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Albutein
Albumin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Albutein
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
102478
Applicant
Grifols Biologicals LLC
Center
CBER
Presentations
9
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 12.5ML/250ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 20G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 25G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 25G/500ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
| 5G/100ML | Injection | Intravenous | Bag | Disc | November 29, 2022 |
| 5G/20ML | Injection | Intravenous | Single-Dose Vial | Rx | August 15, 1978 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |