Reduces salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and…. ANDA 215333, held by Amneal. Glycopyrrolate.
As of Nov 15, 2026, ANDA 215333 (Glycopyrrolate), held by Amneal, was first approved by FDA on Oct 21, 2022, with 0 approved supplements and 0 published complete response letters.
Glycopyrrolate injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) 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. for protection against peripheral muscarinic effects of cholinergic agents. in peptic ulcer (adults) To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate0.2MG/ML · injectable;injection | Glycopyrrolate | 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
