Glycopyrrolate

Treats peptic ulcer. ANDA 202675, held by Aurobindo Pharma. Glycopyrrolate.

As of Nov 15, 2026, ANDA 202675 (Glycopyrrolate), held by Aurobindo Pharma, was first approved by FDA on Oct 30, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 30, 2018
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Oct 30, 2018	Original application	Approved	None posted
Apr 15, 2013	Original application	Approved	None posted

Products

2 strengths and forms


Glycopyrrolate1MG · tablet;oral	Glycopyrrolate	Rx
Glycopyrrolate2MG · tablet;oral	Glycopyrrolate	Rx

All 3 submissions, including labeling and manufacturing supplements


Apr 18, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Oct 30, 2018	Original application	Approved	None posted
Apr 15, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202675
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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