ANDA 211073, held by Macleods Pharms Ltd. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 211073 (Sitagliptin Phosphate), held by Macleods Pharms Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Original application | Tentative approval | None posted |
| Sitagliptin Phosphate25MG · tablet; oral | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin Phosphate50MG · tablet; oral | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin Phosphate100MG · 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
