approval |
06/15/2018 |
NEOSTIGMINE METHYLSULFATE ANDA #210051 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
AMNEAL |
|
Approval |
06/18/2018 |
DICLEGIS NDA #021876 |
SUPPL-13 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
DUCHESNAY |
Labeling |
Approval |
06/18/2018 |
ARGATROBAN IN SODIUM CHLORIDE NDA #022434 |
SUPPL-11 |
ARGATROBAN |
CIPLA |
Labeling |
Approval |
06/18/2018 |
CEFOBID NDA #050551 |
SUPPL-44 |
CEFOPERAZONE SODIUM |
PFIZER |
Labeling |
Approval |
06/18/2018 |
AZACTAM NDA #050580 |
SUPPL-44 |
AZTREONAM |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
06/18/2018 |
AZACTAM IN PLASTIC CONTAINER NDA #050632 |
SUPPL-19 |
AZTREONAM |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
06/18/2018 |
LEVORPHANOL TARTRATE ANDA #074278 |
SUPPL-11 |
LEVORPHANOL TARTRATE |
HIKMA |
|
Approval |
06/18/2018 |
NEUPOGEN BLA #103353 |
SUPPL-5194 |
FILGRASTIM |
AMGEN |
|
Approval |
06/18/2018 |
NEULASTA BLA #125031 |
SUPPL-193 |
PEGFILGRASTIM |
AMGEN |
|
Approval |
06/18/2018 |
NATEGLINIDE ANDA #205544 |
ORIG-1 |
NATEGLINIDE |
RISING |
|
Approval |
06/18/2018 |
FLUCYTOSINE ANDA #207536 |
ORIG-1 |
FLUCYTOSINE |
STRIDES PHARMA |
|
Approval |
06/18/2018 |
BONJESTA NDA #209661 |
SUPPL-4 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
DUCHESNAY |
Labeling |
Approval |
06/18/2018 |
ATORVASTATIN CALCIUM ANDA #209912 |
ORIG-1 |
ATORVASTATIN CALCIUM |
GRAVITI PHARMS |
|
Approval |
06/18/2018 |
ISOPROTERENOL HYDROCHLORIDE ANDA #210106 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
AMPHASTAR PHARMS INC |
|
Approval |
06/18/2018 |
KETOCONAZOLE ANDA #210457 |
ORIG-1 |
KETOCONAZOLE |
STRIDES PHARMA |
|
Approval |
06/18/2018 |
VERAPAMIL HYDROCHLORIDE ANDA #211015 |
ORIG-1 |
VERAPAMIL HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
06/18/2018 |
VERAPAMIL HYDROCHLORIDE ANDA #211035 |
ORIG-1 |
VERAPAMIL HYDROCHLORIDE |
SOMERSET |
|
Approval |
06/18/2018 |
DARZALEX BLA #761036 |
SUPPL-14 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
06/19/2018 |
TOPAMAX NDA #020505 |
SUPPL-58 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
06/19/2018 |
TOPAMAX NDA #020844 |
SUPPL-49 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
06/19/2018 |
TOPAMAX SPRINKLE NDA #020844 |
SUPPL-49 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
06/19/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #040151 |
SUPPL-19 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/19/2018 |
PROMETHAZINE WITH CODEINE ANDA #040650 |
SUPPL-22 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/19/2018 |
M-ZOLE 3 COMBINATION PACK ANDA #074926 |
SUPPL-18 |
MICONAZOLE NITRATE |
P AND L |
Labeling |
Approval |
06/19/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #088763 |
SUPPL-88 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
06/19/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #089647 |
SUPPL-14 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/19/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #089647 |
SUPPL-15 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/19/2018 |
REMICADE BLA #103772 |
SUPPL-5385 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
06/19/2018 |
COSENTYX BLA #125504 |
SUPPL-5 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
06/19/2018 |
KEYTRUDA BLA #125514 |
SUPPL-43 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
06/19/2018 |
PRASUGREL ANDA #205913 |
ORIG-1 |
PRASUGREL HYDROCHLORIDE |
AMNEAL PHARMS |
|
Approval |
06/19/2018 |
FLUOCINONIDE ANDA #209030 |
ORIG-1 |
FLUOCINONIDE |
PADAGIS US |
|
Approval |
06/19/2018 |
TESTOSTERONE CYPIONATE ANDA #210362 |
ORIG-1 |
TESTOSTERONE CYPIONATE |
CIPLA |
|
Approval |
06/19/2018 |
TECENTRIQ BLA #761034 |
SUPPL-10 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
06/20/2018 |
EXTINA NDA #021738 |
