Last Updated: August 3, 2026

Details for New Drug Application (NDA): 220385

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NDA 220385 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, 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 220385

Tradename:	BRIVARACETAM
Applicant:	Regcon Holdings
Ingredient:	brivaracetam
Patents:	0

Pharmacology for NDA: 220385

Mechanism of Action	Epoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 220385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIVARACETAM	brivaracetam	SOLUTION;ORAL	220385	ANDA	Florida Pharmaceutical Products, LLC	71921-410	71921-410-72	1 BOTTLE in 1 CARTON (71921-410-72) / 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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