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VYXEOS

NDA · New Drug Application · Sponsor: JAZZ PHARMS THERAP · Approved 2017-08-03

Drug application

FDA Application #

NDA209401

Application type

New Drug Application

Brand name

VYXEOS

Generic name

(DAUNORUBICIN AND CYTARABINE) LIPOSOME

Active ingredients

CYTARABINE; DAUNORUBICIN

Dosage form

POWDER

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

JAZZ PHARMS THERAP

Manufacturer

Jazz Pharmaceuticals, Inc.

First approval

2017-08-03

Source

Authoritative

Drugs@FDA application overview

Machine

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