Glimepiride

ANDA 77624, held by Quagen. Glimepiride.

As of Nov 15, 2026, ANDA 77624 (Glimepiride), held by Quagen, was first approved by FDA on Nov 28, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 28, 2005
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 28, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Glimepiride1MG · tablet;oral	Glimepiride	Discontinued
Glimepiride2MG · tablet;oral	Glimepiride	Discontinued
Glimepiride4MG · tablet;oral	Glimepiride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 31, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Apr 17, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Apr 26, 2016	Supplement 5Labeling · Standard review	Approved	None posted
May 19, 2009	Supplement 3Labeling	Approved	None posted
Oct 1, 2007	Supplement 1Labeling	Approved	None posted
Nov 28, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77624
Drugs@FDA: Overview at FDA
Company: Quagen 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