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FDA ANDA · ANDA077733

TOPIRAMATE

Sponsor: PHARMACO

APPLICATION
ANDA077733
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2014-11-18
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

2014-11-18Labeling · Supplement 5 · standardAP
2014-11-18Labeling · Supplement 1AP
2014-11-18Labeling · Supplement 4 · standardAP
2013-05-20REMS · Supplement 3AP
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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