ANDA 216291, held by Dr Reddys. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 216291 (Neostigmine Methylsulfate), held by Dr Reddys, was first approved by FDA on Jul 6, 2022, with 0 approved supplements and 0 published complete response letters.
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neostigmine Methylsulfate3MG/3ML (1MG/ML) · solution;intravenous | Neostigmine Methylsulfate | 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
