Last Updated: October 24, 2026

Details for New Drug Application (NDA): 220288

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NDA 220288 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, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in nineteen NDAs. It is available from sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.

Summary for 220288

Tradename:	BRIVARACETAM
Applicant:	Aurobindo Pharma
Ingredient:	brivaracetam
Patents:	0

Pharmacology for NDA: 220288

Mechanism of Action	Epoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 220288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIVARACETAM	brivaracetam	SOLUTION;ORAL	220288	ANDA	Aurobindo Pharma Limited	59651-995	59651-995-03	300 mL in 1 BOTTLE, PLASTIC (59651-995-03)

Profile for product number 001

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

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