Drugs@FDA: FDA-Approved Drugs

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

All Approvals and Tentative Approvals May 2021

All Approvals and Tentative Approvals
May 2021