ANDA 74387, held by Ani Pharms. Glipizide.
As of Nov 15, 2026, ANDA 74387 (Glipizide), held by Ani Pharms, was first approved by FDA on Mar 4, 1996, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 1996 | Original application | Approved | None posted |
| Dec 20, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 21, 2000 | Supplement 3Labeling | Approved | None posted |
| Nov 19, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Mar 4, 1996 | 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
