ANDA 215902, held by Aurobindo Pharma. Safinamide Mesylate.
As of Nov 15, 2026, ANDA 215902 (Safinamide Mesylate), held by Aurobindo Pharma, was first approved by FDA on Jun 14, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2023 | Original application | Approved |
| Safinamide MesylateEQ 50MG BASE · tablet;oral | Safinamide Mesylate | Discontinued |
| Safinamide MesylateEQ 100MG BASE · tablet;oral | Safinamide Mesylate | 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
