Glimepiride

For type 2 diabetes mellitus ]. ANDA 77911, held by Carlsbad. Glimepiride.

As of Nov 15, 2026, ANDA 77911 (Glimepiride), held by Carlsbad, was first approved by FDA on Sep 22, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 22, 2009
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Glimepiride Tablet, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ].

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
Sep 22, 2009	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 4Labeling · Standard review	Approved	None posted
May 31, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Sep 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77911
Drugs@FDA: Overview at FDA
Company: Carlsbad Technology

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