← FDA DRUG APPROVALS

FDA NDA · NDA218550

ROZLYTREK

entrectinib

Sponsor: GENENTECH INC

APPLICATION
NDA218550
TYPE
NDA
ORIGINAL APPROVAL
2023-10-20
LATEST ACTION
2023-10-20
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

ROZLYTREK · ReferencePrescription
ENTRECTINIB 50MG/PACKET · PELLETS · ORAL

Approval history

2023-10-20Type 3 - New Dosage Form · Original · priority — Letter ↗AP
2023-10-20Type 3 - New Dosage Form · Supplement 1 · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

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