Glimepiride

ANDA 77295, held by Chartwell Molecular. Glimepiride.

As of Nov 15, 2026, ANDA 77295 (Glimepiride), held by Chartwell Molecular, was first approved by FDA on Oct 6, 2005, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2005
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 6, 2005	Original application	Approved	Letter

Products

3 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Apr 24, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Oct 25, 2010	Supplement 4Labeling	Approved	None posted
Jun 23, 2010	Supplement 3Labeling	Approved	None posted
Jun 11, 2009	Supplement 2Labeling	Approved	None posted
Dec 26, 2007	Supplement 1Labeling	Approved	None posted
Oct 6, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 77295
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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