General MedicationsORALStandard
CAPLYTA
LUMATEPERONE TOSYLATE
Standard Dose
EQ 21MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview CAPLYTA is listed in Drugs@FDA under application 209500 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LUMATEPERONE TOSYLATE Form and strength CAPSULE;ORAL - EQ 21MG BASE Sponsor INTRA-CELLULAR Submission history Latest submission status date: 2025-11-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview CAPLYTA is listed in Drugs@FDA under application 209500 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LUMATEPERONE TOSYLATE Form and strength CAPSULE;ORAL - EQ 21MG BASE Sponsor INTRA-CELLULAR Submission history Latest submission status date: 2025-11-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.