General MedicationsORALStandard
TOPIRAMATE
TOPIRAMATE
Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TOPIRAMATE is listed in Drugs@FDA under application 219564 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TOPIRAMATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 25MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2025-09-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview TOPIRAMATE is listed in Drugs@FDA under application 219564 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TOPIRAMATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 25MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2025-09-02 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.