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XTANDI

NDA · New Drug Application · Sponsor: ASTELLAS · Approved 2020-08-04

Drug application

FDA Application #

NDA213674

Application type

New Drug Application

Brand name

XTANDI

Generic name

ENZALUTAMIDE

Active ingredients

ENZALUTAMIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ASTELLAS

Manufacturer

Astellas Pharma US, Inc.

First approval

2020-08-04

Source

Authoritative

Drugs@FDA application overview

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