MedPath
FDA Product

Briviact

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

Basic Information

Briviact

50474-370

Regulatory Information

50474-370

NDA205836

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

croscarmellose sodium

Code: M28OL1HH48

Class Code: IACT

betadex

Code: JV039JZZ3A

Class Code: IACT

brivaracetam

Quantity: 10 mg in 1 1

Code: U863JGG2IA

Class Code: ACTIB

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

talc

Code: 7SEV7J4R1U

Class Code: IACT

anhydrous lactose

Code: 3SY5LH9PMK

Class Code: IACT

polyethylene glycol 3350

Code: G2M7P15E5P

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

polyvinyl alcohol, unspecified

Code: 532B59J990

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

brivaracetam

Code: U863JGG2IA

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