APPLICATION
ANDA078235
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2024-10-23
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
2024-10-23Labeling · Supplement 35 · standardAP
2023-09-08Labeling · Supplement 34 · standardAP
2023-05-25Labeling · Supplement 33 · standardAP
2023-05-25Labeling · Supplement 32 · standardAP
2022-01-07Labeling · Supplement 31 · standardAP
2020-10-01Labeling · Supplement 25 · standardAP
2020-10-01Labeling · Supplement 23 · standardAP
2020-10-01Labeling · Supplement 21 · standardAP
2020-10-01Labeling · Supplement 24 · standardAP
2020-10-01Labeling · Supplement 20 · standardAP
2020-10-01Labeling · Supplement 29 · standardAP
2015-10-30Labeling · Supplement 15 · standardAP
2015-10-30Labeling · Supplement 18 · standardAP
2015-10-30Labeling · Supplement 16 · standardAP
2014-11-18Labeling · Supplement 8AP
2014-11-18Labeling · Supplement 14 · standardAP
2014-11-18Labeling · Supplement 12 · standardAP
2014-11-18Labeling · Supplement 10 · standardAP
2011-06-24Labeling · Supplement 7AP
2011-06-24Labeling · Supplement 6AP
2010-08-13Labeling · Supplement 4AP
2010-01-13Labeling · Supplement 1AP
2010-01-13REMS · Supplement 2AP
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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