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FDA NDA · NDA020505

TOPAMAX

topiramate

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020505
TYPE
NDA
ORIGINAL APPROVAL
1996-12-24
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

TOPAMAX · ReferencePrescription
TOPIRAMATE 50MG · TABLET · ORAL
TOPAMAXDiscontinued
TOPIRAMATE 300MG · TABLET · ORAL
TOPAMAX · ReferencePrescription
TOPIRAMATE 100MG · TABLET · ORAL
TOPAMAXDiscontinued
TOPIRAMATE 400MG · TABLET · ORAL
TOPAMAX · ReferencePrescription
TOPIRAMATE 25MG · TABLET · ORAL
TOPAMAX · ReferencePrescription
TOPIRAMATE 200MG · TABLET · ORAL

Approval history

2026-03-06Labeling · Supplement 68 · standardLetterAP
2025-03-12Labeling · Supplement 67 · standardLetterAP
2023-05-03Labeling · Supplement 65 · standardLabelAP
2022-10-20Labeling · Supplement 64 · standardLetterAP
2022-01-13Efficacy · Supplement 62 · standardLetterAP
2021-06-30Labeling · Supplement 63 · standardLabelAP
2020-06-08Labeling · Supplement 61 · standardLetterAP
2019-05-02Labeling · Supplement 60 · standardLabelAP
2018-12-27Labeling · Supplement 59 · standardLabelAP
2018-06-19Labeling · Supplement 58 · standardLetterAP
2017-05-12Labeling · Supplement 57 · standardLabelAP
2015-05-11Manufacturing (CMC) · Supplement 56 · standardAP
2014-12-18Labeling · Supplement 55 · standardLabelAP
2014-10-21Labeling · Supplement 54 · standardLetterAP
2014-03-28Efficacy · Supplement 52 · standardLetterAP
2014-01-29Labeling · Supplement 53 · standardLabelAP
2013-07-25Manufacturing (CMC) · Supplement 51 · standardAP
2012-10-29Labeling · Supplement 50 · standardLetterAP
2011-07-15Efficacy · Supplement 42 · standardLabelAP
2011-06-27REMS · Supplement 46AP
2011-03-04Labeling · Supplement 40 · standardLabelAP
2011-03-04Labeling · Supplement 45 · standardLabelAP
2009-12-22Labeling · Supplement 32 · standardLetterAP
2009-12-22Labeling · Supplement 14 · standardLetterAP
2009-12-22Efficacy · Supplement 37 · priorityPediatric Medical ReviewAP
2009-12-22Labeling · Supplement 31 · standardLabelAP
2009-04-23Labeling · Supplement 38 · 901 requiredLetterAP
2009-04-23Labeling · Supplement 39 · standardLabelAP
2009-04-22Labeling · Supplement 36 · standardLabelAP
2006-10-19Labeling · Supplement 29 · standardLetterAP
2005-06-29Labeling · Supplement 26 · standardLetterAP
2005-06-29Efficacy · Supplement 18 · standardReviewAP
2004-08-11Efficacy · Supplement 22 · standardLabelAP
2004-08-11Labeling · Supplement 25 · standardLabelAP
2003-12-16Labeling · Supplement 10 · standardLetterAP
2003-12-16Labeling · Supplement 19 · standardLetterAP
2003-12-16Efficacy · Supplement 17 · standardLabelAP
2003-06-12Labeling · Supplement 20 · standardLetterAP
2003-06-03Labeling · Supplement 15 · standardLetterAP
2003-04-15Labeling · Supplement 23 · standardLetterAP
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