ANDA 205239, held by Eugia Pharma Speclts. Dantrolene Sodium.
As of Nov 15, 2026, ANDA 205239 (Dantrolene Sodium), held by Eugia Pharma Speclts, was first approved by FDA on Feb 18, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dantrolene Sodium20MG/VIAL ยท injectable;injection | Dantrolene Sodium | 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
