ANDA 215664, held by Osmotica Pharm US. Carbamazepine.
As of Nov 15, 2026, ANDA 215664 (Carbamazepine), held by Osmotica Pharm US, was first approved by FDA on Oct 22, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2024 | Original application | Approved | None posted |
| Carbamazepine100MG · tablet, extended release;oral | Carbamazepine | Discontinued |
| Carbamazepine200MG · tablet, extended release;oral | Carbamazepine | Discontinued |
| Carbamazepine400MG · tablet, extended release;oral | Carbamazepine | 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
