Glimepiride

For type 2 diabetes mellitus. ANDA 202112, held by Regcon Holdings. Glimepiride.

As of Nov 15, 2026, ANDA 202112 (Glimepiride), held by Regcon Holdings, was first approved by FDA on Apr 17, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2013
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Apr 17, 2013	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 3 submissions, including labeling and manufacturing supplements


Oct 13, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Nov 26, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Apr 17, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202112
Drugs@FDA: Overview at FDA
Company: Regcon Holdings

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