FDA NDA · NDA218550
ROZLYTREK
Sponsor: GENENTECH INC
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APPLICATION
NDA218550
TYPE
NDA
ORIGINAL APPROVAL
2023-10-20
LATEST ACTION
2026-10-01
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription
Products
ROZLYTREK · ReferencePrescription
ENTRECTINIB 50MG/PACKET · PELLETS · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →