Glipizide

For type 2 diabetes mellitus. ANDA 74378, held by Oxford Pharms. Glipizide.

As of Nov 15, 2026, ANDA 74378 (Glipizide), held by Oxford Pharms, was first approved by FDA on Nov 28, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 28, 1994
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Nov 28, 1994	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 1, 1999	Supplement 4Manufacturing	Approved	None posted
Apr 30, 1996	Supplement 3Labeling	Approved	None posted
Jul 7, 1995	Supplement 1Manufacturing	Approved	None posted
Jul 7, 1995	Supplement 2Labeling	Approved	None posted
Nov 28, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74378
Drugs@FDA: Overview at FDA
Company: Oxford 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