ANDA 218871, held by Ingenus Pharms LLC. Mesna.
As of Nov 14, 2026, ANDA 218871 (Mesna), held by Ingenus Pharms LLC, was first approved by FDA on Jan 13, 2025, with 0 approved supplements and 0 published complete response letters.
Mesna is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesna400MG · tablet;oral | Mesna | 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
