Product Details for: Gammaked, Gamunex-C

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2.5G/25ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
002
Injection
Intravenous
5G/50ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
003
Injection
Intravenous
10G/100ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
004
Injection
Intravenous
1G/10ML
Bottle
351(a)
Gammaked, Gamunex-C
Rx
005
Injection
Intravenous
20G/200ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
006
Injection
Intravenous
40G/400ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
007
Injection
Subcutaneous
2.5G/25ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
008
Injection
Subcutaneous
5G/50ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
009
Injection
Subcutaneous
10G/100ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
010
Injection
Subcutaneous
20G/200ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
011
Injection
Subcutaneous
40G/400ML
Single-Use Bottle
351(a)
Gammaked, Gamunex-C
Rx
012
Injection
Intravenous
40G/400ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
013
Injection
Intravenous
20G/200ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
014
Injection
Intravenous
10G/100ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
015
Injection
Intravenous
5G/50ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
016
Injection
Subcutaneous
40G/400ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
017
Injection
Subcutaneous
20G/200ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
018
Injection
Subcutaneous
10G/100ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
019
Injection
Subcutaneous
5G/50ML
Bag
351(a)
Gammaked, Gamunex-C
Rx
Proper Name
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
BLA Number
125046
Applicant
Grifols Therapeutics LLC
Original Approval Date
August 27, 2003
Date of First Licensure
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