SUPPL-7 |
KETOCONAZOLE |
MYLAN |
Labeling |
Approval |
06/20/2018 |
CLARITIN NDA #021952 |
SUPPL-16 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
06/20/2018 |
RIVASTIGMINE ANDA #205622 |
ORIG-1 |
RIVASTIGMINE |
MYLAN TECHNOLOGIES |
|
Approval |
06/20/2018 |
TYMLOS NDA #208743 |
SUPPL-4 |
ABALOPARATIDE |
RADIUS |
Labeling |
Approval |
06/20/2018 |
LABETALOL HYDROCHLORIDE ANDA #209603 |
ORIG-1 |
LABETALOL HYDROCHLORIDE |
APPCO |
|
Approval |
06/21/2018 |
PEPCID NDA #019462 |
SUPPL-39 |
FAMOTIDINE |
BAUSCH |
Labeling |
Approval |
06/21/2018 |
ULTIVA NDA #020630 |
SUPPL-18 |
REMIFENTANIL HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
06/21/2018 |
RELENZA NDA #021036 |
SUPPL-30 |
ZANAMIVIR |
GLAXOSMITHKLINE |
Labeling |
Approval |
06/21/2018 |
NOCDURNA NDA #022517 |
ORIG-1 |
DESMOPRESSIN ACETATE |
FERRING PHARMS INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/21/2018 |
ABLYSINOL NDA #207987 |
ORIG-1 |
ALCOHOL |
BPI LABS |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/21/2018 |
RYDAPT NDA #207997 |
SUPPL-2 |
MIDOSTAURIN |
NOVARTIS |
Labeling |
Approval |
06/21/2018 |
VIGADRONE ANDA #210196 |
ORIG-1 |
VIGABATRIN |
AUCTA |
|
Approval |
06/22/2018 |
KENALOG-10 NDA #012041 |
SUPPL-45 |
TRIAMCINOLONE ACETONIDE |
APOTHECON |
Labeling |
Approval |
06/22/2018 |
KENALOG-40 NDA #014901 |
SUPPL-45 |
TRIAMCINOLONE ACETONIDE |
APOTHECON |
Labeling |
Approval |
06/22/2018 |
KENALOG-80 NDA #014901 |
SUPPL-45 |
TRIAMCINOLONE ACETONIDE |
APOTHECON |
Labeling |
Approval |
06/22/2018 |
NAVELBINE NDA #020388 |
SUPPL-35 |
VINORELBINE TARTRATE |
PIERRE FABRE |
Labeling |
Approval |
06/22/2018 |
NASONEX NDA #020762 |
SUPPL-52 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
06/22/2018 |
NASONEX NDA #020762 |
SUPPL-53 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
06/22/2018 |
BARACLUDE NDA #021797 |
SUPPL-19 |
ENTECAVIR |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
06/22/2018 |
BARACLUDE NDA #021798 |
SUPPL-21 |
ENTECAVIR |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
06/22/2018 |
APTIVUS NDA #021814 |
SUPPL-18 |
TIPRANAVIR |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
06/22/2018 |
APTIVUS NDA #022292 |
SUPPL-10 |
TIPRANAVIR |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
06/22/2018 |
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #040674 |
SUPPL-6 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/22/2018 |
MELOXICAM ANDA #077920 |
SUPPL-4 |
MELOXICAM |
SCIEGEN PHARMS INC |
Manufacturing (CMC) |
Approval |
06/22/2018 |
BENLYSTA BLA #125370 |
SUPPL-62 |
BELIMUMAB |
HUMAN GENOME SCIENCES INC. |
|
Approval |
06/22/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #200894 |
SUPPL-3 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/22/2018 |
ARGATROBAN IN DEXTROSE NDA #201743 |
SUPPL-2 |
ARGATROBAN |
SANDOZ |
Labeling |
Approval |
06/22/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #205069 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
MYLAN |
|
Approval |
06/22/2018 |
OXYCODONE HYDROCHLORIDE ANDA #207511 |
SUPPL-2 |
OXYCODONE HYDROCHLORIDE |
WES PHARMA INC |
Manufacturing (CMC) |
Approval |
06/22/2018 |
DUTASTERIDE ANDA #208227 |
ORIG-1 |
DUTASTERIDE |
STRIDES PHARMA |
|
Approval |
06/22/2018 |
RIVAROXABAN ANDA #208544 |
ORIG-1 |
RIVAROXABAN |
AUROBINDO PHARMA |
|
Tentative Approval |
06/22/2018 |
CIPROFLOXACIN HYDROCHLORIDE ANDA #208921 |
ORIG-1 |
CIPROFLOXACIN HYDROCHLORIDE |
YILING |
|
Approval |
06/22/2018 |
POTASSIUM CHLORIDE ANDA #209314 |
ORIG-1 |
POTASSIUM CHLORIDE |
YICHANG HUMANWELL |
|
Approval |
06/22/2018 |
BENLYSTA BLA #761043 |
SUPPL-2 |
BELIMUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
06/25/2018 |
ATAZANAVIR SULFATE ANDA #204806 |
ORIG-1 |
ATAZANAVIR SULFATE |
AUROBINDO PHARMA |
|
Approval |
06/25/2018 |
