Last Updated: November 13, 2026

Details for New Drug Application (NDA): 219766

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NDA 219766 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, Breckenridge, 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 219766

Tradename:	BRIVARACETAM
Applicant:	Shandong
Ingredient:	brivaracetam
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Jul 13, 2026	TE:	AP	RLD:	No

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