General MedicationsCAPSULEGeneric
LUMATEPERONE
LUMATEPERONE
Standard Dose
28MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview LUMATEPERONE is listed in Drugs@FDA under application 219229 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LUMATEPERONE Form and strength CAPSULE - 28MG Sponsor DR.
Structured Monograph
Clinical summary
Approval overview LUMATEPERONE is listed in Drugs@FDA under application 219229 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LUMATEPERONE Form and strength CAPSULE - 28MG Sponsor DR. REDDY'S LABORATORIES LIMITED Submission history Latest submission status date: 2025-08-06 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.