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Kedbumin
Albumin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kedbumin
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
125384
Applicant
Kedrion Biopharma Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | June 3, 2011 |
| 25G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | September 5, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |