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Human Albumin Grifols
Albumin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Human Albumin Grifols
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
103352
Applicant
Instituto Grifols, S.A.
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | February 17, 1995 |
| 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | February 17, 1995 |
| 20G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | June 11, 2003 |
| 25G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | June 11, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |