Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 2021

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 May 07, 2021.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/03/2021 PLAQUENIL
NDA #009768
SUPPL-53 HYDROXYCHLOROQUINE SULFATE CONCORDIA Labeling Approval
05/03/2021 OLANZAPINE
ANDA #076534
SUPPL-4 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
05/03/2021 OXYCODONE AND ASPIRIN
ANDA #090084
SUPPL-11 ASPIRIN; OXYCODONE HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
05/03/2021 NITROGLYCERIN
ANDA #209779
ORIG-1 NITROGLYCERIN RUBICON Approval
05/03/2021 BUPRENORPHINE
ANDA #210162
ORIG-1 BUPRENORPHINE MYLAN TECHNOLOGIES Approval
05/03/2021 SERTRALINE HYDROCHLORIDE
ANDA #214790
ORIG-1 SERTRALINE HYDROCHLORIDE ASCENT PHARMS INC Approval
05/03/2021 NIVESTYM
BLA #761080
SUPPL-7 FILGRASTIM-AAFI HOSPIRA INC Approval
05/03/2021 ENSPRYNG
BLA #761149
SUPPL-2 SATRALIZUMAB GENENTECH Approval
05/04/2021 OXYCODONE AND ASPIRIN
ANDA #040260
SUPPL-19 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE SUN PHARM INDUSTRIES Labeling Approval
05/04/2021 OXYCODONE AND ASPIRIN
ANDA #087794
SUPPL-31 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE SUN PHARM INDUSTRIES Labeling Approval
05/04/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #091633
SUPPL-13 HYDROCODONE BITARTRATE; IBUPROFEN SUN PHARM INDS INC Labeling Approval
05/04/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266
ORIG-3 DEXMETHYLPHENIDATE HYDROCHLORIDE MYLAN Approval
05/04/2021 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #213099
ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE ALEMBIC PHARMS LTD Approval
05/04/2021 SODIUM ACETATE
ANDA #214805
ORIG-1 SODIUM ACETATE MILLA PHARMS Approval
05/05/2021 GANCICLOVIR SODIUM
ANDA #076222
SUPPL-6 GANCICLOVIR SODIUM WEST-WARD PHARMS INT Labeling Approval
05/05/2021 KEYTRUDA
BLA #125514
SUPPL-97 PEMBROLIZUMAB MERCK SHARP DOHME Approval
05/05/2021 IRESSA
NDA #206995
SUPPL-4 GEFITINIB ASTRAZENECA Labeling Approval
05/05/2021 DAPTOMYCIN
NDA #209949
SUPPL-6 DAPTOMYCIN XELLIA PHARMS APS Efficacy Approval
05/05/2021 DAPTOMYCIN
NDA #209949
SUPPL-7 DAPTOMYCIN XELLIA PHARMS APS Efficacy Approval
05/05/2021 UPNEEQ
NDA #212520
SUPPL-4 OXYMETAZOLINE HYDROCHLORIDE RVL PHARMS Labeling Approval
05/05/2021 DROXIDOPA
ANDA #214543
ORIG-1 DROXIDOPA BLUEPHARMA Approval
05/06/2021 ONPATTRO
NDA #210922
SUPPL-9 PATISIRAN SODIUM ALNYLAM PHARMS INC Labeling Approval

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