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Data updated: Mar 10, 2026

PHENYTEK

PHENYTOIN SODIUM
Neurology Approved 1998-12-28
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
27
Years on Market

Details

Status
Prescription
First Approved
1998-12-28
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Viatris
Active Ingredient: PHENYTOIN SODIUM

PHENYTEK Approval History

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What PHENYTEK Treats

3 indications

PHENYTEK is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tonic-Clonic Seizures
  • Psychomotor Seizures
  • Seizures
Source: FDA Label

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Trial Timeline

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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.

PHENYTEK FDA Label Details

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Indications & Usage

FDA Label (PDF)

PHENYTEK ® capsules (extended phenytoin sodium capsules) are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. PHENYTEK ® CAPSULES are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

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Data Sources

FDA Approval: ANDA040298 → Label: DailyMed → Trials: ClinicalTrials.gov →

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