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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 2017

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 04, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/02/2017 ASCOR
NDA #209112		 ASCORBIC ACID Type 7 - Drug Already Marketed without Approved NDA Standard MCGUFF
10/06/2017 ZILRETTA
NDA #208845		 TRIAMCINOLONE ACETONIDE Type 5 - New Formulation or New Manufacturer Standard PACIRA PHARMS INC
10/11/2017 LYRICA CR
NDA #209501		 PREGABALIN Type 5 - New Formulation or New Manufacturer Standard UPJOHN
10/20/2017 BYDUREON BCISE
NDA #209210		 EXENATIDE SYNTHETIC Type 3 - New Dosage Form Standard ASTRAZENECA AB
10/20/2017 DAPTOMYCIN
NDA #209949		 DAPTOMYCIN Type 5 - New Formulation or New Manufacturer Standard XELLIA PHARMS APS
10/25/2017 VARUBI
NDA #208399		 ROLAPITANT HYDROCHLORIDE Type 3 - New Dosage Form Standard TERSERA
10/27/2017 ATAZANAVIR AND RITONAVIR
NDA #206451		 ATAZANAVIR; RITONAVIR Type 4 - New Combination Priority CIPLA
10/31/2017 CALQUENCE
NDA #210259		 ACALABRUTINIB Type 1 - New Molecular Entity Priority ASTRAZENECA
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