For type 2 diabetes mellitus. ANDA 202387, held by Sandoz. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 202387 (Sitagliptin Phosphate), held by Sandoz, was first approved by FDA on Jan 14, 2026, with 0 approved supplements and 0 published complete response letters.
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2026 | Original application | Approved |
| Sitagliptin PhosphateEQ 25MG BASE · tablet;oral | Sitagliptin Phosphate | Rx |
| Sitagliptin PhosphateEQ 50MG BASE · tablet;oral | Sitagliptin Phosphate | Rx |
| Sitagliptin PhosphateEQ 100MG BASE · tablet;oral | Sitagliptin Phosphate | Rx |
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
