ANDA 208230, held by Avet Lifesciences. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 208230 (Neostigmine Methylsulfate), held by Avet Lifesciences, was first approved by FDA on Nov 25, 2022, with 0 approved supplements and 0 published complete response letters.
Neostigmine methylsulfate injection USP, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. Neostigmine methylsulfate injection USP is a cholinesterase inhibitor indicated for the reversal of the effects of non depolarizing neuromuscular blocking agents after surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2022 | Original application | Approved | None posted |
| Neostigmine Methylsulfate5MG/10ML (0.5MG/ML) · solution;intravenous | Neostigmine Methylsulfate | Rx |
| Neostigmine Methylsulfate10MG/10ML (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
