ANDA 218354, held by Long Grove Pharms. Edaravone.
As of Nov 15, 2026, ANDA 218354 (Edaravone), held by Long Grove Pharms, was first approved by FDA on May 6, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Edaravone30MG/100ML (0.3MG/ML) ยท solution;intravenous | Edaravone | 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
