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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