Data updated: Mar 10, 2026
EXTENDED PHENYTOIN SODIUM
PHENYTOIN SODIUM
Approved 1986-12-18
13
Indications
--
Phase 3 Trials
39
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-12-18
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
Lupin WOCKHARDT USA ANI PHARMS UNICHEM Sun Pharma TARO Viatris AMNEAL PHARMS NY MANKIND PHARMA WOCKHARDT Aurobindo Pharma
Active Ingredient: PHENYTOIN SODIUM
Website: ↗
EXTENDED PHENYTOIN SODIUM Approval History
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What EXTENDED PHENYTOIN SODIUM Treats
13 FDA approvalsOriginally approved for its first indication in 1986 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Dec 1986)
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Jun 2003)
- • Approved indication (Sep 2006)
- • Approved indication (Dec 2006)
- • Approved indication (Dec 2007)Label Letter
- • Approved indication (Jan 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Nov 2008)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Sep 2019)
- • Approved indication (Oct 2022)
- • Approved indication (Jan 2026) New
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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.
EXTENDED PHENYTOIN SODIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.