Glycopyrrolate

ANDA 89393, held by Hospira. Glycopyrrolate.

As of Nov 15, 2026, ANDA 89393 (Glycopyrrolate), held by Hospira, was first approved by FDA on Jun 15, 1988, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1988
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 15, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Glycopyrrolate0.2MG/ML · injectable;injection	Glycopyrrolate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


May 5, 1998	Supplement 6Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 4Manufacturing	Approved	None posted
May 20, 1991	Supplement 1Labeling	Approved	None posted
Jun 15, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89393
Drugs@FDA: Overview at FDA
Company: Hospira

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