ANDA 218349, held by Zydus Pharms. Edaravone.
As of Nov 15, 2026, ANDA 218349 (Edaravone), held by Zydus Pharms, was first approved by FDA on Jul 22, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Edaravone30MG/100ML (0.3MG/ML) ยท solution;intravenous | Edaravone | 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
