Drugs@FDA: FDA Approved Drug Products

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All Approvals
April 2019

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 April 20, 2019.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2019 DOCETAXEL
ANDA #204193
SUPPL-6 DOCETAXEL DR REDDYS LABS LTD Labeling Approval
04/01/2019 DOCETAXEL
ANDA #208137
ORIG-1 DOCETAXEL MYLAN LABS LTD Approval
04/01/2019 MIRABEGRON
ANDA #209488
ORIG-1 MIRABEGRON ZYDUS PHARMS USA INC Tentative Approval
04/01/2019 PANTOPRAZOLE SODIUM
ANDA #209524
ORIG-1 PANTOPRAZOLE SODIUM HANGZHOU ZHONGMEI HUADONG Tentative Approval
04/01/2019 LEVOCETIRIZINE HYDROCHLORIDE
ANDA #210914
ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Approval
04/02/2019 VYTORIN
NDA #021687
SUPPL-52 EZETIMIBE; SIMVASTATIN MSD INTL Labeling Approval
04/02/2019 XYZAL
NDA #022064
SUPPL-38 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
04/02/2019 XYZAL
NDA #022157
SUPPL-20 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
04/02/2019 ADDYI
NDA #022526
SUPPL-7 FLIBANSERIN SPROUT PHARMS REMS Approval
04/02/2019 BENAZEPRIL HYDROCHLORIDE
ANDA #076430
SUPPL-12 BENAZEPRIL HYDROCHLORIDE MYLAN Labeling Approval
04/02/2019 BENAZEPRIL HYDROCHLORIDE
ANDA #077128
SUPPL-15 BENAZEPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
04/02/2019 BENAZEPRIL HYDROCHLORIDE
ANDA #078212
SUPPL-17 BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/02/2019 EPLERENONE
ANDA #078510
SUPPL-13 EPLERENONE SANDOZ Labeling Approval
04/02/2019 EPLERENONE
ANDA #078510
SUPPL-14 EPLERENONE SANDOZ Labeling Approval
04/02/2019 CELECOXIB
ANDA #078857
SUPPL-5 CELECOXIB MYLAN PHARMS INC Labeling Approval
04/02/2019 AZELASTINE HYDROCHLORIDE
ANDA #090423
SUPPL-19 AZELASTINE HYDROCHLORIDE SUN PHARM Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #091479
SUPPL-10 SILDENAFIL CITRATE TORRENT PHARMS LTD Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #091479
SUPPL-11 SILDENAFIL CITRATE TORRENT PHARMS LTD Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #201150
SUPPL-3 SILDENAFIL CITRATE MYLAN PHARMS INC Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #201150
SUPPL-6 SILDENAFIL CITRATE MYLAN PHARMS INC Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #201150
SUPPL-7 SILDENAFIL CITRATE MYLAN PHARMS INC Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #201150
SUPPL-9 SILDENAFIL CITRATE MYLAN PHARMS INC Labeling Approval
04/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #201653
SUPPL-4 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #201653
SUPPL-5 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #201653
SUPPL-6 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/02/2019 EZETIMIBE AND SIMVASTATIN
ANDA #201890
SUPPL-5 EZETIMIBE; SIMVASTATIN ANI PHARMS INC Labeling Approval
04/02/2019 CARISOPRODOL
ANDA #203374
SUPPL-12 CARISOPRODOL SCIEGEN PHARMS INC Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #203623
SUPPL-1 SILDENAFIL CITRATE HETERO LABS LTD V Labeling Approval
