ANDA 220281, held by Adaptis. Oxcarbazepine.
As of Nov 15, 2026, ANDA 220281 (Oxcarbazepine), held by Adaptis, was first approved by FDA on Mar 9, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxcarbazepine300MG/5ML ยท suspension;oral | Oxcarbazepine | Discontinued |
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
