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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
December 2019

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

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 03, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
12/06/2019 AVSOLA
BLA #761086		 INFLIXIMAB-AXXQ AMGEN INC
12/12/2019 VYONDYS 53
NDA #211970		 GOLODIRSEN Type 1 - New Molecular Entity Priority SAREPTA THERAPS INC
12/13/2019 NOURESS
NDA #212535		 CYSTEINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Priority BAXTER HLTHCARE CORP
12/18/2019 ARAZLO
NDA #211882		 TAZAROTENE Type 5 - New Formulation or New Manufacturer Standard BAUSCH
12/18/2019 PADCEV
BLA #761137		 ENFORTUMAB VEDOTIN-EJFV ASTELLAS
12/19/2019 CONJUPRI
NDA #212895		 LEVAMLODIPINE MALEATE Type 2 - New Active Ingredient and Type 3 - New Dosage Form Standard CSPC OUYI
12/20/2019 GENOSYL
NDA #202860		 NITRIC OXIDE Type 5 - New Formulation or New Manufacturer Standard VERO BIOTECH INC
12/20/2019 CAPLYTA
NDA #209500		 LUMATEPERONE TOSYLATE Type 1 - New Molecular Entity Standard INTRA-CELLULAR
12/20/2019 TISSUEBLUE
NDA #209569		 BRILLIANT BLUE G Type 1 - New Molecular Entity Priority DUTCH OPHTHALMIC
12/20/2019 DAYVIGO
NDA #212028		 LEMBOREXANT Type 1 - New Molecular Entity Standard EISAI INC
12/20/2019 ENHERTU
BLA #761139		 FAM-TRASTUZUMAB DERUXTECAN-NXKI DAIICHI SANKYO
12/23/2019 UBRELVY
NDA #211765		 UBROGEPANT Type 1 - New Molecular Entity Standard ABBVIE
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