ANDA 218441, held by Biocon Pharma Ltd. Sitagliptin.
As of Nov 15, 2026, ANDA 218441 (Sitagliptin), held by Biocon Pharma Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2026 | Original application | Tentative approval | None posted |
| Sitagliptin50MG · tablet | Sitagliptin | None (tentative approval) |
| Sitagliptin100MG · tablet | 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