General MedicationsTABLETGeneric
BRIVARACETAM
BRIVARACETAM
Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview BRIVARACETAM is listed in Drugs@FDA under application 219583 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BRIVARACETAM Form and strength TABLET - 25MG Sponsor SHANDONG NEW TIME PHARMACEUTICAL CO LTD Submission history Latest submission status date: 2026-02-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview BRIVARACETAM is listed in Drugs@FDA under application 219583 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BRIVARACETAM Form and strength TABLET - 25MG Sponsor SHANDONG NEW TIME PHARMACEUTICAL CO LTD Submission history Latest submission status date: 2026-02-26 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.