ANDA 219142, held by Hetero Labs Limited. Lumateperone Tosylate.
As of Nov 15, 2026, ANDA 219142 (Lumateperone Tosylate), held by Hetero Labs Limited, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2025 | Original application | Tentative approval | None posted |
| Lumateperone Tosylate21MG · capsule | Lumateperone Tosylate | None (tentative approval) |
| Lumateperone Tosylate42MG · capsule | Lumateperone Tosylate | None (tentative approval) |
| Lumateperone Tosylate14MG · capsule | Lumateperone Tosylate | None (tentative approval) |
| Lumateperone Tosylate28MG · 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
