Product Details for: Cinryze
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500U
Single-Dose Vial
351(a)
Cinryze
Rx
Proper Name
C1 Esterase Inhibitor (Human)
C1 Esterase Inhibitor (Human)
BLA Number
125267
125267
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
October 10, 2008
October 10, 2008
Date of First Licensure