Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
January 2018

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 30, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
01/09/2018 BALCOLTRA
NDA #208612
ETHINYL ESTRADIOL; LEVONORGESTREL Type 3 - New Dosage Form Standard AVION PHARMS
01/17/2018 CABAZITAXEL INJECTION
NDA #207970
CABAZITAXEL Type 5 - New Formulation or New Manufacturer Standard ACTAVIS LLC
01/18/2018 TIGECYCLINE
NDA #208744
TIGECYCLINE Type 5 - New Formulation or New Manufacturer Standard ACCORD HLTHCARE INC
01/25/2018 LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
NDA #205493
LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE Type 4 - New Combination Standard MICRO LABS LTD
01/26/2018 LUTATHERA
NDA #208700
LUTETIUM DOTATATE LU-177 Type 1 - New Molecular Entity Priority AAA USA INC
01/26/2018 FIRVANQ KIT
NDA #208910
VANCOMYCIN HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Priority RXMTM THERAPS LLC
01/26/2018 ATROPINE SULFATE
NDA #209260
ATROPINE SULFATE Standard FRESENIUS KABI USA
01/26/2018 KAPSPARGO SPRINKLE
NDA #210428
METOPROLOL SUCCINATE Type 3 - New Dosage Form Standard SPIL

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