ANDA 208038, held by US Generics, Steriles. Methylnaltrexone Bromide.
As of Nov 15, 2026, ANDA 208038 (Methylnaltrexone Bromide), held by US Generics, Steriles, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2021 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methylnaltrexone Bromide12MG/0.6ML ยท solution;subcutaneous | Methylnaltrexone Bromide | None (tentative approval) |
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
