Treats partial-onset seizures. ANDA 207717, held by Rubicon Research. Oxcarbazepine.
As of Nov 15, 2026, ANDA 207717 (Oxcarbazepine), held by Rubicon Research, was first approved by FDA on Mar 5, 2024, with 1 approved supplement and 0 published complete response letters.
Oxcarbazepine tablets 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 tablets 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 5, 2024 | Original application | Approved | None posted |
| Oxcarbazepine150MG · tablet;oral | Oxcarbazepine | Rx |
| Oxcarbazepine300MG · tablet;oral | Oxcarbazepine | Rx |
| Oxcarbazepine600MG · tablet;oral | Oxcarbazepine | Rx |
| May 15, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 5, 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
