Drugs@FDA: FDA-Approved Drugs

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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.

 

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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

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