ANDA 204363, held by Eugia Pharma Speclts. Amifostine.
As of Nov 15, 2026, ANDA 204363 (Amifostine), held by Eugia Pharma Speclts, was first approved by FDA on Jul 17, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 17, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amifostine500MG/VIAL ยท injectable;injection | Amifostine | 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