ERTAPENEM SODIUM ANDA #209133 |
ORIG-1 |
ERTAPENEM SODIUM |
EUGIA PHARMA |
|
Approval |
06/25/2018 |
ZEMDRI NDA #210303 |
ORIG-1 |
PLAZOMICIN SULFATE |
CIPLA USA |
Type 1 - New Molecular Entity |
Approval |
06/25/2018 |
EPIDIOLEX NDA #210365 |
ORIG-1 |
CANNABIDIOL |
JAZZ PHARMS RES |
Type 1 - New Molecular Entity |
Approval |
06/26/2018 |
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #040660 |
SUPPL-22 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/26/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #200386 |
SUPPL-5 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
TRIS PHARMA INC |
Labeling |
Approval |
06/26/2018 |
MESALAMINE ANDA #203286 |
SUPPL-1 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
06/26/2018 |
MESALAMINE ANDA #203286 |
SUPPL-2 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
06/26/2018 |
SUMATRIPTAN ANDA #204841 |
SUPPL-8 |
SUMATRIPTAN |
LANNETT CO INC |
Manufacturing (CMC) |
Approval |
06/26/2018 |
SUMATRIPTAN ANDA #204841 |
SUPPL-11 |
SUMATRIPTAN |
LANNETT CO INC |
Labeling |
Approval |
06/26/2018 |
VIBERZI NDA #206940 |
SUPPL-6 |
ELUXADOLINE |
ABBVIE |
Labeling |
Approval |
06/26/2018 |
DEXTROSE 5% IN PLASTIC CONTAINER ANDA #207449 |
SUPPL-3 |
DEXTROSE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/26/2018 |
NICOTINE POLACRILEX ANDA #209206 |
ORIG-1 |
NICOTINE POLACRILEX |
P AND L |
|
Approval |
06/26/2018 |
SODIUM NITROPRUSSIDE ANDA #209834 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
CHARTWELL RX |
|
Approval |
06/26/2018 |
FENOFIBRATE (MICRONIZED) ANDA #210782 |
ORIG-1 |
FENOFIBRATE |
TORRENT |
|
Approval |
06/26/2018 |
TECENTRIQ BLA #761034 |
SUPPL-11 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
06/27/2018 |
HABITROL NDA #020076 |
SUPPL-49 |
NICOTINE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/27/2018 |
LAMICTAL NDA #020241 |
SUPPL-57 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
06/27/2018 |
LAMICTAL CD NDA #020764 |
SUPPL-50 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
06/27/2018 |
EVISTA NDA #020815 |
SUPPL-34 |
RALOXIFENE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
06/27/2018 |
LAMICTAL XR NDA #022115 |
SUPPL-23 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
06/27/2018 |
LAMICTAL ODT NDA #022251 |
SUPPL-21 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
06/27/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090385 |
SUPPL-5 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/27/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090385 |
SUPPL-6 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/27/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090385 |
SUPPL-7 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/27/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090385 |
SUPPL-8 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/27/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090385 |
SUPPL-9 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/27/2018 |
METHYLPREDNISOLONE ACETATE ANDA #201835 |
ORIG-1 |
METHYLPREDNISOLONE ACETATE |
SAGENT PHARMS INC |
|
Approval |
06/27/2018 |
SILDENAFIL CITRATE ANDA #202023 |
ORIG-1 |
SILDENAFIL CITRATE |
AMNEAL PHARMS NY |
|
Approval |
06/27/2018 |
XARELTO NDA #202439 |
SUPPL-27 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
06/27/2018 |
CELECOXIB ANDA #204776 |
SUPPL-1 |
CELECOXIB |
MICRO LABS |
Manufacturing (CMC) |
Approval |
06/27/2018 |
BRAFTOVI NDA #210496 |
ORIG-1 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Type 1 - New Molecular Entity |
Approval |
06/27/2018 |
MEKTOVI NDA #210498 |
ORIG-1 |
BINIMETINIB |
ARRAY BIOPHARMA INC |
Type 1 - New Molecular Entity |
Approval |
06/28/2018 |
HYCODAN NDA #005213 |
SUPPL-39 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
GENUS |
