For type 2 diabetes mellitus. ANDA 74223, held by Watson Labs Teva. Glipizide.
As of Nov 15, 2026, ANDA 74223 (Glipizide), held by Watson Labs Teva, was first approved by FDA on Feb 27, 1995, with 12 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 1995 | Original application | Approved | None posted |
| Mar 30, 2026 | Supplement 27Manufacturing | Approved | None posted |
| May 16, 2021 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jan 5, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 26, 2013 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jun 17, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Jun 13, 2002 | Supplement 8Manufacturing | Approved | None posted |
| Sep 25, 2001 | Supplement 6Labeling | Approved | None posted |
| Sep 5, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Jul 13, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Jan 20, 2000 | Supplement 4Labeling | Approved | None posted |
| Nov 10, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Nov 5, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Feb 27, 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
