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ROZLYTREK

NDA · New Drug Application · Sponsor: GENENTECH INC · Approved 2023-10-20

Drug application

FDA Application #

NDA218550

Application type

New Drug Application

Brand name

ROZLYTREK

Generic name

ENTRECTINIB

Active ingredients

ENTRECTINIB

Dosage form

PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

GENENTECH INC

Manufacturer

Genentech, Inc.

First approval

2023-10-20

Source

Authoritative

Drugs@FDA application overview

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