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Provenge

sipuleucel-T

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Provenge

Proper name

sipuleucel-T

Licence type

351(a)

BLA number

125197

Applicant

Dendreon Pharmaceuticals LLC

Center

CBER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
50 M CD54 + ACTIVATED CELLS/250 ML	Injection	Intravenous	Bag	Rx	April 29, 2010

Sources for this page

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