General MedicationsORALStandard
ROZLYTREK
ENTRECTINIB
Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview ROZLYTREK is listed in Drugs@FDA under application 212726 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient ENTRECTINIB Form and strength CAPSULE;ORAL - 200MG Sponsor GENENTECH INC Submission history Latest submission status date: 2019-08-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview ROZLYTREK is listed in Drugs@FDA under application 212726 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ENTRECTINIB Form and strength CAPSULE;ORAL - 200MG Sponsor GENENTECH INC Submission history Latest submission status date: 2019-08-15 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.