FDA
Lumateperone Tosylate
The FDA lists this product in 7 strengths and forms.
Composition
- Active ingredients
- LUMATEPERONE TOSYLATE 42MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- LUMATEPERONE TOSYLATE 42MG · CapsuleANDA219248-003 · Tentative approval
- LUMATEPERONE TOSYLATE 10.5MG · CapsuleANDA219248-001 · Tentative approval
- LUMATEPERONE TOSYLATE 21MG · CapsuleANDA219248-002 · Tentative approval
- LUMATEPERONE TOSYLATE 14MG · CapsuleANDA219142-004 · Tentative approval
- LUMATEPERONE TOSYLATE 21MG · CapsuleANDA219142-002 · Tentative approval
- LUMATEPERONE TOSYLATE 28MG · CapsuleANDA219142-005 · Tentative approval
- LUMATEPERONE TOSYLATE 42MG · CapsuleThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219142.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Lumateperone Tosylate
- Dosage form
- Capsule
- Applicant
- Hetero Labs Limited
- Status
- Tentative approval
- FDA approval
- 19 May 2025
- Application
- ANDA219142-003