Treats partial-onset seizures. ANDA 212428, held by Chartwell Rx. Oxcarbazepine.
As of Nov 15, 2026, ANDA 212428 (Oxcarbazepine), held by Chartwell Rx, was first approved by FDA on Jun 21, 2021, with 3 approved supplements 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 to 16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxcarbazepine300MG/5ML · suspension;oral | Oxcarbazepine | Rx |
| May 12, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 8, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 8, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 21, 2021 | 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
