ANDA 215978, held by Msn. Safinamide Mesylate.
As of Nov 15, 2026, ANDA 215978 (Safinamide Mesylate), held by Msn, was first approved by FDA on Dec 31, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2024 | Original application | Approved | None posted |
| Safinamide MesylateEQ 50MG BASE · tablet;oral | Safinamide Mesylate | Rx |
| Safinamide MesylateEQ 100MG BASE · tablet;oral | Safinamide Mesylate | 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
