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Darzalex

daratumumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Darzalex

Proper name

daratumumab

Licence type

351(a)

BLA number

761036

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG/5ML	Injection	Intravenous	Single-Dose Vial	Rx	November 16, 2015
400MG/20ML	Injection	Intravenous	Single-Dose Vial	Rx	November 16, 2015

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 26, 2026

Sources for this page

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