Treats partial-onset seizures. ANDA 204921, held by Msn Labs Pvt Ltd. Lacosamide.
As of Nov 14, 2026, ANDA 204921 (Lacosamide), held by Msn Labs Pvt Ltd, was first approved by FDA on Mar 17, 2022, with 1 approved supplement and 0 published complete response letters.
Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2022 | Original application | Approved |
| Lacosamide50MG · tablet;oral | Lacosamide | Rx |
| Lacosamide100MG · tablet;oral | Lacosamide | Rx |
| Lacosamide150MG · tablet;oral | Lacosamide | Rx |
| Lacosamide200MG · tablet;oral | Lacosamide | Rx |
| Jul 29, 2026 | Supplement 8Manufacturing | Approved | None posted |
| Mar 17, 2022 | Original application | Approved |
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
