Data updated: Mar 10, 2026
VALPROIC ACID
VALPROIC ACID
Approved 1986-02-28
15
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-02-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SYRUP
Companies
Sun Pharma SCHERER RP ANI PHARMS CHARTWELL RX PAI HOLDINGS LANNETT CO INC QUAGEN CATALENT BIONPHARMA PHARM ASSOC PAR PHARM Hikma HIBROW HLTHCARE PHARMOBEDIENT CNSLTG
Active Ingredient: VALPROIC ACID
Website: ↗
VALPROIC ACID Approval History
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What VALPROIC ACID Treats
15 FDA approvalsOriginally approved for its first indication in 1986 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Feb 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Jun 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Oct 1991)
- • Approved indication (Aug 1992)
- • Approved indication (Jun 1993)
- • Approved indication (Jan 1995)
- • Approved indication (Dec 2000)Letter
- • Approved indication (Dec 2000)Letter
- • Approved indication (Jul 2005)
- • Approved indication (Oct 2006)Letter
- • Approved indication (May 2010)
- • Approved indication (Feb 2013)
- • Approved indication (Aug 2019)
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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.
VALPROIC ACID FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.