Product Details for: Hizentra

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
2G/10ML
Single-Dose Vial
351(a)
Hizentra
Rx
002
Injection
Subcutaneous
1G/5ML
Single-Dose Vial
351(a)
Hizentra
Rx
003
Injection
Subcutaneous
10G/50ML
Single-Dose Vial
351(a)
Hizentra
Rx
004
Injection
Subcutaneous
4G/20ML
Single-Dose Vial
351(a)
Hizentra
Rx
005
Injection
Subcutaneous
1G/5ML
Pre-Filled Syringe
351(a)
Hizentra
Rx
006
Injection
Subcutaneous
2G/10ML
Pre-Filled Syringe
351(a)
Hizentra
Rx
007
Injection
Subcutaneous
4G/20ML
Pre-Filled Syringe
351(a)
Hizentra
Rx
008
Injection
Subcutaneous
10G/50ML
Pre-Filled Syringe
351(a)
Hizentra
Rx
Proper Name
Immune Globulin Subcutaneous (Human), 20% Liquid
BLA Number
125350
Applicant
CSL Behring AG
Original Approval Date
March 4, 2010
Date of First Licensure
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