Product Details for: Flebogamma 5%, Flebogamma 5% Dif

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
0.5G/10ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Disc
002
Injection
Intravenous
2.5G/50ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Disc
003
Injection
Intravenous
5G/100ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Rx
004
Injection
Intravenous
10G/200ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Rx
005
Injection
Intravenous
20G/400ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Rx
006
Injection
Intravenous
5G/50ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Disc
007
Injection
Intravenous
10G/100ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Disc
008
Injection
Intravenous
20G/200ML
Single-Dose Vial
351(a)
Flebogamma 5%, Flebogamma 5% Dif
Disc
Proper Name
Immune Globulin Intravenous (Human)
BLA Number
125077
Applicant
Instituto Grifols, S.A.
Original Approval Date
December 15, 2003
Date of First Licensure
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