Glycopyrrolate

ANDA 81169, held by Teva Parenteral. Glycopyrrolate.

As of Nov 15, 2026, ANDA 81169 (Glycopyrrolate), held by Teva Parenteral, was first approved by FDA on Sep 10, 1991, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 10, 1991
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
Sep 10, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jun 2, 1995	Supplement 2Manufacturing	Approved	None posted
Dec 29, 1993	Supplement 1Manufacturing	Approved	None posted
Sep 10, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81169
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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