ANDA 219556, held by Epic Pharma LLC. Oxcarbazepine.
As of Nov 15, 2026, ANDA 219556 (Oxcarbazepine), held by Epic Pharma LLC, was first approved by FDA on Mar 2, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2026 | Original application | Approved | None posted |
| Oxcarbazepine150MG · tablet;oral | Oxcarbazepine | Rx |
| Oxcarbazepine300MG · tablet;oral | Oxcarbazepine | Rx |
| Oxcarbazepine600MG · tablet;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
