ANDA 216086, held by Msn Laboratories Private Ltd. Sitagliptin Phosphate.
As of Nov 15, 2026, ANDA 216086 (Sitagliptin), held by Msn Laboratories Private Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2025 | Original application | Tentative approval | None posted |
| 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
