APPLICATION
ANDA076311
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2014-09-24
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
2014-09-24Labeling · Supplement 3AP
2011-06-14REMS · Supplement 2AP
2010-01-28Labeling · Supplement 1AP
2009-03-27OriginalAP
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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