APPLICATION
ANDA204982
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-25
LATEST ACTION
2026-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPrescription
PHENTERMINE HYDROCHLORIDE EQ 15MG BASE, TOPIRAMATE 92MG · CAPSULE, EXTENDED RELEASE · ORAL
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPrescription
PHENTERMINE HYDROCHLORIDE EQ 7.5MG BASE, TOPIRAMATE 46MG · CAPSULE, EXTENDED RELEASE · ORAL
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPrescription
PHENTERMINE HYDROCHLORIDE EQ 11.25MG BASE, TOPIRAMATE 69MG · CAPSULE, EXTENDED RELEASE · ORAL
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPrescription
PHENTERMINE HYDROCHLORIDE EQ 3.75MG BASE, TOPIRAMATE 23MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-05-01Labeling · Supplement 17 · standardAP
2026-05-01Labeling · Supplement 14 · standardAP
2025-04-17Labeling · Supplement 11 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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