Glimepiride

ANDA 77274, held by Epic Pharma LLC. Glimepiride.

As of Nov 15, 2026, ANDA 77274 (Glimepiride), held by Epic Pharma LLC, was first approved by FDA on Oct 6, 2005, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2005
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

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

Products

3 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


May 31, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Apr 17, 2017	Supplement 8Labeling · Standard review	Approved	None posted
Nov 18, 2010	Supplement 7Labeling	Approved	None posted
Jun 23, 2010	Supplement 6Labeling	Approved	None posted
Sep 21, 2009	Supplement 5Labeling	Approved	None posted
Oct 1, 2007	Supplement 2Labeling	Approved	None posted
Aug 15, 2006	Supplement 1Labeling	Approved	None posted
Oct 6, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 77274
Drugs@FDA: Overview at FDA
Company: Epic 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