Reduces salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and…. NDA 17558, held by Hikma. Glycopyrrolate.
As of Nov 13, 2026, NDA 17558 (Robinul), held by Hikma, was first approved by FDA on Feb 6, 1975, with 44 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.
| Jul 16, 2025 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Feb 6, 1975 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Robinul0.2MG/ML · injectable;injection | Glycopyrrolate | RxReference drug |
| Feb 24, 2026 | Supplement 66Labeling · Standard review | Approved | |
| Sep 25, 2025 | Supplement 69Manufacturing | Approved | |
| Jul 16, 2025 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Jul 12, 2024 | Supplement 63Manufacturing | Approved | |
| Jul 5, 2018 | Supplement 62Labeling · Standard review | Approved | |
| Mar 18, 2014 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| May 26, 2005 | Supplement 53Labeling · Standard review | Approved | |
| Nov 5, 2004 | Supplement 50Labeling · Standard review | Approved | |
| Nov 5, 2004 | Supplement 49Labeling · Standard review | Approved | |
| Nov 5, 2004 | Supplement 46Labeling · Standard review | Approved | |
| Nov 5, 2004 | Supplement 45Labeling · Standard review | Approved | |
| Jun 30, 2003 | Supplement 48Labeling · Standard review | Approved | |
| Jun 30, 2003 | Supplement 47Labeling · Standard review | Approved | |
| Apr 26, 2001 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1998 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1988 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1988 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1988 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1987 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1986 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1986 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1986 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1983 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1983 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1982 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1982 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1981 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1981 | Supplement 24Labeling | Approved | None posted |
| Oct 22, 1981 | Supplement 23Labeling | Approved | None posted |
| Oct 22, 1981 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1981 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1980 | Supplement 18Labeling | Approved | None posted |
| Sep 26, 1980 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1980 | Supplement 17Labeling | Approved | None posted |
| Apr 1, 1980 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1980 | Supplement 15Labeling | Approved | None posted |
| Apr 1, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1978 | Supplement 10Labeling | Approved | None posted |
| Aug 17, 1978 | Supplement 9Labeling | Approved | None posted |
| Apr 25, 1978 | Supplement 8Labeling | Approved | None posted |
| Nov 2, 1976 | Supplement 4Labeling | Approved | None posted |
| Sep 22, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1975 | Supplement 1Labeling | Approved | None posted |
| Feb 6, 1975 | Original applicationNew dosage form · Standard review | Approved |
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
