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Arzerra

ofatumumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Arzerra

Proper name

ofatumumab

Licence type

351(a)

BLA number

125326

Applicant

Novartis Pharmaceuticals Corporation

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
1,000MG/50ML	Injection	Intravenous	Single-Dose Vial	Disc	April 1, 2011
100MG/5ML	Injection	Intravenous	Single-Dose Vial	Disc	October 26, 2009

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 19, 2023

Sources for this page

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