Glycopyrrolate

ANDA 40844, held by Sun Pharm Inds Ltd. Glycopyrrolate.

As of Nov 15, 2026, ANDA 40844 (Glycopyrrolate), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 18, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 18, 2009
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Aug 18, 2009	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


Jan 19, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Feb 13, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Aug 18, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 40844
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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