Product Details for: Elaprase
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
6MG/3ML (2MG/ML)
Single-Dose Vial
351(a)
Elaprase
Rx
Proper Name
idursulfase
idursulfase
BLA Number
125151
125151
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
July 24, 2006
July 24, 2006
Date of First Licensure