Glyburide (Micronized)

For type 2 diabetes mellitus. ANDA 74686, held by Teva. Glyburide.

As of Nov 14, 2026, ANDA 74686 (Glyburide (Micronized)), held by Teva, was first approved by FDA on Apr 20, 1999, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 20, 1999
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Glyburide Tablets 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 16 submissions below

Date	Submission	Status	Documents
Apr 20, 1999	Original application	Approved	Review Letter

Products

4 strengths and forms


Glyburide (Micronized)1.5MG · tablet;oral	Glyburide	Rx
Glyburide (Micronized)3MG · tablet;oral	Glyburide	Rx
Glyburide (Micronized)4.5MG · tablet;oral	Glyburide	Rx
Glyburide (Micronized)6MG · tablet;oral	Glyburide	Rx

All 16 submissions, including labeling and manufacturing supplements


Oct 30, 2019	Supplement 28Labeling · Standard review	Approved	None posted
Sep 2, 2015	Supplement 27Labeling · Standard review	Approved	None posted
Mar 24, 2014	Supplement 25Labeling · Standard review	Approved	None posted
Aug 18, 2011	Supplement 20Labeling	Approved	None posted
Apr 28, 2010	Supplement 19Labeling	Approved	None posted
May 6, 2009	Supplement 18Labeling	Approved	None posted
May 6, 2009	Supplement 17Labeling	Approved	None posted
Oct 2, 2002	Supplement 10Manufacturing	Approved	None posted
Oct 2, 2002	Supplement 9Manufacturing	Approved	None posted
Oct 2, 2002	Supplement 8Manufacturing	Approved	None posted
Jul 1, 2002	Supplement 7Manufacturing	Approved	None posted
Sep 13, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 28, 2000	Supplement 4Manufacturing	Approved	None posted
Aug 28, 2000	Supplement 3Labeling	Approved	None posted
Feb 15, 2000	Supplement 5Labeling	Approved	None posted
Apr 20, 1999	Original application	Approved	Review Letter

Identifiers

Application: ANDA 74686
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