Labeling |
Approval |
06/28/2018 |
PHENERGAN VC W/ CODEINE NDA #008306 |
SUPPL-34 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
06/28/2018 |
PHENERGAN W/ CODEINE NDA #008306 |
SUPPL-34 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
06/28/2018 |
TUSSIONEX PENNKINETIC NDA #019111 |
SUPPL-22 |
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX |
UCB INC |
Labeling |
Approval |
06/28/2018 |
CELEBREX NDA #020998 |
SUPPL-50 |
CELECOXIB |
UPJOHN |
Efficacy |
Approval |
06/28/2018 |
HYCOFENIX NDA #022279 |
SUPPL-2 |
GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
06/28/2018 |
FLOWTUSS NDA #022424 |
SUPPL-2 |
GUAIFENESIN; HYDROCODONE BITARTRATE |
CHARTWELL RX |
Labeling |
Approval |
06/28/2018 |
ZUTRIPRO NDA #022439 |
SUPPL-10 |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
PERSION |
Labeling |
Approval |
06/28/2018 |
REZIRA NDA #022442 |
SUPPL-10 |
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
PERSION |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #040151 |
SUPPL-20 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/28/2018 |
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE ANDA #040295 |
SUPPL-9 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #040613 |
SUPPL-10 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE WITH CODEINE ANDA #040650 |
SUPPL-25 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/28/2018 |
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #040660 |
SUPPL-25 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/28/2018 |
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #040660 |
SUPPL-26 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #040674 |
SUPPL-7 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #088008 |
SUPPL-18 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
WOCKHARDT BIO AG |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #088017 |
SUPPL-49 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
06/28/2018 |
TUSSIGON ANDA #088508 |
SUPPL-19 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
KING PHARMS |
Labeling |
Approval |
06/28/2018 |
TUSSIGON ANDA #088508 |
SUPPL-20 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
KING PHARMS |
Labeling |
Approval |
06/28/2018 |
TUSSIGON ANDA #088508 |
SUPPL-21 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
KING PHARMS |
Labeling |
Approval |
06/28/2018 |
TRIACIN-C ANDA #088704 |
SUPPL-38 |
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
ANIMA |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #088763 |
SUPPL-89 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
06/28/2018 |
PROMETH VC W/ CODEINE ANDA #088764 |
SUPPL-88 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #088875 |
SUPPL-39 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
WOCKHARDT BIO AG |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #089647 |
SUPPL-16 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #090180 |
SUPPL-8 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE ANDA #090180 |
SUPPL-8 |
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE |
NOSTRUM LABS INC |
Labeling |
Approval |
06/28/2018 |
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE ANDA #091528 |
SUPPL-4 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
NOVEL LABS INC |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #200386 |
SUPPL-8 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
TRIS PHARMA INC |
Labeling |
Approval |
06/28/2018 |
CASPOFUNGIN ACETATE ANDA #200833 |
ORIG-1 |
CASPOFUNGIN ACETATE |
HENGRUI PHARMA |
|
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #200894 |
SUPPL-5 |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/28/2018 |
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE ANDA #200963 |
SUPPL-5 |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/28/2018 |
