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LAZCLUZE

NDA · New Drug Application · Sponsor: JANSSEN BIOTECH · Approved 2024-08-19

Drug application

FDA Application #

NDA219008

Application type

New Drug Application

Brand name

LAZCLUZE

Generic name

LAZERTINIB

Active ingredients

LAZERTINIB MESYLATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN BIOTECH

Manufacturer

Janssen Biotech, Inc.

First approval

2024-08-19

Source

Authoritative

Drugs@FDA application overview

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