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Report / Drug application metadata

ROZLYTREK

The application NDA218550 lists 1 product formulation. Its sponsor is GENENTECH INC. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

ROZLYTREK

Active ingredients
ENTRECTINIB 50MG/PACKET
Dosage form
PELLETS
Route
ORAL
Marketing status
Prescription
Product number
001

How should this information be used?

An application can contain several product versions and a history of submissions. The details shown here do not establish current availability in a particular country or pharmacy, and a listed strength is not a recommended dose. Check the current approved product label for indications, contraindications, warnings and dosing.

This page does not infer a medicine's treatment uses from its name or regulatory status. Application metadata is evidence about the listed product, not evidence that it is suitable for an individual patient.

Kind
Drug application metadata
Identifier
NDA218550
Sponsor
GENENTECH INC

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