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Soliris

eculizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Soliris

Proper name

eculizumab

Licence type

351(a)

BLA number

125166

Applicant

Alexion Pharmaceuticals, Inc.

Center

CDER

Presentations

1

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
300MG/30ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 16, 2007

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 28, 1932

Sources for this page

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