APPLICATION
ANDA090278
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2023-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
TOPIRAMATEDiscontinued
TOPIRAMATE 200MG · TABLET · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 50MG · TABLET · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 100MG · TABLET · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 25MG · TABLET · ORAL
Approval history
2023-10-10Labeling · Supplement 31 · standardAP
2023-03-08Labeling · Supplement 19 · standardAP
2023-03-08Labeling · Supplement 17 · standardAP
2023-03-08Labeling · Supplement 23 · standardAP
2023-03-08Labeling · Supplement 28 · standardAP
2023-03-08Labeling · Supplement 26 · standardAP
2023-03-08Labeling · Supplement 30 · standardAP
2023-03-08Labeling · Supplement 14 · standardAP
2023-03-08Labeling · Supplement 20 · standardAP
2015-10-30Labeling · Supplement 13 · standardAP
2015-10-30Labeling · Supplement 11 · standardAP
2015-10-30Labeling · Supplement 10 · standardAP
2014-12-01Labeling · Supplement 6 · standardAP
2014-12-01Labeling · Supplement 9 · standardAP
2014-12-01Labeling · Supplement 7 · standardAP
2010-01-27Labeling · Supplement 4AP
2010-01-27REMS · Supplement 3AP
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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