Product Details for: gammar i.v.,gammar-p i.v.
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
10G
Vial
351(a)
gammar i.v.,gammar-p i.v.
Disc
002
For Injection
Intravenous
5G
Vial
351(a)
gammar i.v.,gammar-p i.v.
Disc
003
For Injection
Intravenous
2.5G
Vial
351(a)
gammar i.v.,gammar-p i.v.
Disc
004
For Injection
Intravenous
1G
Vial
351(a)
gammar i.v.,gammar-p i.v.
Disc
Proper Name
Immune Globulin Intravenous (Human)
Immune Globulin Intravenous (Human)
BLA Number
103956
103956
Applicant
CSL Behring LLC
CSL Behring LLC
Original Approval Date
March 17, 2000
March 17, 2000
Date of First Licensure