ANDA 210652, held by Regcon Holdings. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 210652 (Neostigmine Methylsulfate), held by Regcon Holdings, was first approved by FDA on Oct 1, 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 |
|---|---|---|---|
| Oct 1, 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
