APPLICATION
NDA212726
TYPE
NDA
ORIGINAL APPROVAL
2019-08-15
LATEST ACTION
2019-08-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ROZLYTREKPrescription
ENTRECTINIB 100MG · CAPSULE · ORAL
ROZLYTREKPrescription
ENTRECTINIB 200MG · CAPSULE · ORAL
Approval history
2019-08-15Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · priority — Label ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.