ANDA 208405, held by Ph Health. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 208405 (Neostigmine Methylsulfate), held by Ph Health, was first approved by FDA on Apr 26, 2017, with 1 approved supplement and 0 published complete response letters.
Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non‑depolarizing neuromuscular blocking agents after surgery. Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2017 | 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 |
| May 31, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 26, 2017 | Original application | Approved | None posted |
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
