Data updated: Mar 10, 2026
PRIMIDONE
PRIMIDONE
Approved 1978-12-01
10
Indications
--
Phase 3 Trials
47
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1978-12-01
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
WATSON LABS RUBICON RESEARCH OXFORD PHARMS IMPAX LABS CARNEGIE CHARTWELL RX LANNETT Hikma AMNEAL PHARM TP ANDA HOLDINGS
Active Ingredient: PRIMIDONE
Website: ↗
PRIMIDONE Approval History
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What PRIMIDONE Treats
10 FDA approvalsOriginally approved for its first indication in 1978 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Dec 1978)
- • Approved indication (Feb 1979)
- • Approved indication (Feb 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Jul 2006)
- • Approved indication (Feb 2008)
- • Approved indication (Apr 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Jun 2022)
- • Approved indication (Jan 2024)
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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.
PRIMIDONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.