Product Details for: Cuvitru

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1G/5ML
Single-Dose Vial
351(a)
Cuvitru
Rx
002
Injection
Subcutaneous
2G/10ML
Single-Dose Vial
351(a)
Cuvitru
Rx
003
Injection
Subcutaneous
8G/40ML
Single-Dose Vial
351(a)
Cuvitru
Rx
004
Injection
Subcutaneous
4G/20ML
Single-Dose Vial
351(a)
Cuvitru
Rx
005
Injection
Subcutaneous
10G/50ML
Single-Dose Vial
351(a)
Cuvitru
Rx
Proper Name
Immune Globulin Subcutaneous (Human), 20% Solution
BLA Number
125596
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
September 13, 2016
Date of First Licensure
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