Product Details for: Gammagard, Gammagard S/D, Iveegam
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
0.5G
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
002
For Injection
Intravenous
1000MG
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
003
For Injection
Intravenous
2500MG
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
004
For Injection
Intravenous
500MG
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
005
For Injection
Intravenous
5000MG
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
006
For Injection
Intravenous
10G
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Rx
007
For Injection
Intravenous
2.5G
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Disc
008
For Injection
Intravenous
5.0G
Single-Use Bottle
351(a)
Gammagard, Gammagard S/D, Iveegam
Rx
Proper Name
Immune Globulin Intravenous (Human)
Immune Globulin Intravenous (Human)
BLA Number
103133
103133
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
February 18, 1986
February 18, 1986
Date of First Licensure