ANDA 208112, held by Actavis LLC. Methylnaltrexone Bromide.
As of Nov 15, 2026, ANDA 208112 (Methylnaltrexone Bromide), held by Actavis LLC, was first approved by FDA on Aug 26, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2024 | Original application | Approved | None posted |
| Methylnaltrexone Bromide8MG/0.4ML (8MG/0.4ML) · solution;subcutaneous | Methylnaltrexone Bromide | Discontinued |
| Methylnaltrexone Bromide12MG/0.6ML (12MG/0.6ML) · 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
