← FDA Drug Approvals (Drugs@FDA)
TOPIRAMATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2025-09-02
Drug application
- FDA Application #
ANDA219564- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TOPIRAMATE
- Generic name
- TOPIRAMATE
- Active ingredients
- TOPIRAMATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AJANTA PHARMA LTD
- Manufacturer
- Ajanta Pharma USA Inc.
- First approval
- 2025-09-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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