Glucotrol Xl

For type 2 diabetes mellitus. NDA 20329, held by Pfizer. Glipizide.

As of Nov 13, 2026, NDA 20329 (Glucotrol Xl), held by Pfizer, was first approved by FDA on Apr 26, 1994, with 22 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1994
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GLUCOTROL XL 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 23 submissions below


Apr 1, 2002	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 4, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 26, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Glucotrol Xl5MG · tablet, extended release;oral	Glipizide	RxReference drug
Glucotrol Xl10MG · tablet, extended release;oral	Glipizide	RxReference drug
Glucotrol Xl2.5MG · tablet, extended release;oral	Glipizide	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Aug 3, 2021	Supplement 35Manufacturing	Approved	Letter Label
Aug 10, 2018	Supplement 32Labeling · Standard review	Approved	Letter Label
Aug 16, 2017	Supplement 30Labeling · Standard review	Approved	Letter Label
Oct 5, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Oct 15, 2013	Supplement 28Labeling · Standard review	Approved	Label Letter
Feb 7, 2011	Supplement 25Labeling	Approved	Letter Label
Aug 31, 2009	Supplement 24Labeling · Standard review	Approved	Label
Oct 27, 2008	Supplement 22Labeling · Standard review	Approved	Label Letter
Sep 17, 2003	Supplement 15Labeling · Standard review	Approved	Review Letter
Apr 1, 2002	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 26, 2001	Supplement 13Labeling · Standard review	Approved	None posted
Sep 5, 2001	Supplement 6Labeling · Standard review	Approved	None posted
Jun 25, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 16, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 31, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 26, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 26, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 17, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 15, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 18, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 10, 1999	Supplement 3Manufacturing · Standard review	Approved	Review
Feb 4, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 26, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20329
Drugs@FDA: Overview at FDA
Company: Pfizer

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