Product Details for: Erwinaze
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous, Intramuscular
10,000INTERNATIONAL UNITS
Single-Dose Vial
351(a)
Erwinaze
Disc
Proper Name
asparaginase Erwinia chrysanthemi
asparaginase Erwinia chrysanthemi
BLA Number
125359
125359
Applicant
Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc.
Original Approval Date
November 18, 2011
November 18, 2011
Date of First Licensure