Glyburide

For type 2 diabetes mellitus. ANDA 90937, held by Heritage. Glyburide.

As of Nov 14, 2026, ANDA 90937 (Glyburide), held by Heritage, was first approved by FDA on Feb 28, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2011
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Glyburide tablets, USP is 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 6 submissions below

Date	Submission	Status	Documents
Feb 28, 2011	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 6 submissions, including labeling and manufacturing supplements


Jan 5, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 27, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Aug 25, 2011	Supplement 2Labeling	Approved	None posted
May 31, 2011	Supplement 1Labeling	Approved	None posted
Feb 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90937
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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