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ZYTIGA

NDA · New Drug Application · Sponsor: JANSSEN BIOTECH · Approved 2011-04-28

Drug application

FDA Application #

NDA202379

Application type

New Drug Application

Brand name

ZYTIGA

Generic name

ABIRATERONE ACETATE

Active ingredients

ABIRATERONE ACETATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN BIOTECH

Manufacturer

Janssen Biotech, Inc.

First approval

2011-04-28

Source

Authoritative

Drugs@FDA application overview

Machine

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