General MedicationsORALStandard
VRAYLAR
CARIPRAZINE HYDROCHLORIDE
Standard Dose
EQ 0.5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview VRAYLAR is listed in Drugs@FDA under application 204370 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient CARIPRAZINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 0.5MG BASE Sponsor ABBVIE Submission history Latest submission status date: 2025-12-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview VRAYLAR is listed in Drugs@FDA under application 204370 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient CARIPRAZINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 0.5MG BASE Sponsor ABBVIE Submission history Latest submission status date: 2025-12-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.