Glimepiride

ANDA 76802, held by Pharmazone. Glimepiride.

As of Nov 15, 2026, ANDA 76802 (Glimepiride), held by Pharmazone, was first approved by FDA on Oct 6, 2005, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2005
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

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

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


May 31, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Apr 17, 2017	Supplement 18Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Jul 31, 2013	Supplement 15Labeling	Approved	None posted
Mar 23, 2012	Supplement 11Labeling	Approved	None posted
Nov 30, 2009	Supplement 12Labeling	Approved	None posted
Nov 30, 2009	Supplement 13Labeling	Approved	None posted
Nov 30, 2009	Supplement 14Labeling	Approved	None posted
Dec 26, 2007	Supplement 6Labeling	Approved	None posted
Dec 19, 2006	Supplement 4Labeling	Approved	None posted
Oct 6, 2005	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76802
Drugs@FDA: Overview at FDA
Company: Pharmazone

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