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Octagam
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Octagam
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125062
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Center
CBER
Presentations
9
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10% 10G | Injection | Intravenous | Single-Use Bottle | Rx | July 11, 2014 |
| 10% 20G | Injection | Intravenous | Single-Use Bottle | Rx | July 11, 2014 |
| 10% 2G | Injection | Intravenous | Single-Use Bottle | Rx | July 11, 2014 |
| 10% 5G | Injection | Intravenous | Single-Use Bottle | Rx | July 11, 2014 |
| 5% 1.0G | Injection | Intravenous | Single-Use Bottle | Rx | May 21, 2004 |
| 5% 10G | Injection | Intravenous | Single-Use Bottle | Rx | May 21, 2004 |
| 5% 2.5G | Injection | Intravenous | Single-Use Bottle | Rx | May 21, 2004 |
| 5% 25G | Injection | Intravenous | Single-Use Bottle | Rx | March 26, 2007 |
| 5% 5.0G | Injection | Intravenous | Single-Use Bottle | Rx | May 21, 2004 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 15, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |