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Data updated: Mar 10, 2026

PHENYTOIN

PHENYTOIN Cytochrome P450 1A2 Inducers
Neurology Approved 1992-09-25
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Prescription
First Approved
1992-09-25
Routes
ORAL
Dosage Forms
TABLET, CHEWABLE, SUSPENSION

Companies

EPIC PHARMA LLC Teva RISING VISTAPHARM LLC PAI HOLDINGS PHARM TARO
Active Ingredient: PHENYTOIN

PHENYTOIN Approval History

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What PHENYTOIN Treats

3 indications

PHENYTOIN is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Generalized Tonic-Clonic Seizures
  • Complex Partial Seizures
  • Seizures
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PHENYTOIN FDA Label Details

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Indications & Usage

Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

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Data Sources

FDA Approval: ANDA040884 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.