Glipizide

ANDA 202298, held by Pharmobedient. Glipizide.

As of Nov 15, 2026, ANDA 202298 (Glipizide), held by Pharmobedient, was first approved by FDA on May 19, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: May 19, 2015
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
May 19, 2015	Original application	Approved	None posted

Products

3 strengths and forms


Glipizide2.5MG · tablet, extended release;oral	Glipizide	Discontinued
Glipizide5MG · tablet, extended release;oral	Glipizide	Discontinued
Glipizide10MG · tablet, extended release;oral	Glipizide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 11, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Apr 18, 2016	Supplement 3Labeling · Standard review	Approved	None posted
May 19, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202298
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