Treats peptic ulcer. ANDA 212591, held by Nivagen. Glycopyrrolate.
As of Nov 15, 2026, ANDA 212591 (Glycopyrrolate), held by Nivagen, was first approved by FDA on Oct 13, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2021 | 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
