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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