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Rylaze

asparaginase erwinia chrysanthemi (recombinant)-rywn

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rylaze

Proper name

asparaginase erwinia chrysanthemi (recombinant)-rywn

Licence type

351(a)

BLA number

761179

Applicant

Jazz Pharmaceuticals Ireland Limited

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
10MG/0.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	June 30, 2021

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