Glyburide

For type 2 diabetes mellitus. ANDA 74388, held by Teva. Glyburide.

As of Nov 14, 2026, ANDA 74388 (Glyburide), held by Teva, was first approved by FDA on Aug 29, 1995, with 24 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1995
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Glyburide tablets USP are 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 25 submissions below

Date	Submission	Status	Documents
Aug 29, 1995	Original application	Approved	None posted

Products

3 strengths and forms


Glyburide1.25MG · tablet;oral	Glyburide	Rx
Glyburide2.5MG · tablet;oral	Glyburide	Rx
Glyburide5MG · tablet;oral	Glyburide	Rx

All 25 submissions, including labeling and manufacturing supplements


Sep 3, 2015	Supplement 46Labeling · Standard review	Approved	None posted
Jan 16, 2015	Supplement 43Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 35Manufacturing	Approved	None posted
Jan 23, 2014	Supplement 41Labeling · Standard review	Approved	None posted
Jan 23, 2014	Supplement 30Labeling	Approved	None posted
Sep 11, 2012	Supplement 31Labeling	Approved	None posted
Sep 23, 2010	Supplement 37Labeling	Approved	None posted
Jun 23, 2010	Supplement 36Labeling	Approved	None posted
May 1, 2009	Supplement 32Labeling	Approved	None posted
Jan 15, 2009	Supplement 29Labeling	Approved	None posted
Feb 26, 2002	Supplement 17Manufacturing	Approved	None posted
Jul 18, 2001	Supplement 16Manufacturing	Approved	None posted
Jun 26, 2000	Supplement 14Manufacturing	Approved	None posted
Jun 26, 2000	Supplement 13Manufacturing	Approved	None posted
Jan 20, 2000	Supplement 15Labeling	Approved	None posted
Mar 23, 1999	Supplement 9Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 8Manufacturing	Approved	None posted
Jun 8, 1998	Supplement 6Manufacturing	Approved	None posted
Apr 2, 1998	Supplement 7Labeling	Approved	None posted
Apr 2, 1998	Supplement 5Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 1Manufacturing	Approved	None posted
Feb 2, 1998	Supplement 3Manufacturing	Approved	None posted
Oct 15, 1997	Supplement 4Labeling	Approved	None posted
Aug 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74388
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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