Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
August 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 December 05, 2019.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
08/01/2017 IDHIFA
NDA #209606
ENASIDENIB MESYLATE Type 1 - New Molecular Entity Priority CELGENE CORP
08/02/2017 DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA #209670
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE Type 4 - New Combination Priority MYLAN PHARMS INC
08/03/2017 QVAR REDIHALER
NDA #207921
BECLOMETHASONE DIPROPIONATE Type 5 - New Formulation or New Manufacturer Standard NORTON WATERFORD
08/03/2017 MAVYRET
NDA #209394
GLECAPREVIR; PIBRENTASVIR Type 1 - New Molecular Entity and Type 4 - New Combination Priority ABBVIE INC
08/03/2017 VYXEOS
NDA #209401
CYTARABINE; DAUNORUBICIN Type 4 - New Combination Priority CELATOR PHARMS
08/03/2017 GEMCITABINE HYDROCHLORIDE
NDA #209604
GEMCITABINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard ACCORD HLTHCARE
08/04/2017 CAROSPIR
NDA #209478
SPIRONOLACTONE Type 3 - New Dosage Form Standard CMP DEV LLC
08/04/2017 NIKITA
NDA #209875
PITAVASTATIN SODIUM Type 2 - New Active Ingredient Standard LUPIN LTD
08/17/2017 LYNPARZA
NDA #208558
OLAPARIB Type 3 - New Dosage Form Priority ASTRAZENECA PHARMS
08/17/2017 DRAX EXAMETAZIME
NDA #208870
TECHNETIUM TC-99M EXAMETAZIME KIT Type 5 - New Formulation or New Manufacturer Standard JUBILANT DRAXIMAGE
08/17/2017 BESPONSA
BLA #761040
INOTUZUMAB OZOGAMICIN WYETH PHARMS INC
08/18/2017 DUZALLO
NDA #209203
ALLOPURINOL; LESINURAD Type 4 - New Combination Standard IRONWOOD PHARMS INC
08/18/2017 DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA #209618
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Type 4 - New Combination Priority AUROBINDO PHARMA LTD
08/22/2017 CARBON DIOXIDE, USP
NDA #210816
CARBON DIOXIDE Medical Gas Unknown LISS AMERICA LLC
08/24/2017 GOCOVRI
NDA #208944
AMANTADINE HYDROCHLORIDE Type 3 - New Dosage Form Standard ADAMAS PHARMA
08/25/2017 CYLTEZO
BLA #761058
ADALIMUMAB-ADBM BOEHRINGER INGELHEIM
08/29/2017 BENZNIDAZOLE
NDA #209570
BENZNIDAZOLE Type 1 - New Molecular Entity Priority CHEMO RESEARCH SL
08/29/2017 VABOMERE
NDA #209776
MEROPENEM; VABORBACTAM Type 1 - New Molecular Entity and Type 4 - New Combination Priority REMPEX PHARMS
08/30/2017 AUSTEDO
NDA #209885
DEUTETRABENAZINE Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Priority TEVA BRANDED PHARM

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