04/02/2019 SILDENAFIL CITRATE
ANDA #203623
SUPPL-3 SILDENAFIL CITRATE HETERO LABS LTD V Labeling Approval
04/02/2019 LINEZOLID
ANDA #204239
SUPPL-1 LINEZOLID HETERO LABS LTD V Labeling Approval
04/02/2019 LINEZOLID
ANDA #204239
SUPPL-2 LINEZOLID HETERO LABS LTD V Labeling Approval
04/02/2019 TELMISARTAN
ANDA #206511
SUPPL-3 TELMISARTAN AUROBINDO PHARMA LTD Labeling Approval
04/02/2019 SELEGILINE HYDROCHLORIDE
ANDA #206803
ORIG-1 SELEGILINE HYDROCHLORIDE PACK PHARMS LLC Approval
04/02/2019 FINGOLIMOD
ANDA #207939
ORIG-1 FINGOLIMOD HEC PHARM Tentative Approval
04/02/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #208572
SUPPL-1 ASPIRIN; DIPYRIDAMOLE SUN PHARM Labeling Approval
04/02/2019 CELECOXIB
ANDA #208833
SUPPL-1 CELECOXIB AMNEAL PHARMS Labeling Approval
04/02/2019 BUPIVACAINE HYDROCHLORIDE
ANDA #209087
ORIG-1 BUPIVACAINE HYDROCHLORIDE B BRAUN MEDICAL INC Approval
04/02/2019 CARMUSTINE
ANDA #209278
ORIG-1 CARMUSTINE STI PHARMA LLC Approval
04/02/2019 BETAMETHASONE DIPROPIONATE
ANDA #211540
ORIG-1 BETAMETHASONE DIPROPIONATE PERRIGO UK FINCO Tentative Approval
04/03/2019 LOTRONEX
NDA #021107
SUPPL-29 ALOSETRON HYDROCHLORIDE SEBELA IRELAND LTD Labeling Approval
04/03/2019 LOVAZA
NDA #021654
SUPPL-43 OMEGA-3-ACID ETHYL ESTERS SMITHKLINE BEECHAM Labeling Approval
04/03/2019 BRILINTA
NDA #022433
SUPPL-23 TICAGRELOR ASTRAZENECA PHARMS Efficacy Approval
04/03/2019 CLOPIDOGREL BISULFATE
ANDA #090540
SUPPL-12 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
04/03/2019 CLOPIDOGREL BISULFATE
ANDA #090540
SUPPL-13 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
04/03/2019 CLOPIDOGREL BISULFATE
ANDA #090540
SUPPL-14 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
04/03/2019 CLOPIDOGREL BISULFATE
ANDA #090540
SUPPL-15 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
04/03/2019 CLOPIDOGREL BISULFATE
ANDA #090540
SUPPL-17 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
04/03/2019 AMPICILLIN SODIUM
ANDA #090889
SUPPL-1 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
04/03/2019 AMPICILLIN SODIUM
ANDA #090889
SUPPL-2 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
04/03/2019 AVASTIN
BLA #125085
SUPPL-329 BEVACIZUMAB GENENTECH Approval
04/03/2019 EPLERENONE
ANDA #206922
SUPPL-1 EPLERENONE ACCORD HLTHCARE Labeling Approval
04/03/2019 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-2 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
04/03/2019 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-8 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
04/03/2019 ESTRADIOL AND NORETHINDRONE ACETATE
ANDA #210612
ORIG-1 ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
04/03/2019 WELCHOL
NDA #210895
ORIG-1 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO INC Type 3 - New Dosage Form Approval
04/03/2019 PERMETHRIN
ANDA #211303
ORIG-1 PERMETHRIN ENCUBE ETHICALS Approval
04/03/2019 FLUOCINONIDE
ANDA #211758
ORIG-1 FLUOCINONIDE TELIGENT PHARMA INC Approval
04/04/2019 SOMA
NDA #011792
