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Amevive

alefacept

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Amevive

Proper name

alefacept

Licence type

351(a)

BLA number

125036

Applicant

Astellas Pharma US, Inc.

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
15MG	For Injection	Intramuscular	Single-Dose Vial	Disc	January 30, 2003
7.5MG	For Injection	Intravenous	Single-Dose Vial	Disc	January 30, 2003

Sources for this page

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