Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214501


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NDA 214501 describes BRIVARACETAM, which is a drug marketed by Hainan Poly, Micro Labs, MSN, Shandong, Alkem Labs Ltd, Aurobindo Pharma, Lupin, Regcon Holdings, Zhejiang Poly Pharm, Apotex, Aurobindo Pharma Ltd, Centaur Pharms Pvt, Sciegen Pharms, Sunshine, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the BRIVARACETAM profile page.

The generic ingredient in BRIVARACETAM is brivaracetam. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 214501
Tradename:BRIVARACETAM
Applicant:Zydus Pharms
Ingredient:brivaracetam
Patents:0
Pharmacology for NDA: 214501
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 214501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVARACETAM brivaracetam TABLET;ORAL 214501 ANDA Zydus Pharmaceuticals USA Inc. 70710-1584 70710-1584-4 100 BLISTER PACK in 1 CARTON (70710-1584-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70710-1584-7)
BRIVARACETAM brivaracetam TABLET;ORAL 214501 ANDA Zydus Pharmaceuticals USA Inc. 70710-1584 70710-1584-6 60 TABLET, FILM COATED in 1 BOTTLE (70710-1584-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 3, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Oct 3, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 3, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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