NDA 203629, held by Fresenius Kabi USA. Neostigmine Methylsulfate.
As of Nov 14, 2026, NDA 203629 (Neostigmine Methylsulfate), held by Fresenius Kabi USA, was first approved by FDA on Jan 8, 2015, with 2 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 |
|---|---|---|---|
| Jan 8, 2015 | Original applicationNew dosage form · Standard review | Approved |
| Neostigmine Methylsulfate5MG/10ML (0.5MG/ML) · solution;intravenous | Neostigmine Methylsulfate | RxReference drug |
| Neostigmine Methylsulfate10MG/10ML (1MG/ML) · solution;intravenous | Neostigmine Methylsulfate | RxReference drug |
| Neostigmine Methylsulfate3MG/3ML (1MG/ML) · solution;intravenous | Neostigmine Methylsulfate | RxReference drug |
| Feb 4, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Jul 31, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 8, 2015 | Original applicationNew dosage form · Standard review | Approved |
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
