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Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5
Albumin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
101138
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 12.5G/250ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 12.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 2.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 20G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 25G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 25G/500ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
| 5G/20ML | For Injection | Intravenous | Single-Dose Vial | Rx | October 21, 1942 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |