General MedicationsORALStandard
RESNIBEN
CABOZANTINIB
Standard Dose
13MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview RESNIBEN is listed in Drugs@FDA under application 220258 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CABOZANTINIB Form and strength TABLET; ORAL - 13MG Sponsor AZURITY Submission history Latest submission status date: 2025-10-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview RESNIBEN is listed in Drugs@FDA under application 220258 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CABOZANTINIB Form and strength TABLET; ORAL - 13MG Sponsor AZURITY Submission history Latest submission status date: 2025-10-24 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.