Glimepiride

For type 2 diabetes mellitus. ANDA 202759, held by Aurobindo Pharma Ltd. Glimepiride.

As of Nov 15, 2026, ANDA 202759 (Glimepiride), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 29, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 29, 2012	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


May 31, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Dec 27, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jun 29, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202759
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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