Drugs@FDA: FDA Approved Drug Products

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All Approvals
June 2018

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on June 22, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2018 NOVOLIN R
NDA #019938
SUPPL-76 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Labeling Approval
06/01/2018 NOVOLIN N
NDA #019959
SUPPL-74 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Labeling Approval
06/01/2018 NOVOLIN N
NDA #019959
SUPPL-79 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Labeling Approval
06/01/2018 NOVOLIN 70/30
NDA #019991
SUPPL-75 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Labeling Approval
06/01/2018 NOVOLIN 70/30
NDA #019991
SUPPL-79 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Labeling 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 DAIICHI SANKYO INC Labeling Approval
06/01/2018 NADOLOL
ANDA #210786
ORIG-1 NADOLOL RICONPHARMA LLC 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 AEGERION REMS Approval
06/04/2018 PREZCOBIX
NDA #205395
SUPPL-9 COBICISTAT; DARUNAVIR ETHANOLATE JANSSEN PRODS Efficacy Approval
06/04/2018 NICOTINE POLACRILEX
ANDA #208875
ORIG-1 NICOTINE POLACRILEX WATSON LABS INC Tentative Approval
06/04/2018 TAFLUPROST
ANDA #209040
ORIG-1 TAFLUPROST SANDOZ INC Tentative Approval
06/04/2018 SUCCINYLCHOLINE CHLORIDE
ANDA #210231
ORIG-1 SUCCINYLCHOLINE CHLORIDE RENAISSANCE SSA LLC Approval
06/04/2018 FLUOCINONIDE
ANDA #211111
ORIG-1 FLUOCINONIDE AMNEAL PHARMS LLC Approval
06/04/2018 FULPHILA
BLA #761075
ORIG-1 PEGFILGRASTIM-JMDB MYLAN GMBH Approval
06/05/2018 NICORETTE
NDA #018612
SUPPL-80 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
06/05/2018 NICORETTE (MINT)
NDA #018612
SUPPL-80 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
06/05/2018 NICORETTE
NDA #020066
SUPPL-61 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
06/05/2018 NICORETTE (MINT)
NDA #020066
SUPPL-61 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
06/05/2018 NICORETTE
NDA #022360
SUPPL-11 NICOTINE POLACRILEX GLAXOSMITHKLINE CONS 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 FULVESTRANT
ANDA #205935
ORIG-1 FULVESTRANT SANDOZ INC Tentative 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 ALLERGAN Labeling Approval
06/06/2018 PRED MILD
NDA #017100
SUPPL-45 PREDNISOLONE ACETATE ALLERGAN Labeling Approval
06/06/2018 COLISTIMETHATE SODIUM
ANDA #064216
SUPPL-15 COLISTIMETHATE SODIUM X GEN 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 LTD 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 EISAI INC Labeling Approval
06/07/2018 PROTONIX
NDA #020987
SUPPL-54 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
06/07/2018 PROTONIX IV
NDA #020988
SUPPL-60 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
06/07/2018 NEXIUM
NDA #021153
SUPPL-53 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA PHARMS 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 SANTARUS INC Labeling Approval
06/07/2018 ZEGERID
NDA #021849
SUPPL-14 OMEPRAZOLE; SODIUM BICARBONATE SANTARUS INC Labeling Approval
06/07/2018 NEXIUM
NDA #021957
SUPPL-20 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA PHARMS Labeling Approval
06/07/2018 PROTONIX
NDA #022020
SUPPL-16 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
06/07/2018 PRILOSEC
NDA #022056
SUPPL-22 OMEPRAZOLE MAGNESIUM COVIS PHARMA BV Labeling Approval
06/07/2018 NEXIUM
NDA #022101
SUPPL-17 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA PHARMS 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 PHARMA USA 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
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 MYLAN 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 GENERICS 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 R2 PHARMA LLC 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 THERAP Efficacy Approval
06/07/2018 OMEPRAZOLE
ANDA #203270
SUPPL-8 OMEPRAZOLE AUROBINDO PHARMA LTD Labeling Approval
06/07/2018 OMEPRAZOLE
ANDA #203481
SUPPL-1 OMEPRAZOLE BRECKENRIDGE PHARM 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 CERECOR INC Labeling Approval
06/07/2018 YOSPRALA
NDA #205103
SUPPL-4 ASPIRIN; OMEPRAZOLE ARALEZ PHARMS Labeling Approval
06/07/2018 ETODOLAC
ANDA #208834
ORIG-1 ETODOLAC AMNEAL PHARMS CO Approval
