ANDA 218447, held by Adaptis. Carbamazepine.
As of Nov 15, 2026, ANDA 218447 (Carbamazepine), held by Adaptis, was first approved by FDA on Nov 2, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2026 | Original application | Approved | None posted |
| Carbamazepine100MG · tablet, extended release;oral | Carbamazepine | Rx |
| Carbamazepine200MG · tablet, extended release;oral | Carbamazepine | Rx |
| Carbamazepine400MG · tablet, extended release;oral | Carbamazepine | 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
