ANDA 216206, held by Hikma. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 216206 (Neostigmine Methylsulfate), held by Hikma, was first approved by FDA on Jul 13, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neostigmine Methylsulfate3MG/3ML (1MG/ML) ยท solution;intravenous | Neostigmine Methylsulfate | 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
