ANDA 208592, held by Mylan Labs Ltd. Methylnaltrexone Bromide.
As of Nov 15, 2026, ANDA 208592 (Methylnaltrexone Bromide), held by Mylan Labs Ltd, was first approved by FDA on May 28, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methylnaltrexone Bromide12MG/0.6ML (12MG/0.6ML) ยท solution;subcutaneous | Methylnaltrexone Bromide | 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
