General MedicationsORALStandard
BRIVARACETAM
BRIVARACETAM
Standard Dose
10MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BRIVARACETAM is listed in Drugs@FDA under application 219772 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BRIVARACETAM Form and strength SOLUTION;ORAL - 10MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-02-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview BRIVARACETAM is listed in Drugs@FDA under application 219772 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BRIVARACETAM Form and strength SOLUTION;ORAL - 10MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-02-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.