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FDA ANDA · ANDA076343

TOPIRAMATE

Sponsor: CIPLA LTD

APPLICATION
ANDA076343
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2023-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-09-08Labeling · Supplement 29 · standardAP
2023-03-08Labeling · Supplement 8 · standardAP
2023-03-08Labeling · Supplement 26 · standardAP
2023-03-08Labeling · Supplement 18 · standardAP
2023-03-08Labeling · Supplement 16 · standardAP
2023-03-08Labeling · Supplement 14 · standardAP
2023-03-08Labeling · Supplement 9 · standardAP
2023-03-08Labeling · Supplement 27 · standardAP
2023-03-08Labeling · Supplement 19 · standardAP
2023-03-08Labeling · Supplement 25 · standardAP
2023-03-08Labeling · Supplement 17 · standardAP
2023-03-08Labeling · Supplement 23 · standardAP
2014-11-19Labeling · Supplement 6 · standardAP
2010-01-27Labeling · Supplement 3AP
2009-09-30Labeling · Supplement 1AP
2009-03-27Original — Other Important Information from FDA ↗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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