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Gamimune
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gamimune
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
101147
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10PCT | Injection | Intravenous | Vial | Disc | September 11, 1981 |
| 5PCT | Injection | Intravenous | Vial | Disc | September 11, 1981 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |