Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 2020

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 09, 2020.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2020 ALOXI
NDA #021372		 SUPPL-21 PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
04/01/2020 ALOXI
NDA #022233		 SUPPL-6 PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040104		 SUPPL-25 HYDROXYCHLOROQUINE SULFATE SANDOZ Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040133		 SUPPL-29 HYDROXYCHLOROQUINE SULFATE WATSON LABS Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040133		 SUPPL-30 HYDROXYCHLOROQUINE SULFATE WATSON LABS Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040150		 SUPPL-7 HYDROXYCHLOROQUINE SULFATE INVATECH Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040274		 SUPPL-13 HYDROXYCHLOROQUINE SULFATE MYLAN Labeling Approval
04/01/2020 ETHOSUXIMIDE
ANDA #040430		 SUPPL-13 ETHOSUXIMIDE BIONPHARMA INC Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040760		 SUPPL-6 HYDROXYCHLOROQUINE SULFATE HIKMA PHARMS Labeling Approval
04/01/2020 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-12 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
04/01/2020 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-12 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
04/01/2020 ESOMEPRAZOLE SODIUM
ANDA #203349		 ORIG-1 ESOMEPRAZOLE SODIUM GLAND PHARMA LTD Approval
04/01/2020 LAMOTRIGINE
ANDA #207763		 ORIG-1 LAMOTRIGINE ZYDUS PHARMS Approval
04/01/2020 AZITHROMYCIN
ANDA #209044		 SUPPL-7 AZITHROMYCIN SUNSHINE LAKE Manufacturing (CMC) Approval
04/01/2020 AZITHROMYCIN
ANDA #209045		 SUPPL-7 AZITHROMYCIN SUNSHINE LAKE Manufacturing (CMC) Approval
04/01/2020 ROSUVASTATIN CALCIUM
ANDA #210667		 ORIG-1 ROSUVASTATIN CALCIUM SUNSHINE LAKE Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #210959		 SUPPL-1 HYDROXYCHLOROQUINE SULFATE LAURUS LABS LTD Labeling Approval
04/01/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #210959		 SUPPL-5 HYDROXYCHLOROQUINE SULFATE LAURUS LABS LTD Labeling Approval
04/01/2020 DICLOFENAC SODIUM
ANDA #211253		 SUPPL-5 DICLOFENAC SODIUM PERRIGO UK FINCO Labeling Approval
04/02/2020 NEURONTIN
NDA #020235		 SUPPL-68 GABAPENTIN PFIZER PHARMS Labeling Approval
04/02/2020 NEURONTIN
NDA #020882		 SUPPL-49 GABAPENTIN PFIZER PHARMS Labeling Approval
04/02/2020 NEURONTIN
NDA #021129		 SUPPL-49 GABAPENTIN PARKE DAVIS Labeling Approval
04/02/2020 NEXAVAR
NDA #021923		 SUPPL-23 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
04/02/2020 TRAVATAN Z
NDA #021994		 SUPPL-13 TRAVOPROST NOVARTIS Labeling Approval
04/02/2020 HORIZANT
NDA #022399		 SUPPL-11 GABAPENTIN ENACARBIL ARBOR PHARMS LLC Labeling Approval
04/02/2020 GRALISE
NDA #022544		 SUPPL-26 GABAPENTIN ALMATICA Labeling Approval
04/02/2020 ROPINIROLE HYDROCHLORIDE
ANDA #079165		 SUPPL-4 ROPINIROLE HYDROCHLORIDE MLV Labeling Approval
04/02/2020 ROPINIROLE HYDROCHLORIDE
ANDA #079165		 SUPPL-5 ROPINIROLE HYDROCHLORIDE MLV Labeling Approval
04/02/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #091028		 SUPPL-5 OMEGA-3-ACID ETHYL ESTERS TEVA PHARMS USA Labeling Approval
04/02/2020 HEMANGEOL
NDA #205410		 SUPPL-5 PROPRANOLOL HYDROCHLORIDE PIERRE FABRE DERMA Labeling Approval
04/02/2020 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207667		 SUPPL-1 METHYLPREDNISOLONE SODIUM SUCCINATE AUROBINDO PHARMA LTD Labeling Approval
04/02/2020 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207667		 SUPPL-2 METHYLPREDNISOLONE SODIUM SUCCINATE AUROBINDO PHARMA LTD Labeling Approval
04/02/2020 CINACALCET HYDROCHLORIDE
ANDA #208915		 SUPPL-2 CINACALCET HYDROCHLORIDE CIPLA Labeling Approval
04/02/2020 BALVERSA
NDA #212018		 SUPPL-1 ERDAFITINIB JANSSEN BIOTECH Labeling Approval
04/02/2020 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #212060		 ORIG-1 HEPARIN SODIUM NANJING KING-FRIEND Approval
04/03/2020 REQUIP
NDA #020658		 SUPPL-37 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
04/03/2020 MIRAPEX
NDA #020667		 SUPPL-41 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
04/03/2020 CYCLOSET
NDA #020866		 SUPPL-13 BROMOCRIPTINE MESYLATE VEROSCIENCE Labeling Approval
04/03/2020 LYRICA
NDA #021446		 SUPPL-40 PREGABALIN PF PRISM CV Labeling Approval
04/03/2020 NEUPRO
