Glipizide

For type 2 diabetes mellitus. ANDA 75795, held by Apotex. Glipizide.

As of Nov 15, 2026, ANDA 75795 (Glipizide), held by Apotex, was first approved by FDA on Jun 13, 2001, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2001
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Glipizide 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 6 submissions below

Date	Submission	Status	Documents
Jun 13, 2001	Original application	Approved	Letter

Products

2 strengths and forms


Glipizide5MG · tablet;oral	Glipizide	Rx
Glipizide10MG · tablet;oral	Glipizide	Rx

All 6 submissions, including labeling and manufacturing supplements


Apr 18, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Apr 26, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jul 26, 2013	Supplement 10Labeling · Standard review	Approved	None posted
Jul 26, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Mar 25, 2009	Supplement 8Labeling	Approved	None posted
Jun 13, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75795
Drugs@FDA: Overview at FDA
Company: Apotex

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