Glycopyrrolate

Treats peptic ulcer. ANDA 91182, held by Regcon Holdings. Glycopyrrolate.

As of Nov 15, 2026, ANDA 91182 (Glycopyrrolate), held by Regcon Holdings, was first approved by FDA on Feb 3, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 3, 2014
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Feb 3, 2014	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Sep 17, 2025	Supplement 8Labeling · Standard review	Approved	None posted
May 25, 2021	Supplement 6Manufacturing	Approved	None posted
Feb 23, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Feb 3, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91182
Drugs@FDA: Overview at FDA
Company: Regcon Holdings

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