Skip to content

On this page

Benlysta

belimumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Benlysta

Proper name

belimumab

Licence type

351(a)

BLA number

125370

Applicant

GlaxoSmithKline LLC

Center

CDER

Presentations

4

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
120MG	For Injection	Intravenous	Single-Dose Vial	Rx	March 9, 2011
200MG/ML	Injection	Subcutaneous	Autoinjector	Rx	July 20, 2017
200MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	July 20, 2017
400MG	For Injection	Intravenous	Single-Dose Vial	Rx	March 9, 2011

Sources for this page

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