NDA #021829		 SUPPL-19 ROTIGOTINE UCB INC Labeling Approval
04/03/2020 LYRICA
NDA #022488		 SUPPL-17 PREGABALIN PF PRISM CV Labeling Approval
04/03/2020 TOBRAMYCIN SULFATE
NDA #050789		 SUPPL-6 TOBRAMYCIN SULFATE FRESENIUS KABI USA Labeling Approval
04/03/2020 CLINDAMYCIN PHOSPHATE
ANDA #065049		 SUPPL-16 CLINDAMYCIN PHOSPHATE PERRIGO NEW YORK Labeling Approval
04/03/2020 CLINDAMYCIN PHOSPHATE
ANDA #065049		 SUPPL-23 CLINDAMYCIN PHOSPHATE PERRIGO NEW YORK Labeling Approval
04/03/2020 TIMOLOL MALEATE
ANDA #074746		 SUPPL-16 TIMOLOL MALEATE PACIFIC PHARMA Labeling Approval
04/03/2020 TIMOLOL MALEATE
ANDA #074747		 SUPPL-17 TIMOLOL MALEATE PACIFIC PHARMA Labeling Approval
04/03/2020 TIMOLOL MALEATE
ANDA #075163		 SUPPL-4 TIMOLOL MALEATE HI TECH PHARMA Labeling Approval
04/03/2020 TIMOLOL MALEATE
ANDA #075411		 SUPPL-28 TIMOLOL MALEATE APOTEX INC Labeling Approval
04/03/2020 TIMOLOL MALEATE
ANDA #075412		 SUPPL-30 TIMOLOL MALEATE APOTEX INC Labeling Approval
04/03/2020 MOMETASONE FUROATE
ANDA #076591		 SUPPL-14 MOMETASONE FUROATE ANDA REPOSITORY Labeling Approval
04/03/2020 ROPINIROLE HYDROCHLORIDE
ANDA #079229		 SUPPL-2 ROPINIROLE HYDROCHLORIDE ORCHID HLTHCARE Labeling Approval
04/03/2020 POLYETHYLENE GLYCOL 3350
ANDA #091077		 SUPPL-8 POLYETHYLENE GLYCOL 3350 NOVEL LABS INC Labeling Approval
04/03/2020 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569		 SUPPL-9 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
04/03/2020 NIKKI
ANDA #201661		 SUPPL-10 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Manufacturing (CMC) Approval
04/03/2020 DAPTOMYCIN
NDA #208385		 SUPPL-5 DAPTOMYCIN SAGENT PHARMS INC Labeling Approval
04/03/2020 LYRICA CR
NDA #209501		 SUPPL-3 PREGABALIN PF PRISM CV Labeling Approval
04/03/2020 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #210293		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BIONPHARMA INC Approval
04/03/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #210653		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE TULEX PHARMS INC Approval
04/03/2020 MEMANTINE HYDROCHLORIDE
ANDA #212947		 ORIG-1 MEMANTINE HYDROCHLORIDE NINGBO Approval
04/03/2020 REBLOZYL
BLA #761136		 ORIG-2 LUSPATERCEPT-AAMT CELGENE CORP Approval
04/06/2020 ALEVE-D SINUS & COLD
NDA #021076		 SUPPL-16 NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE BAYER Labeling Approval
04/06/2020 FORTEO
NDA #021318		 SUPPL-53 TERIPARATIDE LILLY Labeling Approval
04/06/2020 ELOXATIN
NDA #021492		 SUPPL-16 OXALIPLATIN SANOFI AVENTIS US Labeling Approval
04/06/2020 ELOXATIN
NDA #021759		 SUPPL-23 OXALIPLATIN SANOFI AVENTIS US Labeling Approval
04/06/2020 BUMETANIDE
ANDA #074700		 SUPPL-23 BUMETANIDE SANDOZ Labeling Approval
04/06/2020 MOMETASONE FUROATE
ANDA #076679		 SUPPL-16 MOMETASONE FUROATE TARO Labeling Approval
04/06/2020 LEVOFLOXACIN
ANDA #076710		 SUPPL-15 LEVOFLOXACIN DR REDDYS LABS INC Labeling Approval
04/06/2020 LEVOFLOXACIN
ANDA #076890		 SUPPL-16 LEVOFLOXACIN CIPLA LTD Labeling Approval
04/06/2020 LEVOFLOXACIN
ANDA #076890		 SUPPL-17 LEVOFLOXACIN CIPLA LTD Labeling Approval
04/06/2020 LEVOFLOXACIN
ANDA #077438		 SUPPL-19 LEVOFLOXACIN SANDOZ Labeling Approval
04/06/2020 STELARA
BLA #125261		 SUPPL-153 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
04/06/2020 MEGESTROL ACETATE
ANDA #203960		 SUPPL-2 MEGESTROL ACETATE HI TECH Labeling Approval
04/06/2020 IBUPROFEN
ANDA #204469		 SUPPL-3 IBUPROFEN STRIDES PHARMA Manufacturing (CMC) Approval
04/06/2020 PERPHENAZINE
ANDA #205232		 ORIG-1 PERPHENAZINE ZYDUS PHARMS Approval
04/06/2020 ALEVE PM
NDA #205352		 SUPPL-14 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
04/06/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #209467		 SUPPL-2 SUCCINYLCHOLINE CHLORIDE ZYDUS PHARMS Labeling Approval
04/06/2020 CHOLESTYRAMINE
ANDA #211119		 ORIG-1 CHOLESTYRAMINE AJANTA PHARMA LTD Approval
04/07/2020 LUPRON DEPOT-PED
NDA #020263		 SUPPL-46 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
04/07/2020 SOLIRIS
BLA #125166		 SUPPL-432 ECULIZUMAB ALEXION PHARM Approval
04/07/2020 PURIXAN
NDA #205919		 SUPPL-4 MERCAPTOPURINE NOVA LABS LTD Labeling Approval
04/08/2020 BRAFTOVI
NDA #210496		 SUPPL-6 ENCORAFENIB ARRAY BIOPHARMA INC Efficacy Approval

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