Glucovance

NDA 21178, held by Bristol Myers Squibb. Glyburide; Metformin Hydrochloride.

As of Nov 14, 2026, NDA 21178 (Glucovance), held by Bristol Myers Squibb, was first approved by FDA on Jul 31, 2000, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2000
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Mar 15, 2004	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Statistical Review
Sep 30, 2002	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 31, 2000	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Glucovance1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glyburide; Metformin Hydrochloride	DiscontinuedReference drug
Glucovance2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glyburide; Metformin Hydrochloride	DiscontinuedReference drug
Glucovance5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glyburide; Metformin Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Dec 27, 2018	Supplement 18Labeling · Standard review	Approved	Label Letter
Apr 5, 2017	Supplement 17Labeling	Approved	Letter Label
Apr 5, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 15, 2013	Supplement 15Labeling · Standard review	Approved	Label Letter
Aug 15, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 14, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 24, 2010	Supplement 12Labeling	Approved	Label Letter
Nov 24, 2009	Supplement 11Labeling · Standard review	Approved	Label
Sep 16, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 14, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 15, 2004	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Statistical Review
Sep 30, 2002	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 8, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 2, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 28, 2001	Supplement 2Labeling · Standard review	Approved	None posted
Dec 13, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 31, 2000	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21178
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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