For type 2 diabetes mellitus. ANDA 202327, held by Watson Labs Inc. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 202327 (Sitagliptin Phosphate), held by Watson Labs Inc, was first approved by FDA on Dec 29, 2025, 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 |
|---|---|---|---|
| Dec 29, 2025 | 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
