Glimepiride

For type 2 diabetes mellitus. ANDA 77370, held by Prinston. Glimepiride.

As of Nov 15, 2026, ANDA 77370 (Glimepiride), held by Prinston, was first approved by FDA on Dec 23, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2005
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Glimepiride tablets USP 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 USP 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 6 submissions below

Date	Submission	Status	Documents
Dec 23, 2005	Original application	Approved	None posted

Products

4 strengths and forms


Glimepiride1MG · tablet;oral	Glimepiride	Rx
Glimepiride2MG · tablet;oral	Glimepiride	Rx
Glimepiride4MG · tablet;oral	Glimepiride	Rx
Glimepiride8MG · tablet;oral	Glimepiride	Rx

All 6 submissions, including labeling and manufacturing supplements


May 6, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Oct 27, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Oct 27, 2015	Supplement 10Labeling · Standard review	Approved	None posted
May 31, 2012	Supplement 4Labeling	Approved	None posted
Apr 28, 2008	Supplement 2Labeling	Approved	None posted
Dec 23, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77370
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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