ANDA 217041, held by Fosun Wanbang (Jiangsu) Pharmaceutical Group Co.,. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 217041 (Sitagliptin), held by Fosun Wanbang (Jiangsu) Pharmaceutical Group Co.,, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2026 | Original application | Tentative approval | None posted |
| Sitagliptin50MG · tablet | Sitagliptin Phosphate | None (tentative approval) |
| Sitagliptin100MG · tablet | 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
