ANDA 220518, held by Eugia Pharma. Mesna.
As of Nov 13, 2026, ANDA 220518 (Mesna), held by Eugia Pharma, was first approved by FDA on Jan 27, 2026, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. Mesna injection is a cytoprotective agent
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesna100MG/ML · injectable;intravenous | Mesna | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
