For type 2 diabetes mellitus. ANDA 74305, held by Aiping Pharm Inc. Glipizide.
As of Nov 15, 2026, ANDA 74305 (Glipizide), held by Aiping Pharm Inc, was first approved by FDA on Apr 7, 1995, with 16 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 |
|---|---|---|---|
| Apr 7, 1995 | Original application | Approved | None posted |
| Sep 23, 2026 | Supplement 33Manufacturing | Approved | None posted |
| Apr 11, 2017 | Supplement 30Labeling · Standard review | Approved | None posted |
| Apr 11, 2017 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jul 26, 2013 | Supplement 24Labeling | Approved | None posted |
| May 19, 2009 | Supplement 23Labeling | Approved | None posted |
| Apr 19, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Mar 25, 2002 | Supplement 12Manufacturing | Approved | None posted |
| Dec 5, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Sep 21, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Aug 9, 2001 | Supplement 10Labeling | Approved | None posted |
| Dec 13, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Nov 30, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Dec 17, 1999 | Supplement 5Labeling | Approved | None posted |
| Feb 1, 1999 | Supplement 3Labeling | Approved | None posted |
| Feb 1, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Oct 22, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Apr 7, 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
