ANDA 204839, held by Amneal Pharms. Lacosamide.
As of Nov 14, 2026, ANDA 204839 (Lacosamide), held by Amneal Pharms, was first approved by FDA on Mar 27, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML ยท solution;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