SUPPL-50 CARISOPRODOL MYLAN SPECIALITY LP Labeling Approval
04/04/2019 ZANTAC 75
NDA #020520
SUPPL-37 RANITIDINE HYDROCHLORIDE SANOFI US Labeling Approval
04/04/2019 PRILOSEC OTC
NDA #021229
SUPPL-33 OMEPRAZOLE MAGNESIUM ASTRAZENECA PHARMS Labeling Approval
04/04/2019 ZANTAC 150
NDA #021698
SUPPL-29 RANITIDINE HYDROCHLORIDE SANOFI US Labeling Approval
04/04/2019 MOMETASONE FUROATE
ANDA #075919
SUPPL-6 MOMETASONE FUROATE FOUGERA PHARMS Labeling Approval
04/04/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629
SUPPL-19 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Manufacturing (CMC) Approval
04/04/2019 BICALUTAMIDE
ANDA #200274
SUPPL-1 BICALUTAMIDE APOTEX INC Labeling Approval
04/04/2019 BICALUTAMIDE
ANDA #200274
SUPPL-2 BICALUTAMIDE APOTEX INC Labeling Approval
04/04/2019 BUSULFAN
ANDA #202259
SUPPL-2 BUSULFAN LUITPOLD Labeling Approval
04/04/2019 BUSULFAN
ANDA #202259
SUPPL-4 BUSULFAN LUITPOLD Labeling Approval
04/04/2019 BUSULFAN
ANDA #202259
SUPPL-6 BUSULFAN LUITPOLD Labeling Approval
04/04/2019 TELMISARTAN AND AMLODIPINE
ANDA #202517
SUPPL-4 AMLODIPINE BESYLATE; TELMISARTAN TORRENT Labeling Approval
04/04/2019 TELMISARTAN AND AMLODIPINE
ANDA #202517
SUPPL-7 AMLODIPINE BESYLATE; TELMISARTAN TORRENT Labeling Approval
04/04/2019 LOSARTAN POTASSIUM
ANDA #203835
SUPPL-4 LOSARTAN POTASSIUM HETERO LABS LTD V Labeling Approval
04/04/2019 RIVASTIGMINE TARTRATE
ANDA #204572
SUPPL-2 RIVASTIGMINE TARTRATE AUROBINDO PHARMA LTD Labeling Approval
04/04/2019 RIVASTIGMINE TARTRATE
ANDA #204572
SUPPL-5 RIVASTIGMINE TARTRATE AUROBINDO PHARMA LTD Labeling Approval
04/04/2019 NEXIUM 24HR
NDA #204655
SUPPL-11 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
04/04/2019 LOSARTAN POTASSIUM
ANDA #204795
ORIG-1 LOSARTAN POTASSIUM HISUN PHARM HANGZHOU Approval
04/04/2019 BUSULFAN
ANDA #205106
SUPPL-1 BUSULFAN ATHENEX INC Labeling Approval
04/04/2019 BUSULFAN
ANDA #205139
SUPPL-2 BUSULFAN ACTAVIS LLC Labeling Approval
04/04/2019 BUSULFAN
ANDA #205139
SUPPL-3 BUSULFAN ACTAVIS LLC Labeling Approval
04/04/2019 TIGECYCLINE
NDA #205645
SUPPL-3 TIGECYCLINE FRESENIUS KABI USA Labeling Approval
04/04/2019 PITAVASTATIN CALCIUM
ANDA #206070
ORIG-1 PITAVASTATIN CALCIUM MYLAN PHARMS INC Approval
04/04/2019 ENTECAVIR
ANDA #206745
SUPPL-1 ENTECAVIR ZYDUS PHARMS Labeling Approval
04/04/2019 ENTECAVIR
ANDA #206745
SUPPL-3 ENTECAVIR ZYDUS PHARMS Labeling Approval
04/04/2019 ENTECAVIR
ANDA #206745
SUPPL-4 ENTECAVIR ZYDUS PHARMS Labeling Approval
04/04/2019 IBRANCE
NDA #207103
SUPPL-8 PALBOCICLIB PFIZER INC Efficacy Approval
04/04/2019 NEXIUM 24HR
NDA #207920
SUPPL-5 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
04/04/2019 HALOPERIDOL DECANOATE
ANDA #209101
SUPPL-1 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
04/04/2019 HALOPERIDOL DECANOATE
ANDA #209101
SUPPL-2 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
04/04/2019 PLENVU
NDA #209381
SUPPL-1 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE SALIX Labeling Approval
04/04/2019 OLOPATADINE HYDROCHLORIDE