ELIQUIS NDA #202155 |
SUPPL-20 |
APIXABAN |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #203535 |
SUPPL-2 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
NOVEL LABS INC |
Labeling |
Approval |
06/28/2018 |
VITUZ NDA #204307 |
SUPPL-4 |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
PERSION |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #204765 |
SUPPL-2 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
APOZEAL PHARMS |
Labeling |
Approval |
06/28/2018 |
OBREDON NDA #205474 |
SUPPL-5 |
GUAIFENESIN; HYDROCODONE BITARTRATE |
SOVEREIGN PHARMS |
Labeling |
Approval |
06/28/2018 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #205731 |
SUPPL-2 |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
PADAGIS US |
Labeling |
Approval |
06/28/2018 |
CASPOFUNGIN ACETATE NDA #206110 |
SUPPL-1 |
CASPOFUNGIN ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/28/2018 |
TUXARIN ER NDA #206323 |
SUPPL-6 |
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE |
MAINPOINTE |
Labeling |
Approval |
06/28/2018 |
NUPLAZID NDA #207318 |
SUPPL-3 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Efficacy |
Approval |
06/28/2018 |
TUZISTRA XR NDA #207768 |
SUPPL-7 |
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX |
TRIS PHARMA INC |
Labeling |
Approval |
06/28/2018 |
NERLYNX NDA #208051 |
SUPPL-2 |
NERATINIB MALEATE |
PUMA BIOTECH |
Labeling |
Approval |
06/28/2018 |
ZEPATIER NDA #208261 |
SUPPL-5 |
ELBASVIR; GRAZOPREVIR |
MSD SUB MERCK |
Labeling |
Approval |
06/28/2018 |
QBREXZA NDA #210361 |
ORIG-1 |
GLYCOPYRRONIUM TOSYLATE |
JOURNEY |
Type 3 - New Dosage Form |
Approval |
06/28/2018 |
NUPLAZID NDA #210793 |
ORIG-1 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Type 3 - New Dosage Form |
Approval |
06/29/2018 |
TRULICITY BLA #125469 |
SUPPL-17 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
06/29/2018 |
SUPRAX NDA #203195 |
SUPPL-9 |
CEFIXIME |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
06/29/2018 |
SIGNIFOR LAR KIT NDA #203255 |
SUPPL-4 |
PASIREOTIDE PAMOATE |
RECORDATI RARE |
Efficacy |
Approval |
06/29/2018 |
RISEDRONATE SODIUM ANDA #205066 |
ORIG-1 |
RISEDRONATE SODIUM |
IMPAX LABS INC |
|
Approval |
06/29/2018 |
OMEPRAZOLE ANDA #205070 |
ORIG-1 |
OMEPRAZOLE |
MYLAN |
|
Approval |
06/29/2018 |
ZOLEDRONIC ANDA #205749 |
ORIG-1 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
|
Approval |
06/29/2018 |
ZOLEDRONIC ACID ANDA #205749 |
ORIG-1 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
|
Approval |
06/29/2018 |
LIDOCAINE AND PRILOCAINE ANDA #205887 |
ORIG-1 |
LIDOCAINE; PRILOCAINE |
PAI HOLDINGS PHARM |
|
Approval |
06/29/2018 |
ICLEVIA ANDA #206850 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AUROBINDO PHARMA LTD |
|
Approval |
06/29/2018 |
IBUPROFEN ANDA #206989 |
ORIG-1 |
IBUPROFEN |
STRIDES PHARMA |
|
Approval |
06/29/2018 |
ALBUTEROL SULFATE ANDA #207046 |
ORIG-1 |
ALBUTEROL SULFATE |
RISING |
|
Approval |
06/29/2018 |
IBUPROFEN ANDA #207753 |
ORIG-1 |
IBUPROFEN |
AUROBINDO PHARMA LTD |
|
Approval |
06/29/2018 |
YONDELIS NDA #207953 |
SUPPL-4 |
TRABECTEDIN |
JANSSEN PRODS |
Efficacy |
Approval |
06/29/2018 |
OLMESARTAN MEDOXOMIL ANDA #208130 |
ORIG-1 |
OLMESARTAN MEDOXOMIL |
SCIEGEN PHARMS INC |
|
Approval |
06/29/2018 |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE ANDA #208360 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; TRIAMTERENE |
ZYDUS PHARMS |
|
Approval |
06/29/2018 |
LORATADINE ANDA #208931 |
ORIG-1 |
LORATADINE |
AUROBINDO PHARMA LTD |
|
Approval |
06/29/2018 |
ARISTADA INITIO KIT NDA #209830 |
ORIG-1 |
ARIPIPRAZOLE LAUROXIL |
ALKERMES INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/29/2018 |
NIFEDIPINE ANDA #210184 |
ORIG-1 |
NIFEDIPINE |
ZYDUS PHARMS |
|
Approval |