ANDA 216542, held by Sagent Pharms Inc. Neostigmine Methylsulfate.
As of Nov 15, 2026, ANDA 216542 (Neostigmine Methylsulfate), held by Sagent Pharms Inc, was first approved by FDA on Feb 17, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2023 | 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
