Product Details for: Octagam

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
5% 5.0G
Single-Use Bottle
351(a)
Octagam
Rx
002
Injection
Intravenous
5% 1.0G
Single-Use Bottle
351(a)
Octagam
Rx
003
Injection
Intravenous
5% 10G
Single-Use Bottle
351(a)
Octagam
Rx
004
Injection
Intravenous
5% 2.5G
Single-Use Bottle
351(a)
Octagam
Rx
005
Injection
Intravenous
5% 25G
Single-Use Bottle
351(a)
Octagam
Rx
006
Injection
Intravenous
10% 20G
Single-Use Bottle
351(a)
Octagam
Rx
007
Injection
Intravenous
10% 5G
Single-Use Bottle
351(a)
Octagam
Rx
008
Injection
Intravenous
10% 2G
Single-Use Bottle
351(a)
Octagam
Rx
009
Injection
Intravenous
10% 10G
Single-Use Bottle
351(a)
Octagam
Rx
Proper Name
Immune Globulin Intravenous (Human)
BLA Number
125062
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
May 21, 2004
Date of First Licensure
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