Reduces salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and…. NDA 214919, held by Fresenius Kabi USA. Glycopyrrolate.
As of Nov 13, 2026, NDA 214919 (Glycopyrrolate), held by Fresenius Kabi USA, was first approved by FDA on Apr 21, 2022, with 1 approved supplement and 0 published complete response letters.
Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in: anesthesia (all ages) for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate0.6MG/3ML (0.2MG/ML) · solution;intramuscular, intravenous | Glycopyrrolate | RxReference 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
