Last Updated: May 3, 2026

Details for New Drug Application (NDA): 218249

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NDA 218249 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 thirteen suppliers. Additional details are available on the BRIVARACETAM profile page.

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

Summary for 218249

Tradename:	BRIVARACETAM
Applicant:	Hainan Poly
Ingredient:	brivaracetam
Patents:	0

Pharmacology for NDA: 218249

Mechanism of Action	Epoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 218249

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIVARACETAM	brivaracetam	SOLUTION;INTRAVENOUS	218249	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1075	0121-1075-02	10 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55)
BRIVARACETAM	brivaracetam	SOLUTION;INTRAVENOUS	218249	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-420	14335-420-10	10 VIAL, GLASS in 1 CARTON (14335-420-10) / 5 mL in 1 VIAL, GLASS (14335-420-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Feb 23, 2026	TE:	AP	RLD:	No

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