Treats peptic ulcer. ANDA 90963, held by Hikma Farmaceutica. Glycopyrrolate.
As of Nov 15, 2026, ANDA 90963 (Glycopyrrolate), held by Hikma Farmaceutica, was first approved by FDA on Sep 21, 2011, with 1 approved supplement 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 |
|---|---|---|---|
| Sep 21, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate0.2MG/ML · injectable;injection | Glycopyrrolate | Rx |
| Aug 31, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 21, 2011 | Original application | Approved | None posted |
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
