Glipizide

For type 2 diabetes mellitus. ANDA 214874, held by Rubicon Research. Glipizide.

As of Nov 15, 2026, ANDA 214874 (Glipizide), held by Rubicon Research, was first approved by FDA on Oct 3, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 3, 2023
Review: Standard
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Oct 3, 2023	Original application	Approved	None posted

Products

4 strengths and forms


Glipizide2.5MG · tablet;oral	Glipizide	Rx
Glipizide5MG · tablet;oral	Glipizide	Rx
Glipizide10MG · tablet;oral	Glipizide	Rx
Glipizide15MG · tablet;oral	Glipizide	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 15, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Oct 3, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 214874
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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