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NERLYNX

NDA · New Drug Application · Sponsor: PUMA BIOTECH · Approved 2017-07-17

Drug application

FDA Application #

NDA208051

Application type

New Drug Application

Brand name

NERLYNX

Generic name

NERATINIB

Active ingredients

NERATINIB MALEATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

PUMA BIOTECH

Manufacturer

Puma Biotechnology, Inc.

First approval

2017-07-17

Source

Authoritative

Drugs@FDA application overview

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