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Flebogamma 5%, Flebogamma 5% Dif
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Flebogamma 5%, Flebogamma 5% Dif
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125077
Applicant
Instituto Grifols, S.A.
Center
CBER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5G/10ML | Injection | Intravenous | Single-Dose Vial | Disc | December 15, 2003 |
| 10G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | July 27, 2010 |
| 10G/200ML | Injection | Intravenous | Single-Dose Vial | Rx | December 15, 2003 |
| 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | December 15, 2003 |
| 20G/200ML | Injection | Intravenous | Single-Dose Vial | Disc | July 27, 2010 |
| 20G/400ML | Injection | Intravenous | Single-Dose Vial | Rx | December 21, 2006 |
| 5G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | December 15, 2003 |
| 5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | July 27, 2010 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |