ANDA 216919, held by Mankind Pharma Ltd. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 216919 (Sitagliptin), held by Mankind Pharma Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 2, 2024 | Original application | Tentative approval |
| Sitagliptin25MG · tablet; film coated | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin50MG · tablet; film coated | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin100MG · tablet; film coated | 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