Treats peptic ulcer. ANDA 210842, held by Piramal Critical. Glycopyrrolate.
As of Nov 15, 2026, ANDA 210842 (Glycopyrrolate), held by Piramal Critical, was first approved by FDA on Oct 25, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 25, 2018 | 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
