Treats partial-onset seizures. ANDA 213183, held by Alkem Labs Ltd. Oxcarbazepine.
As of Nov 15, 2026, ANDA 213183 (Oxcarbazepine), held by Alkem Labs Ltd, was first approved by FDA on Mar 18, 2024, with 1 approved supplement and 0 published complete response letters.
Oxcarbazepine oral suspension 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. Oxcarbazepine oral suspension 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 children 2–16 years
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxcarbazepine300MG/5ML · suspension;oral | Oxcarbazepine | Rx |
| Feb 28, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 18, 2024 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
