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Darzalex Faspro

daratumumab and hyaluronidase-fihj

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Darzalex Faspro

Proper name

daratumumab and hyaluronidase-fihj

Licence type

351(a)

BLA number

761145

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	May 1, 2020

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 15, 2028

Purple Book	FDA	Licence type, presentations, reference product, exclusivity