Glycopyrrolate

Treats peptic ulcer. ANDA 89335, held by Am Regent. Glycopyrrolate.

As of Nov 15, 2026, ANDA 89335 (Glycopyrrolate), held by Am Regent, was first approved by FDA on Jul 23, 1986, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 23, 1986
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE In Anesthesia: Glycopyrrolate injection 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 may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jul 23, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Glycopyrrolate0.2MG/ML · injectable;injection	Glycopyrrolate	Rx

All 12 submissions, including labeling and manufacturing supplements


Sep 4, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Sep 26, 2006	Supplement 15Labeling	Approved	None posted
Jun 23, 1997	Supplement 10Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 9Manufacturing	Approved	None posted
May 9, 1991	Supplement 3Manufacturing	Approved	None posted
May 9, 1991	Supplement 4Manufacturing	Approved	None posted
May 9, 1991	Supplement 8Manufacturing	Approved	None posted
Mar 4, 1991	Supplement 5Manufacturing	Approved	None posted
Mar 15, 1990	Supplement 7Labeling	Approved	None posted
Jan 25, 1990	Supplement 6Labeling	Approved	None posted
Sep 8, 1988	Supplement 2Labeling	Approved	None posted
Jul 23, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89335
Drugs@FDA: Overview at FDA
Company: Am Regent

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