Glycopyrrolate

ANDA 40653, held by Ph Health. Glycopyrrolate.

As of Nov 15, 2026, ANDA 40653 (Glycopyrrolate), held by Ph Health, was first approved by FDA on Aug 31, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 2006
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
Aug 31, 2006	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


Feb 6, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Aug 31, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 40653
Drugs@FDA: Overview at FDA
Company: PH Health

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