Basic Information
Briviact
50474-470
Regulatory Information
50474-470
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
028526403
Active Ingredients
lactose monohydrate
Code: EWQ57Q8I5X
Class Code: IACT
betadex
Code: JV039JZZ3A
Class Code: IACT
croscarmellose sodium
Code: M28OL1HH48
Class Code: IACT
polyvinyl alcohol, unspecified
Code: 532B59J990
Class Code: IACT
anhydrous lactose
Code: 3SY5LH9PMK
Class Code: IACT
magnesium stearate
Code: 70097M6I30
Class Code: IACT
talc
Code: 7SEV7J4R1U
Class Code: IACT
ferric oxide yellow
Code: EX438O2MRT
Class Code: IACT
polyethylene glycol 3350
Code: G2M7P15E5P
Class Code: IACT
ferrosoferric oxide
Code: XM0M87F357
Class Code: IACT
titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
brivaracetam
Code: U863JGG2IA