APPLICATION
ANDA076575
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-17
LATEST ACTION
2024-01-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TOPIRAMATEDiscontinued
TOPIRAMATE 25MG · CAPSULE · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 15MG · CAPSULE · ORAL
Approval history
2024-01-09Labeling · Supplement 15 · standardAP
2024-01-09Labeling · Supplement 21 · standardAP
2024-01-09Labeling · Supplement 13 · standardAP
2024-01-09Labeling · Supplement 8 · standardAP
2024-01-09Labeling · Supplement 18 · standardAP
2024-01-09Labeling · Supplement 16 · standardAP
2024-01-09Labeling · Supplement 22 · standardAP
2024-01-09Labeling · Supplement 14 · standardAP
2024-01-09Labeling · Supplement 20 · standardAP
2024-01-09Labeling · Supplement 12 · standardAP
2024-01-09Labeling · Supplement 10 · standardAP
2024-01-09Labeling · Supplement 9 · standardAP
2014-11-18Labeling · Supplement 7 · standardAP
2014-11-18Labeling · Supplement 5 · standardAP
2014-11-18Labeling · Supplement 6 · standardAP
2014-11-18Labeling · Supplement 4 · standardAP
2011-07-14Labeling · Supplement 3AP
2010-10-30Labeling · Supplement 2AP
2009-09-30Labeling · Supplement 1AP
2009-04-17OriginalAP
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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