Glipizide

ANDA 74438, held by Pharmobedient. Glipizide.

As of Nov 15, 2026, ANDA 74438 (Glipizide), held by Pharmobedient, was first approved by FDA on Jun 20, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 20, 1995
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 20, 1995	Original application	Approved	None posted

Products

2 strengths and forms


Glipizide5MG · tablet;oral	Glipizide	Discontinued
Glipizide10MG · tablet;oral	Glipizide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


May 19, 2009	Supplement 4Labeling	Approved	None posted
Sep 27, 2001	Supplement 2Labeling	Approved	None posted
Nov 1, 2000	Supplement 1Labeling	Approved	None posted
Jun 20, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74438
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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