Data updated: Mar 10, 2026
TOPAMAX SPRINKLE
TOPIRAMATE
Approved 1998-10-26
11
Indications
--
Phase 3 Trials
1
Priority Reviews
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-10-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TOPAMAX SPRINKLE Approval History
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What TOPAMAX SPRINKLE Treats
11 FDA approvalsOriginally approved for its first indication in 1998 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Oct 1998)Label Letter
- • Approved indication (Jul 1999)Label Letter
- • Approved indication (Oct 1999)
- • Approved indication (Aug 2001)Label Letter
- • Approved indication (Dec 2003)Label Letter
- • Approved indication (Aug 2004)Label Letter
- • Approved indication (Jun 2005)Label Letter
- • Approved indication (Dec 2009) PriorityLabel Letter
- • Approved indication (Jul 2011)Label Letter
- • Approved indication (Mar 2014)Label Letter
- • Approved indication (Jan 2022)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOPAMAX SPRINKLE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.