Glimepiride

ANDA 77280, held by Watson Labs. Glimepiride.

As of Nov 15, 2026, ANDA 77280 (Glimepiride), held by Watson Labs, was first approved by FDA on Feb 3, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 3, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 3, 2006	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jan 19, 2010	Supplement 4Labeling	Approved	None posted
Jun 29, 2008	Supplement 2Labeling	Approved	None posted
Feb 3, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77280
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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