ANDA 216337, held by Sciegen Pharmaceuticals Inc. Sitagliptin.
As of Nov 15, 2026, ANDA 216337 (Sitagliptin), held by Sciegen Pharmaceuticals Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2025 | Original application | Tentative approval | None posted |
| Sitagliptin25MG · tablet; film coated | Sitagliptin | None (tentative approval) |
| Sitagliptin50MG · tablet; film coated | Sitagliptin | None (tentative approval) |
| Sitagliptin100MG · tablet; film coated | Sitagliptin | 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