ANDA #209995
ORIG-1 OLOPATADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
04/04/2019 TREMFYA
BLA #761061
SUPPL-2 GUSELKUMAB JANSSEN BIOTECH Approval
04/05/2019 RAPAMUNE
NDA #021083
SUPPL-65 SIROLIMUS PF PRISM CV Labeling Approval
04/05/2019 RAPAMUNE
NDA #021110
SUPPL-84 SIROLIMUS PF PRISM CV Labeling Approval
04/05/2019 SERTRALINE HYDROCHLORIDE
ANDA #076934
SUPPL-7 SERTRALINE HYDROCHLORIDE ACI HEALTHCARE LTD Labeling Approval
04/05/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #078807
SUPPL-10 METOCLOPRAMIDE HYDROCHLORIDE IPCA LABS LTD Labeling Approval
04/05/2019 ARIPIPRAZOLE
ANDA #201519
SUPPL-33 ARIPIPRAZOLE TORRENT Labeling Approval
04/05/2019 ARIPIPRAZOLE
ANDA #201519
SUPPL-35 ARIPIPRAZOLE TORRENT Labeling Approval
04/05/2019 ARIPIPRAZOLE
ANDA #201519
SUPPL-36 ARIPIPRAZOLE TORRENT Labeling Approval
04/05/2019 DIFICID
NDA #201699
SUPPL-11 FIDAXOMICIN CUBIST PHARMS LLC Labeling Approval
04/05/2019 KETOROLAC TROMETHAMINE
ANDA #203410
ORIG-1 KETOROLAC TROMETHAMINE MICRO LABS LTD INDIA Approval
04/05/2019 LACOSAMIDE
ANDA #204947
ORIG-1 LACOSAMIDE ZYDUS PHARMS USA INC Tentative Approval
04/05/2019 TOFACITINIB CITRATE
ANDA #209829
ORIG-1 TOFACITINIB CITRATE ZYDUS PHARMS USA INC Tentative Approval
04/05/2019 Bortezomib
ANDA #210615
ORIG-1 BORTEZOMIB SHILPA MEDICARE LTD Tentative Approval
04/05/2019 THIOTHIXENE
ANDA #211642
ORIG-1 THIOTHIXENE NOVITIUM PHARMA Approval
04/05/2019 RANITIDINE HYDROCHLORIDE
ANDA #211893
ORIG-1 RANITIDINE HYDROCHLORIDE APPCO PHARMA LLC Approval
04/08/2019 ULTRAM
NDA #020281
SUPPL-41 TRAMADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
04/08/2019 SOLTAMOX
NDA #021807
SUPPL-6 TAMOXIFEN CITRATE MIDATECH PHARMA US Labeling Approval
04/08/2019 OMEPRAZOLE
NDA #022032
SUPPL-41 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-5 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-6 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-7 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-8 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-9 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 IMATINIB MESYLATE
ANDA #078340
SUPPL-12 IMATINIB MESYLATE SUN PHARM Labeling Approval
04/08/2019 MENEST
ANDA #084948
SUPPL-23 ESTROGENS, ESTERIFIED MONARCH PHARMS Labeling Approval
04/08/2019 MENEST
ANDA #084949
SUPPL-23 ESTROGENS, ESTERIFIED MONARCH PHARMS Labeling Approval
04/08/2019 MENEST
ANDA #084950
SUPPL-20 ESTROGENS, ESTERIFIED MONARCH PHARMS Labeling Approval
04/08/2019 MENEST
ANDA #084951
SUPPL-24 ESTROGENS, ESTERIFIED MONARCH PHARMS Labeling Approval
04/08/2019 TETRABENAZINE
ANDA #209739
ORIG-1 TETRABENAZINE WEST-WARD PHARMS INT Approval
04/08/2019 ICATIBANT
ANDA #210118
ORIG-1 ICATIBANT TEVA PHARMS USA INC Tentative Approval
04/08/2019 CLOMIPRAMINE HYDROCHLORIDE
ANDA #211767
ORIG-1 CLOMIPRAMINE HYDROCHLORIDE MANKIND PHARMA Approval
04/08/2019 DOLUTEGRAVIR; LAMIVUDINE
NDA #211994
ORIG-1 DOLUTEGRAVIR;LAMIVUDINE VIIV HLTHCARE Type 4 - New Combination Approval
