Reduces salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and…. ANDA 217354, held by Mankind Pharma. Glycopyrrolate.
As of Nov 15, 2026, ANDA 217354 (Glycopyrrolate), held by Mankind Pharma, was first approved by FDA on Feb 27, 2023, 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 |
|---|---|---|---|
| Feb 27, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate0.2MG/ML · injectable;injection | Glycopyrrolate | Discontinued |
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
