For type 2 diabetes mellitus. ANDA 202425, held by Apotex. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 202425 (Sitagliptin Phosphate), held by Apotex, was first approved by FDA on Jan 20, 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 has 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 20, 2026 | Original application | Approved | None posted |
| 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
