ANDA 208186, held by Zydus Pharms USA Inc. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 208186 (Sitagliptin Phosphate), held by Zydus Pharms USA Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 7, 2018 | Original application | Tentative approval | None posted |
| Sitagliptin PhosphateEQ 25MG BASE · tablet;oral | Sitagliptin Phosphate | None (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
