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Gammaplex
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gammaplex
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125329
Applicant
Bio Products Laboratory Limited
Center
CBER
Presentations
7
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | February 6, 2017 |
| 10G/200ML | Injection | Intravenous | Single-Dose Vial | Disc | September 17, 2009 |
| 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | September 17, 2009 |
| 20G/200ML | Injection | Intravenous | Single-Dose Vial | Rx | February 6, 2017 |
| 20G/400ML | Injection | Intravenous | Single-Dose Vial | Disc | February 7, 2014 |
| 5G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | September 17, 2009 |
| 5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | February 6, 2017 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |