ANDA 219248, held by Msn Laboratories Private Ltd. Lumateperone Tosylate.
As of Nov 15, 2026, ANDA 219248 (Lumateperone Tosylate), held by Msn Laboratories Private Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2025 | Original application | Tentative approval |
| Lumateperone Tosylate10.5MG · capsule | Lumateperone Tosylate | None (tentative approval) |
| Lumateperone Tosylate21MG · capsule | Lumateperone Tosylate | None (tentative approval) |
| Lumateperone Tosylate42MG · capsule | Lumateperone Tosylate | 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
