ANDA 204980, held by Glenmark Pharms Ltd. Lacosamide.
As of Nov 14, 2026, ANDA 204980 (Lacosamide), held by Glenmark Pharms Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2016 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML ยท solution;oral | Lacosamide | None (tentative approval) |
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
