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Elitek

rasburicase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Elitek

Proper name

rasburicase

Licence type

351(a)

BLA number

103946

Applicant

Sanofi-Aventis U.S. LLC

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
1.5MG	For Injection	Intravenous	Single-Dose Vial	Rx	July 12, 2002
7.5MG	For Injection	Intravenous	Single-Dose Vial	Rx	January 6, 2006

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	July 12, 2009

Sources for this page

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