Product Details for: Hyqvia
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
10%
Bottle
351(a)
Hyqvia
Rx
Proper Name
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
BLA Number
125402
125402
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
September 12, 2014
September 12, 2014
Date of First Licensure