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)
BLA Number
125389
Applicant
ADMA Biologics, Inc.
Original Approval Date
December 19, 2012
Date of First Licensure