06/08/2018 SPECTAZOLE
NDA #018751
SUPPL-25 ECONAZOLE NITRATE ALVOGEN MALTA Labeling 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 WEST-WARD PHARMS INT Labeling Approval
06/08/2018 HALOPERIDOL
ANDA #075858
SUPPL-21 HALOPERIDOL LACTATE WEST-WARD PHARMS INT 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 ACTAVIS MID ATLANTIC 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 BUPROPION HYDROCHLORIDE
ANDA #203013
ORIG-1 BUPROPION HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
06/08/2018 GATIFLOXACIN
ANDA #206446
ORIG-1 GATIFLOXACIN MICRO LABS 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 Approval
06/08/2018 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #207521
ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE SOMERSET THERAPS LLC Approval
06/08/2018 VENCLEXTA
NDA #208573
SUPPL-4 VENETOCLAX ABBVIE INC Efficacy Approval
06/08/2018 VENCLEXTA
NDA #208573
SUPPL-5 VENETOCLAX ABBVIE INC 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 INC REMS Approval
06/11/2018 SUBOXONE
NDA #020733
SUPPL-23 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC REMS Approval
06/11/2018 SUBOXONE
NDA #022410
SUPPL-33 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC REMS Approval
06/11/2018 AZITHROMYCIN
ANDA #065360
SUPPL-8 AZITHROMYCIN MYLAN Labeling Approval
06/11/2018 CEFTRIAXONE
ANDA #091049
ORIG-1 CEFTRIAXONE SODIUM SAGENT PHARMS Approval
06/11/2018 SILDENAFIL CITRATE
ANDA #091448
ORIG-1 SILDENAFIL CITRATE TORRENT PHARMS LTD 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 RES PVT LTD Approval
06/11/2018 ROPIVACAINE HYDROCHLORIDE
ANDA #206166
ORIG-1 ROPIVACAINE HYDROCHLORIDE INFORLIFE Approval
06/11/2018 LACTULOSE
ANDA #207786
ORIG-1 LACTULOSE BIO-PHARM INC 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 PHARMS 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 PHARMA Labeling Approval
06/12/2018 ISOPROTERENOL HYDROCHLORIDE
ANDA #210322
ORIG-1 ISOPROTERENOL HYDROCHLORIDE CIPLA LTD Approval
06/12/2018 DIFLORASONE DIACETATE
ANDA #210753
ORIG-1 DIFLORASONE DIACETATE TELIGENT PHARMA INC 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 OREXIGEN 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 PHARMS LTD Approval
06/13/2018 MOXIDECTIN
NDA #210867
ORIG-1 MOXIDECTIN MEDICINES DEVELOPMENT FOR GLOBAL HEALTH 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
SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling 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 MERCK SHARP DOHME Labeling Approval
06/15/2018 ISENTRESS HD
NDA #022145
SUPPL-39 RALTEGRAVIR POTASSIUM MERCK SHARP DOHME 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 LTD 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 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 CHEMO RESEARCH SL Approval
06/15/2018 NEOSTIGMINE METHYLSULFATE
ANDA #210051
ORIG-1 NEOSTIGMINE METHYLSULFATE AMNEAL PHARMS CO 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 EAGLE PHARMS 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 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 INDICUS PHARMA Approval
06/18/2018 FLUCYTOSINE
ANDA #207536
ORIG-1 FLUCYTOSINE RECIPHARM 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 #211035
ORIG-1 VERAPAMIL HYDROCHLORIDE SOMERSET THERAPS LLC 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 HI TECH PHARMA Labeling Approval
06/19/2018 PROMETHAZINE WITH CODEINE
ANDA #040650
SUPPL-22 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE VINTAGE Labeling Approval
06/19/2018 M-ZOLE 3 COMBINATION PACK
ANDA #074926
SUPPL-18 MICONAZOLE NITRATE ACTAVIS MID ATLANTIC 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 TELIGENT PHARMA INC Approval
06/19/2018 TESTOSTERONE CYPIONATE
ANDA #210362
ORIG-1 TESTOSTERONE CYPIONATE CIPLA LTD Approval
06/19/2018 TECENTRIQ
BLA #761034
SUPPL-10 ATEZOLIZUMAB GENENTECH INC Approval
06/20/2018 EXTINA
NDA #021738
SUPPL-7 KETOCONAZOLE MYLAN PHARMS INC 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 HEALTH INC Labeling Approval
06/21/2018 PEPCID
NDA #019462
SUPPL-39 FAMOTIDINE VALEANT PHARMS NORTH 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 RYDAPT
NDA #207997
SUPPL-2 MIDOSTAURIN NOVARTIS PHARMS CORP Labeling Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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