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Erwinaze

asparaginase Erwinia chrysanthemi

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Erwinaze

Proper name

asparaginase Erwinia chrysanthemi

Licence type

351(a)

BLA number

125359

Applicant

Jazz Pharmaceuticals, Inc.

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
10,000INTERNATIONAL UNITS	For Injection	Intravenous, Intramuscular	Single-Dose Vial	Disc	November 18, 2011

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