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Hepagam B
Hepatitis B Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hepagam B
Proper name
Hepatitis B Immune Globulin (Human)
Licence type
351(a)
BLA number
125035
Applicant
Kamada Ltd.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| >1560IU/5ML | Injection | Intramuscular | Single-Dose Vial | Rx | January 27, 2006 |
| >312IU/ML | Injection | Intramuscular | Single-Dose Vial | Rx | January 27, 2006 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 6, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |