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Data updated: Mar 10, 2026

TRILEPTAL

OXCARBAZEPINE
Neurology Approved 2000-01-14
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
26
Years on Market

Details

Status
Prescription
First Approved
2000-01-14
Routes
ORAL
Dosage Forms
TABLET, SUSPENSION

Companies

Novartis
Active Ingredient: OXCARBAZEPINE

TRILEPTAL Approval History

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What TRILEPTAL Treats

1 indications

TRILEPTAL is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Partial-Onset Seizures
Source: FDA Label

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Key Completed Trials

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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.

TRILEPTAL FDA Label Details

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Indications & Usage

FDA Label (PDF)

TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in...

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Data Sources

FDA Approval: NDA021014 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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