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Stelara

ustekinumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Stelara

Proper name

ustekinumab

Licence type

351(a)

BLA number

761044

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

5

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
130MG/26ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 23, 2016
45MG/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Rx	September 25, 2009
45MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	December 30, 2009
90MG/ML	Injection	Subcutaneous	Single-Dose Vial	Disc	September 25, 2009
90MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	December 30, 2009

Sources for this page

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