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DARZALEX FASPRO

BLA · Biologics License Application · Sponsor: JANSSEN BIOTECH · Approved 2020-05-01

Drug application

FDA Application #

BLA761145

Application type

Biologics License Application

Brand name

DARZALEX FASPRO

Generic name

DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)

Active ingredients

DARATUMUMAB AND HYALURONIDASE-FIHJ

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

JANSSEN BIOTECH

Manufacturer

Janssen Biotech, Inc.

First approval

2020-05-01

Source

Authoritative

Drugs@FDA application overview

Machine

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