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Privigen
Immune Globulin Intravenous (Human), 10% Liquid
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Privigen
Proper name
Immune Globulin Intravenous (Human), 10% Liquid
Licence type
351(a)
BLA number
125201
Applicant
CSL Behring AG
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G | Injection | Intravenous | Single-Dose Vial | Rx | July 26, 2007 |
| 2.5G | Injection | Intravenous | Single-Dose Vial | Rx | October 2, 2009 |
| 20G | Injection | Intravenous | Single-Dose Vial | Rx | July 26, 2007 |
| 40G | Injection | Intravenous | Single-Dose Vial | Rx | February 7, 2013 |
| 5G | Injection | Intravenous | Single-Dose Vial | Rx | July 26, 2007 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |