Treats partial-onset seizures. ANDA 209020, held by Msn. Oxcarbazepine.
As of Nov 15, 2026, ANDA 209020 (Oxcarbazepine), held by Msn, was first approved by FDA on May 29, 2026, with 0 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:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxcarbazepine300MG/5ML · suspension;oral | Oxcarbazepine | Rx |
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
