Glycopyrrolate

Treats peptic ulcer. ANDA 203657, held by Alembic. Glycopyrrolate.

As of Nov 15, 2026, ANDA 203657 (Glycopyrrolate), held by Alembic, was first approved by FDA on Nov 30, 2018, with 1 approved supplement and 0 published complete response letters.

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

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 30, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 11, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Nov 30, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 203657
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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