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XOSPATA

NDA · New Drug Application · Sponsor: ASTELLAS · Approved 2018-11-28

Drug application

FDA Application #

NDA211349

Application type

New Drug Application

Brand name

XOSPATA

Generic name

GILTERITINIB

Active ingredients

GILTERITINIB FUMARATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ASTELLAS

Manufacturer

Astellas Pharma US, Inc.

First approval

2018-11-28

Source

Authoritative

Drugs@FDA application overview

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