ANDA 213074, held by Caplin. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 213074 (Neostigmine Methylsulfate), held by Caplin, was first approved by FDA on Apr 20, 2021, with 0 approved supplements 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2021 | 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
