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FDA ANDA · ANDA079153

TOPIRAMATE

Sponsor: TORRENT PHARMS

APPLICATION
ANDA079153
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2019-01-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOPIRAMATEDiscontinued
TOPIRAMATE 25MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 200MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 50MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 100MG · TABLET · ORAL

Approval history

2019-01-24Labeling · Supplement 20 · standardAP
2019-01-24Labeling · Supplement 21 · standardAP
2015-11-30Labeling · Supplement 17 · standardAP
2014-12-01Labeling · Supplement 12AP
2014-12-01Labeling · Supplement 16 · standardAP
2013-04-29Labeling · Supplement 14 · standardAP
2011-07-14Labeling · Supplement 8AP
2010-08-11Labeling · Supplement 6AP
2010-01-22Labeling · Supplement 2AP
2010-01-22Labeling · Supplement 3AP
2010-01-21Manufacturing (CMC) · Supplement 4AP
2009-03-27Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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