04/09/2019 PAMELOR
NDA #018013
SUPPL-64 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Labeling Approval
04/09/2019 PEPCID AC
NDA #020325
SUPPL-33 FAMOTIDINE J AND J CONSUMER INC Labeling Approval
04/09/2019 AXID AR
NDA #020555
SUPPL-10 NIZATIDINE PFIZER Labeling Approval
04/09/2019 VAGIFEM
NDA #020908
SUPPL-26 ESTRADIOL NOVO NORDISK INC Labeling Approval
04/09/2019 PEPCID COMPLETE
NDA #020958
SUPPL-28 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE J AND J CONSUMER INC Labeling Approval
04/09/2019 PREVACID 24 HR
NDA #022327
SUPPL-27 LANSOPRAZOLE GLAXOSMITHKLINE CONS Labeling Approval
04/09/2019 ROSUVASTATIN CALCIUM
ANDA #207626
ORIG-1 ROSUVASTATIN CALCIUM UMEDICA LABS PVT LTD Approval
04/09/2019 LANSOPRAZOLE
NDA #208025
SUPPL-8 LANSOPRAZOLE DEXCEL PHARMA Labeling Approval
04/09/2019 HYDROXYPROGESTERONE CAPROATE
ANDA #208381
ORIG-1 HYDROXYPROGESTERONE CAPROATE SUN PHARM Approval
04/09/2019 DECITABINE
ANDA #209056
ORIG-1 DECITABINE WOCKHARDT BIO AG Approval
04/09/2019 SEYSARA
NDA #209521
SUPPL-1 SARECYCLINE HYDROCHLORIDE ALMIRALL Labeling Approval
04/09/2019 OZEMPIC
NDA #209637
SUPPL-1 SEMAGLUTIDE NOVO Labeling Approval
04/09/2019 EVENITY
BLA #761062
ORIG-1 ROMOSOZUMAB-AQQG AMGEN INC Approval
04/10/2019 WELCHOL
NDA #022362
SUPPL-24 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO Labeling Approval
04/10/2019 TESTOSTERONE
ANDA #204570
ORIG-1 TESTOSTERONE ACTAVIS LABS UT INC Approval
04/10/2019 ALEVE PM
NDA #205352
SUPPL-13 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
04/10/2019 TESTOSTERONE
ANDA #207373
ORIG-1 TESTOSTERONE AMNEAL PHARMS LLC Approval
04/10/2019 LURASIDONE HYDROCHLORIDE
ANDA #208058
ORIG-1 LURASIDONE HYDROCHLORIDE EMCURE PHARMS LTD Tentative Approval
04/10/2019 NAFTIFINE HYDROCHLORIDE
ANDA #208201
ORIG-1 NAFTIFINE HYDROCHLORIDE TARO Approval
04/10/2019 AMBRISENTAN
ANDA #208354
ORIG-1 AMBRISENTAN SIGMAPHARM LABS LLC Approval
04/10/2019 TESTOSTERONE
ANDA #208560
ORIG-1 TESTOSTERONE LUPIN ATLANTIS Approval
04/10/2019 TESTOSTERONE
ANDA #208620
ORIG-1 TESTOSTERONE DR REDDYS LABS INC Approval
04/10/2019 AMBRISENTAN
ANDA #209509
ORIG-1 AMBRISENTAN PAR PHARM INC Approval
04/10/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #209647
ORIG-1 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Approval
04/10/2019 SODIUM NITROPRUSSIDE
ANDA #210114
ORIG-1 SODIUM NITROPRUSSIDE DR REDDYS LABS LTD Approval
04/10/2019 TEMIXYS
NDA #211284
SUPPL-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE CELLTRION Labeling Approval
04/11/2019 DESOXYN
NDA #005378
SUPPL-35 METHAMPHETAMINE HYDROCHLORIDE RECORDATI RARE Labeling Approval
04/11/2019 SANDOSTATIN
NDA #019667
SUPPL-67 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
04/11/2019 NAPHCON-A
NDA #020226
SUPPL-29 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE ALCON Labeling Approval
04/11/2019 MIFEPREX
NDA #020687
SUPPL-22 MIFEPRISTONE DANCO LABS LLC REMS Approval
04/11/2019 SANDOSTATIN LAR
NDA #021008
SUPPL-43 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
