Product Details for: Fabrazyme

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
35MG
Single-Dose Vial
351(a)
Fabrazyme
Rx
002
For Injection
Intravenous
5MG
Single-Dose Vial
351(a)
Fabrazyme
Rx
Proper Name
agalsidase beta
BLA Number
103979
Applicant
Genzyme Corporation
Original Approval Date
April 24, 2003
Date of First Licensure
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