Last Updated: May 10, 2026

Details for New Drug Application (NDA): 218494

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NDA 218494 describes BRIVARACETAM, which is a drug marketed by Hainan Poly, Micro Labs, MSN, Alkem Labs Ltd, Lupin, Regcon Holdings, Zhejiang Poly Pharm, Apotex, Aurobindo Pharma Ltd, Centaur Pharms Pvt, Lupin Ltd, Sunshine, and Zydus Pharms, and is included in fifteen NDAs. It is available from fourteen suppliers. Additional details are available on the BRIVARACETAM profile page.

The generic ingredient in BRIVARACETAM is brivaracetam. Fifteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.

Summary for 218494

Tradename:	BRIVARACETAM
Applicant:	Zhejiang Poly Pharm
Ingredient:	brivaracetam
Patents:	0

Pharmacology for NDA: 218494

Mechanism of Action	Epoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 218494

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIVARACETAM	brivaracetam	SOLUTION;ORAL	218494	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1074	0121-1074-10	1 BOTTLE in 1 CARTON (0121-1074-10) / 300 mL in 1 BOTTLE
BRIVARACETAM	brivaracetam	SOLUTION;ORAL	218494	ANDA	Zhejiang Poly Pharm. Co., Ltd.	72673-031	72673-031-10	1 BOTTLE in 1 CARTON (72673-031-10) / 300 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Feb 23, 2026	TE:	AA	RLD:	No

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