For type 2 diabetes mellitus. ANDA 219159, held by Graviti Pharms. Glipizide.
As of Nov 15, 2026, ANDA 219159 (Glipizide), held by Graviti Pharms, was first approved by FDA on Mar 4, 2026, with 0 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 |
|---|---|---|---|
| Mar 4, 2026 | 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
