Product Details for: Bivigam
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
5GM/50ML
Vial
351(a)
Bivigam
Rx
002
Injection
Intravenous
10GM/100ML
Vial
351(a)
Bivigam
Rx
Proper Name
Immune Globulin Intravenous (Human)
Immune Globulin Intravenous (Human)
BLA Number
125389
125389
Applicant
ADMA Biologics, Inc.
ADMA Biologics, Inc.
Original Approval Date
December 19, 2012
December 19, 2012
Date of First Licensure