Glycopyrrolate

ANDA 40836, held by Hikma. Glycopyrrolate.

As of Nov 15, 2026, ANDA 40836 (Glycopyrrolate), held by Hikma, was first approved by FDA on Mar 5, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 5, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 5, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Glycopyrrolate1MG · tablet;oral	Glycopyrrolate	Discontinued
Glycopyrrolate2MG · tablet;oral	Glycopyrrolate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 23, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Mar 5, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 40836
Drugs@FDA: Overview at FDA
Company: Hikma

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