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XTANDI

NDA · New Drug Application · Sponsor: ASTELLAS · Approved 2012-08-31

Drug application

FDA Application #

NDA203415

Application type

New Drug Application

Brand name

XTANDI

Generic name

ENZALUTAMIDE

Active ingredients

ENZALUTAMIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ASTELLAS

Manufacturer

Astellas Pharma US, Inc.

First approval

2012-08-31

Source

Authoritative

Drugs@FDA application overview

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