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Campath

alemtuzumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Campath

Proper name

alemtuzumab

Licence type

351(a)

BLA number

103948

Applicant

Genzyme Corporation

Center

CDER

Presentations

2

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
30MG (10MG/ML)	Injection	Intravenous	Ampule	Disc	May 7, 2001
30MG/1ML	Injection	Intravenous	Single-Dose Vial	Rx	October 12, 2004

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 7, 2008

Sources for this page

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