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Enbrel

etanercept

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Enbrel

Proper name

etanercept

Licence type

351(a)

BLA number

103795

Applicant

Immunex Corporation

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
25MG	For Injection	Subcutaneous	Single-Dose Vial	Disc	November 2, 1998
25MG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	May 27, 1999
25MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	February 1, 2007
25MG/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Rx	March 5, 2020
50MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	September 27, 2004
50MG/ML	Injection	Subcutaneous	Autoinjector	Rx	—

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 27, 2006

Sources for this page

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