Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
July 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 July 03, 2020.

Month: Year:

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
07/01/2020	PRADAXA NDA #022512	SUPPL-39	DABIGATRAN ETEXILATE MESYLATE	BOEHRINGER INGELHEIM	Labeling	Approval
07/01/2020	BUMETANIDE ANDA #074332	SUPPL-15	BUMETANIDE	HOSPIRA	Labeling	Approval
07/01/2020	NATPARA BLA #125511	SUPPL-20	PARATHYROID HORMONE	NPS PHARMS INC		Approval
07/01/2020	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-21	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
07/01/2020	DOXEPIN HYDROCHLORIDE ANDA #213063	ORIG-1	DOXEPIN HYDROCHLORIDE	TARO PHARM INDS LTD		Approval
07/01/2020	FUROSEMIDE ANDA #213902	ORIG-1	FUROSEMIDE	GLAND PHARMA LTD		Approval
07/02/2020	BYFAVO NDA #212295	ORIG-1	REMIMAZOLAM	COSMO TECHNOLOGIES LTD	Type 1 - New Molecular Entity and Type 4 - New Combination	Approval

All Approvals and Tentative Approvals July 2020

All Approvals and Tentative Approvals
July 2020