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FDA ANDA · ANDA090162

TOPIRAMATE

Sponsor: UNICHEM LABS LTD

APPLICATION
ANDA090162
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2023-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-09-22Labeling · Supplement 31 · standardAP
2023-03-08Labeling · Supplement 27 · standardAP
2023-03-08Labeling · Supplement 25 · standardAP
2023-03-08Labeling · Supplement 15 · standardAP
2023-03-08Labeling · Supplement 7 · standardAP
2023-03-08Labeling · Supplement 18 · standardAP
2023-03-08Labeling · Supplement 30 · standardAP
2023-03-08Labeling · Supplement 8 · standardAP
2023-03-08Labeling · Supplement 14 · standardAP
2023-03-08Labeling · Supplement 20 · standardAP
2023-03-08Labeling · Supplement 10 · standardAP
2014-12-01Labeling · Supplement 5 · standardAP
2013-02-19Manufacturing (CMC) · Supplement 2AP
2010-12-28Labeling · Supplement 1AP
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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