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FDA NDA · NDA020844

TOPAMAX

topiramate

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020844
TYPE
NDA
ORIGINAL APPROVAL
1998-10-26
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

TOPAMAX SPRINKLE · ReferenceDiscontinued
TOPIRAMATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TOPAMAX · ReferencePrescription
TOPIRAMATE 15MG · CAPSULE · ORAL
TOPAMAX · ReferencePrescription
TOPIRAMATE 25MG · CAPSULE · ORAL

Approval history

2026-03-06Labeling · Supplement 59 · standard — Letter ↗AP
2025-03-12Labeling · Supplement 58 · standard — Letter ↗AP
2023-05-03Labeling · Supplement 56 · standard — Letter ↗AP
2022-10-20Labeling · Supplement 55 · standard — Letter ↗AP
2022-01-13Efficacy · Supplement 53 · standard — Letter ↗AP
2021-06-30Labeling · Supplement 54 · standard — Label ↗AP
2020-06-08Labeling · Supplement 52 · standard — Letter ↗AP
2019-05-02Labeling · Supplement 51 · standard — Label ↗AP
2018-12-27Labeling · Supplement 50 · standard — Label ↗AP
2018-06-19Labeling · Supplement 49 · standard — Letter ↗AP
2017-05-12Labeling · Supplement 48 · standard — Label ↗AP
2014-12-18Labeling · Supplement 46 · standard — Label ↗AP
2014-10-21Labeling · Supplement 45 · standard — Letter ↗AP
2014-03-28Efficacy · Supplement 43 · standard — Label ↗AP
2014-01-29Labeling · Supplement 44 · standard — Letter ↗AP
2012-10-29Labeling · Supplement 41 · standard — Label ↗AP
2011-07-15Efficacy · Supplement 36 · standard — Letter ↗AP
2011-06-27REMS · Supplement 38AP
2011-03-04Labeling · Supplement 37 · standardAP
2011-03-04Labeling · Supplement 35 · standard — Letter ↗AP
2009-12-22Efficacy · Supplement 31 · priority — Label ↗AP
2009-12-22Labeling · Supplement 11 · standard — Label ↗AP
2009-12-22Labeling · Supplement 26 · standard — Letter ↗AP
2009-12-22Labeling · Supplement 27 · standard — Label ↗AP
2009-04-23Labeling · Supplement 34 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 32 · 901 required — Letter ↗AP
2009-04-22Labeling · Supplement 30 · standard — Label ↗AP
2006-10-19Labeling · Supplement 24 · standard — Letter ↗AP
2005-06-29Efficacy · Supplement 15 · standard — Label ↗AP
2005-06-29Labeling · Supplement 22 · standard — Label ↗AP
2004-08-11Labeling · Supplement 21 · standard — Letter ↗AP
2004-08-11Efficacy · Supplement 19 · standard — Label ↗AP
2003-12-16Labeling · Supplement 16 · standard — Letter ↗AP
2003-12-16Efficacy · Supplement 14 · standard — Label ↗AP
2003-12-16Labeling · Supplement 6 · standard — Label ↗AP
2003-06-12Labeling · Supplement 17 · standard — Letter ↗AP
2003-06-03Labeling · Supplement 12 · standard — Letter ↗AP
2003-04-15Labeling · Supplement 18 · standard — Letter ↗AP
2003-04-15Labeling · Supplement 20 · standard — Letter ↗AP
2002-11-26Labeling · Supplement 13 · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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