Generic Companies with Tentative Approvals for: lumateperone
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lumateperone Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
| Applicant | Generic Name | NDA | Strength | Dosage Form |
|---|---|---|---|---|
| Aurobindo Pharma Limited | lumateperone | 219085 | 21MG | CAPSULE |
| Dr. Reddy's Laboratories Limited | lumateperone | 219229 | 21MG | CAPSULE |
| Msn Laboratories Private Ltd | lumateperone tosylate | 219248 | 42MG | CAPSULE |
| Aurobindo Pharma Limited | lumateperone | 219085 | 42MG | CAPSULE |
| Msn Laboratories Private Ltd | lumateperone tosylate | 219248 | 14MG | CAPSULE |
| Hetero Labs Limited | lumateperone tosylate | 219142 | 28MG | CAPSULE |
| Msn Laboratories Private Ltd | lumateperone tosylate | 219248 | 28MG | CAPSULE |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
