← FDA DRUG APPROVALS

FDA NDA · NDA022580

PHENTERMINE AND TOPIRAMATE

Sponsor: VIVUS LLC

APPLICATION
NDA022580
TYPE
NDA
ORIGINAL APPROVAL
2012-07-17
LATEST ACTION
2026-06-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QSYMIA · ReferencePrescription
PHENTERMINE HYDROCHLORIDE EQ 15MG BASE, TOPIRAMATE 92MG · CAPSULE, EXTENDED RELEASE · ORAL
QSYMIA · ReferencePrescription
PHENTERMINE HYDROCHLORIDE EQ 7.5MG BASE, TOPIRAMATE 46MG · CAPSULE, EXTENDED RELEASE · ORAL
QSYMIA · ReferencePrescription
PHENTERMINE HYDROCHLORIDE EQ 11.25MG BASE, TOPIRAMATE 69MG · CAPSULE, EXTENDED RELEASE · ORAL
QSYMIA · ReferencePrescription
PHENTERMINE HYDROCHLORIDE EQ 3.75MG BASE, TOPIRAMATE 23MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-06-29REMS · Supplement 32 — Letter ↗AP
2026-03-06Labeling · Supplement 31 · 901 required — Letter ↗AP
2025-07-11REMS · Supplement 29 — Label ↗AP
2024-11-19REMS · Supplement 26 — Label ↗AP
2024-09-13Efficacy · Supplement 25 · standard — Label ↗AP
2024-02-06REMS · Supplement 24 — Letter ↗AP
2023-06-28Labeling · Supplement 23 · standard — Letter ↗AP
2023-05-09REMS · Supplement 22 — Letter ↗AP
2022-06-24Efficacy · Supplement 21 · standard — Letter ↗AP
2022-03-08REMS · Supplement 20 — Letter ↗AP
2021-03-31REMS · Supplement 19 — Letter ↗AP
2020-10-19Labeling · Supplement 17 · standard — Label ↗AP
2018-03-23Labeling · Supplement 16 · standard — Label ↗AP
2017-01-27Manufacturing (CMC) · Supplement 14 · standardAP
2014-09-26REMS · Supplement 10 — Label ↗AP
2014-09-26Labeling · Supplement 11 · standard — Label ↗AP
2014-09-26Labeling · Supplement 12 · standard — Letter ↗AP
2013-10-17Manufacturing (CMC) · Supplement 7 · standardAP
2013-09-24Manufacturing (CMC) · Supplement 8 · standardAP
2013-04-16REMS · Supplement 4 — Label ↗AP
2013-03-19Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
2012-11-01REMS · Supplement 1 — Letter ↗AP
2012-07-17Type 4 - New Combination · Original · standard — Label ↗AP
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