ANDA 215155, held by Alkem Labs Ltd. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 215155 (Sitagliptin Phosphate), held by Alkem Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2026 | Original application | Tentative approval |
| Sitagliptin PhosphateEQ 50MG BASE · tablet;oral | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin PhosphateEQ 100MG BASE · tablet;oral | Sitagliptin Phosphate | None (tentative approval) |
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
