Product Details for: Xembify

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
4GM MG/ML
Single-Dose Vial
351(a)
Xembify
Rx
002
Injection
Subcutaneous
10GM MG/ML
Single-Dose Vial
351(a)
Xembify
Rx
003
Injection
Subcutaneous
2GM MG/ML
Single-Dose Vial
351(a)
Xembify
Rx
004
Injection
Subcutaneous
1GM MG/ML
Single-Dose Vial
351(a)
Xembify
Rx
Proper Name
immune globulin subcutaneous, human-klhw
BLA Number
125683
Applicant
Grifols Therapeutics LLC
Original Approval Date
July 3, 2019
Date of First Licensure
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