Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214880

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NDA 214880 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 214880

Tradename:	BRIVARACETAM
Applicant:	Micro Labs
Ingredient:	brivaracetam
Patents:	0

Pharmacology for NDA: 214880

Mechanism of Action	Epoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 214880

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIVARACETAM	brivaracetam	SOLUTION;INTRAVENOUS	214880	ANDA	Micro Labs Limited	42571-370	42571-370-99	10 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92)

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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