ANDA 204947, held by Zydus Pharms. Lacosamide.
As of Nov 14, 2026, ANDA 204947 (Lacosamide), held by Zydus Pharms, was first approved by FDA on Dec 15, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2023 | Original application | Approved | None posted |
| Lacosamide50MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide100MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide150MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide200MG · tablet;oral | Lacosamide | 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
