For type 2 diabetes mellitus. ANDA 74497, held by Ani Pharms. Glipizide.
As of Nov 15, 2026, ANDA 74497 (Glipizide), held by Ani Pharms, was first approved by FDA on Aug 31, 1995, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 1995 | Original application | Approved | None posted |
| Dec 20, 2019 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 20, 2019 | Supplement 29Labeling · Standard review | Approved | None posted |
| May 25, 2011 | Supplement 25Labeling | Approved | None posted |
| Jan 27, 2010 | Supplement 20Labeling | Approved | None posted |
| Mar 11, 2009 | Supplement 18Labeling | Approved | None posted |
| Apr 25, 2008 | Supplement 15Labeling | Approved | None posted |
| Jul 29, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 6Manufacturing | Approved | None posted |
| Sep 12, 2001 | Supplement 5Manufacturing | Approved | None posted |
| May 31, 2000 | Supplement 3Manufacturing | Approved | None posted |
| May 31, 2000 | Supplement 4Labeling | Approved | None posted |
| Jan 28, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Oct 20, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Aug 31, 1995 | Original application | Approved | None posted |
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
