ANDA 212512, held by Be Pharms. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 212512 (Neostigmine Methylsulfate), held by Be Pharms, was first approved by FDA on May 13, 2019, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2019 | 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 10, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 13, 2019 | 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
