NDA 216903, held by Azurity. Glycopyrrolate; Neostigmine Methylsulfate.
As of Nov 14, 2026, NDA 216903 (Prevduo), held by Azurity, was first approved by FDA on Feb 23, 2023, with 0 approved supplements and 0 published complete response letters.
PREVDUO, a fixed dose combination of cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2023 | Original applicationTYPE 4/5 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prevduo0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) · solution;intravenous | Glycopyrrolate; Neostigmine Methylsulfate | DiscontinuedReference drug |
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
