Treats partial-onset seizures. ANDA 218278, held by Biocon Pharma. Oxcarbazepine.
As of Nov 15, 2026, ANDA 218278 (Oxcarbazepine), held by Biocon Pharma, was first approved by FDA on Mar 1, 2024, with 2 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 |
|---|---|---|---|
| Mar 1, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxcarbazepine300MG/5ML · suspension;oral | Oxcarbazepine | Rx |
| Oct 8, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 28, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 1, 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