04/11/2019 SOMATULINE DEPOT
NDA #022074
SUPPL-24 LANREOTIDE ACETATE IPSEN PHARMA Labeling Approval
04/11/2019 ZYPREXA RELPREVV
NDA #022173
SUPPL-32 OLANZAPINE PAMOATE ELI LILLY CO REMS Approval
04/11/2019 ADDYI
NDA #022526
SUPPL-6 FLIBANSERIN SPROUT PHARMS Supplement Approval
04/11/2019 CLOPIDOGREL BISULFATE
ANDA #077665
SUPPL-7 CLOPIDOGREL BISULFATE MYLAN PHARMS INC Labeling Approval
04/11/2019 MIFEPRISTONE
ANDA #091178
ORIG-1 MIFEPRISTONE GENBIOPRO Approval
04/11/2019 ACTEMRA
BLA #125276
SUPPL-120 TOCILIZUMAB GENENTECH Approval
04/11/2019 ACTEMRA
BLA #125276
SUPPL-121 TOCILIZUMAB GENENTECH Approval
04/11/2019 ACTEMRA
BLA #125472
SUPPL-37 TOCILIZUMAB GENENTECH Approval
04/11/2019 KEYTRUDA
BLA #125514
SUPPL-47 PEMBROLIZUMAB MERCK SHARP DOHME Approval
04/11/2019 REPATHA
BLA #125522
SUPPL-20 EVOLOCUMAB AMGEN INC Approval
04/11/2019 SIGNIFOR
NDA #200677
SUPPL-5 PASIREOTIDE DIASPARTATE NOVARTIS Labeling Approval
04/11/2019 SIGNIFOR LAR KIT
NDA #203255
SUPPL-7 PASIREOTIDE PAMOATE NOVARTIS PHARMS CORP Labeling Approval
04/11/2019 EPLERENONE
ANDA #203896
SUPPL-2 EPLERENONE MYLAN PHARMS INC Labeling Approval
04/11/2019 LEVOTHYROXINE SODIUM
NDA #210632
ORIG-1 LEVOTHYROXINE SODIUM FRESENIUS KABI USA Type 3 - New Dosage Form Approval
04/12/2019 BECONASE AQ
NDA #019389
SUPPL-34 BECLOMETHASONE DIPROPIONATE MONOHYDRATE GLAXOSMITHKLINE Labeling Approval
04/12/2019 LIPITOR
NDA #020702
SUPPL-73 ATORVASTATIN CALCIUM PFIZER Labeling Approval
04/12/2019 CYPROHEPTADINE HYDROCHLORIDE
ANDA #206676
ORIG-1 CYPROHEPTADINE HYDROCHLORIDE BEXIMCO PHARMS USA Approval
04/12/2019 DAUNORUBICIN HYDROCHLORIDE
ANDA #208759
ORIG-1 DAUNORUBICIN HYDROCHLORIDE HISUN PHARM HANGZHOU Approval
04/12/2019 BIMATOPROST
ANDA #210263
ORIG-1 BIMATOPROST ALEMBIC PHARMS LTD Approval
04/12/2019 BALVERSA
NDA #212018
ORIG-1 ERDAFITINIB JANSSEN BIOTECH Type 1 - New Molecular Entity Approval
04/15/2019 EXCEDRIN (MIGRAINE)
NDA #020802
SUPPL-33 ACETAMINOPHEN; ASPIRIN; CAFFEINE GLAXOSMITHKLINE CONS Labeling Approval
04/15/2019 VERDESO
NDA #021978
SUPPL-15 DESONIDE ALMIRALL Labeling Approval
04/15/2019 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091375
SUPPL-9 LEVOFLOXACIN HIKMA FARMACEUTICA Labeling Approval
04/15/2019 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091375
SUPPL-12 LEVOFLOXACIN HIKMA FARMACEUTICA Labeling Approval
04/15/2019 ACETAZOLAMIDE SODIUM
ANDA #206533
ORIG-1 ACETAZOLAMIDE ZYDUS PHARMS Approval
04/15/2019 DOXYCYCLINE HYCLATE
ANDA #209243
ORIG-1 DOXYCYCLINE HYCLATE APOTEX INC Approval
04/15/2019 CLOBAZAM
ANDA #210978
ORIG-1 CLOBAZAM TARO PHARM Approval
04/15/2019 FLUOXETINE HYDROCHLORIDE
ANDA #211653
ORIG-1 FLUOXETINE HYDROCHLORIDE LUPIN LTD Approval
04/15/2019 TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION
NDA #212020
ORIG-1 TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION EXELA PHARMA SCIENCE Type 5 - New Formulation or New Manufacturer Approval
04/16/2019 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020488
