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Bivigam
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bivigam
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125389
Applicant
ADMA Biologics, Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10GM/100ML | Injection | Intravenous | Vial | Rx | December 19, 2012 |
| 5GM/50ML | Injection | Intravenous | Vial | Rx | December 19, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |