Product Details for: Obizur
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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)
Obizur
Rx
Proper Name
Antihemophilic Factor (Recombinant), Porcine Sequence
Antihemophilic Factor (Recombinant), Porcine Sequence
BLA Number
125512
125512
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
October 23, 2014
October 23, 2014
Date of First Licensure