SUPPL-24 MAGNESIUM SULFATE HOSPIRA Labeling Approval
04/16/2019 CIPROFLOXACIN
ANDA #076717
SUPPL-6 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
04/16/2019 RIVASTIGMINE TARTRATE
ANDA #077131
SUPPL-6 RIVASTIGMINE TARTRATE SUN PHARM Labeling Approval
04/16/2019 RIVASTIGMINE TARTRATE
ANDA #077131
SUPPL-10 RIVASTIGMINE TARTRATE SUN PHARM Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #077652
SUPPL-8 LEVOFLOXACIN ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #077652
SUPPL-10 LEVOFLOXACIN ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #077652
SUPPL-14 LEVOFLOXACIN ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #077652
SUPPL-15 LEVOFLOXACIN ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 SUMATRIPTAN SUCCINATE
ANDA #077744
SUPPL-8 SUMATRIPTAN SUCCINATE MYLAN Labeling Approval
04/16/2019 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078252
SUPPL-30 CIPROFLOXACIN INFORLIFE Labeling Approval
04/16/2019 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078252
SUPPL-31 CIPROFLOXACIN INFORLIFE Labeling Approval
04/16/2019 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078431
SUPPL-9 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
04/16/2019 ROCURONIUM BROMIDE
ANDA #078717
SUPPL-23 ROCURONIUM BROMIDE TEVA PHARMS Labeling Approval
04/16/2019 BICALUTAMIDE
ANDA #079089
SUPPL-4 BICALUTAMIDE ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 BICALUTAMIDE
ANDA #079089
SUPPL-5 BICALUTAMIDE ZYDUS PHARMS USA INC Labeling Approval
04/16/2019 ROCURONIUM BROMIDE
ANDA #079199
SUPPL-9 ROCURONIUM BROMIDE MYLAN INSTITUTIONAL Labeling Approval
04/16/2019 ROCURONIUM BROMIDE
ANDA #079199
SUPPL-10 ROCURONIUM BROMIDE MYLAN INSTITUTIONAL Labeling Approval
04/16/2019 NEULASTA
BLA #125031
SUPPL-198 PEGFILGRASTIM AMGEN Approval
04/16/2019 BUSPIRONE HYDROCHLORIDE
ANDA #202087
SUPPL-1 BUSPIRONE HYDROCHLORIDE YILING PHARM LTD Labeling Approval
04/16/2019 TELMISARTAN
ANDA #202130
SUPPL-8 TELMISARTAN ALEMBIC PHARMS LTD Labeling Approval
04/16/2019 TELMISARTAN
ANDA #203325
SUPPL-3 TELMISARTAN ZYDUS PHARMS Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #203613
SUPPL-2 LEVOFLOXACIN JUBILANT GENERICS Labeling Approval
04/16/2019 LEVOFLOXACIN
ANDA #203613
SUPPL-3 LEVOFLOXACIN JUBILANT GENERICS Labeling Approval
04/16/2019 ROCURONIUM BROMIDE
ANDA #204679
SUPPL-4 ROCURONIUM BROMIDE WEST WARD PHARM CORP Labeling Approval
04/16/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #205153
SUPPL-1 DESIPRAMINE HYDROCHLORIDE ANI PHARMS INC Labeling Approval
04/16/2019 RIVASTIGMINE
ANDA #205622
SUPPL-1 RIVASTIGMINE MYLAN TECHNOLOGIES Labeling Approval
04/16/2019 ENTECAVIR
ANDA #206652
SUPPL-2 ENTECAVIR AMNEAL PHARMS Labeling Approval
04/16/2019 ENTECAVIR
ANDA #206652
SUPPL-3 ENTECAVIR AMNEAL PHARMS Labeling Approval
04/16/2019 ENTECAVIR
ANDA #206652
SUPPL-5 ENTECAVIR AMNEAL PHARMS Labeling Approval
04/16/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #206964
SUPPL-7 ASPIRIN; DIPYRIDAMOLE ANI PHARMS INC Labeling Approval
