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Vivaglobin
Immune Globulin Subcutaneous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vivaglobin
Proper name
Immune Globulin Subcutaneous (Human)
Licence type
351(a)
BLA number
125115
Applicant
CSL Behring GmbH
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 160MG/ML | For Injection | Subcutaneous | Vial | Disc | January 9, 2006 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |