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Tremfya

guselkumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Tremfya

Proper name

guselkumab

Licence type

351(a)

BLA number

761061

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

6

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/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	July 13, 2017
100MG/ML	Injection	Subcutaneous	Autoinjector	Rx	January 28, 2019
100MG/ML	Injection	Subcutaneous	Autoinjector	Rx	March 25, 2025
200MG/20ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 11, 2024
200MG/2ML (100MG/ML)	Injection	Subcutaneous	Autoinjector	Rx	September 11, 2024
200MG/2ML (100MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	September 11, 2024

Sources for this page

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