OXCARBAZEPINE
Details
- Status
- Prescription
- First Approved
- 2007-10-09
- Routes
- ORAL, EXTENDED RELEASE
- Dosage Forms
- TABLET, SUSPENSION, TABLET, EXTENDED RELEASE
Companies
OXCARBAZEPINE Approval History
What OXCARBAZEPINE Treats
26 FDA approvalsOriginally approved for its first indication in 2007 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Oct 2007)Label Letter
- • Approved indication (Nov 2007)
- • Approved indication (Dec 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Apr 2008)
- • Approved indication (Jun 2009)Letter
- • Approved indication (Jan 2010)
- • Approved indication (Sep 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Jun 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Jul 2023)
- • Approved indication (Jul 2023)Letter
- • Approved indication (Oct 2023)
- • Approved indication (Feb 2024)
- • Approved indication (Feb 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) New
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
OXCARBAZEPINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Oxcarbazepine tablets are 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. Oxcarbazepine tablets are 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 to 16 years - Adjunctive therapy in the treat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.