Glycopyrrolate

ANDA 40821, held by Rising. Glycopyrrolate.

As of Nov 15, 2026, ANDA 40821 (Glycopyrrolate), held by Rising, was first approved by FDA on Dec 29, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 29, 2008
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
Dec 29, 2008	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 10, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Dec 29, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40821
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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