MedPath
FDA Product

Briviact

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Briviact

50474-870

Regulatory Information

50474-870

NDA205838

C73594

May 24, 2023

USA

These highlights do not include all the information needed to use BRIVIACT safely and effectively. See full prescribing information for BRIVIACT. BRIVIACT (brivaracetam) tablets, for oral use, CV BRIVIACT (brivaracetam) oral solution, CV BRIVIACT (brivaracetam) injection, for intravenous use, CV Initial U.S. Approval: 2016

HUMAN PRESCRIPTION DRUG LABEL

19

Company Information

UCB, Inc.

028526403

Active Ingredients

brivaracetam

Quantity: 10 mg in 1 mL

Code: U863JGG2IA

Class Code: ACTIB

anhydrous citric acid

Code: XF417D3PSL

Class Code: IACT

sodium citrate, unspecified form

Code: 1Q73Q2JULR

Class Code: IACT

methylparaben

Code: A2I8C7HI9T

Class Code: IACT

carboxymethylcellulose sodium, unspecified

Code: K679OBS311

Class Code: IACT

sucralose

Code: 96K6UQ3ZD4

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

sorbitol

Code: 506T60A25R

Class Code: IACT

glycerin

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

brivaracetam

Code: U863JGG2IA

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