← FDA Drug Approvals (Drugs@FDA)
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2025-06-12
Drug application
- FDA Application #
ANDA208175- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
- Generic name
- PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE
- Active ingredients
- PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- DR REDDYS LABS SA
- Manufacturer
- Dr.Reddys Laboratories Inc
- First approval
- 2025-06-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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