04/16/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #207433
SUPPL-3 DESIPRAMINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
04/16/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #208105
SUPPL-4 DESIPRAMINE HYDROCHLORIDE AMNEAL PHARMS CO Labeling Approval
04/16/2019 BUSPIRONE HYDROCHLORIDE
ANDA #208972
ORIG-1 BUSPIRONE HYDROCHLORIDE EPIC PHARMA LLC Approval
04/16/2019 EZETIMIBE AND SIMVASTATIN
ANDA #209222
SUPPL-2 EZETIMIBE; SIMVASTATIN ALKEM LABS LTD Labeling Approval
04/16/2019 NIFEDIPINE
ANDA #210838
ORIG-1 NIFEDIPINE SPIL Approval
04/16/2019 HYDROXYPROGESTERONE CAPROATE
ANDA #211070
ORIG-1 HYDROXYPROGESTERONE CAPROATE EUGIA PHARMA Approval
04/16/2019 HYDROXYPROGESTERONE CAPROATE
ANDA #211071
ORIG-1 HYDROXYPROGESTERONE CAPROATE EUGIA PHARMA Approval
04/16/2019 ACETAMINOPHEN
ANDA #211544
ORIG-1 ACETAMINOPHEN GRANULES INDIA LTD Approval
04/16/2019 UDENYCA
BLA #761039
SUPPL-1 PEGFILGRASTIM-CBQV COHERUS BIOSCIENCES INC Approval
04/17/2019 LEVOFLOXACIN
ANDA #078424
SUPPL-13 LEVOFLOXACIN LUPIN Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #078424
SUPPL-14 LEVOFLOXACIN LUPIN Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #078424
SUPPL-16 LEVOFLOXACIN LUPIN Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #078424
SUPPL-17 LEVOFLOXACIN LUPIN Labeling Approval
04/17/2019 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #090343
SUPPL-22 LEVOFLOXACIN INFORLIFE Labeling Approval
04/17/2019 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #090343
SUPPL-24 LEVOFLOXACIN INFORLIFE Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #090722
SUPPL-10 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #090722
SUPPL-11 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #090722
SUPPL-12 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #090722
SUPPL-13 LEVOFLOXACIN TORRENT PHARMS Labeling Approval
04/17/2019 LEVOFLOXACIN
ANDA #202590
SUPPL-6 LEVOFLOXACIN EMCURE PHARMS LTD Labeling Approval
04/17/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #203443
ORIG-2 MINOCYCLINE HYDROCHLORIDE MYLAN PHARMS INC Tentative Approval
04/17/2019 METFORMIN HYDROCHLORIDE
ANDA #206955
SUPPL-12 METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
04/17/2019 LOTEPREDNOL ETABONATE
ANDA #207609
ORIG-1 LOTEPREDNOL ETABONATE HI TECH Approval
04/17/2019 FLUTICASONE PROPIONATE
ANDA #208024
ORIG-1 FLUTICASONE PROPIONATE HI TECH Approval
04/17/2019 AZITHROMYCIN
ANDA #208250
ORIG-1 AZITHROMYCIN CSPC OUYI Approval
04/17/2019 AMPHETAMINE SULFATE
ANDA #211639
ORIG-1 AMPHETAMINE SULFATE AUROLIFE PHARMA LLC Approval
04/18/2019 BLINCYTO
BLA #125557
SUPPL-15 BLINATUMOMAB AMGEN Approval
04/18/2019 BLINCYTO
BLA #125557
SUPPL-16 BLINATUMOMAB AMGEN Approval
04/18/2019 NERLYNX
NDA #208051
SUPPL-3 NERATINIB MALEATE PUMA BIOTECH Labeling Approval
04/19/2019 KEYTRUDA
BLA #125514
SUPPL-54 PEMBROLIZUMAB MERCK SHARP DOHME 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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