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Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized
Rho(D) Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized
Proper name
Rho(D) Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
103649
Applicant
Kamada Ltd.
Center
CBER
Presentations
18
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 15000IU | Injection | Intramuscular | Vial | Disc | March 31, 2005 |
| 15000IU | Injection | Intravenous | Vial | Disc | March 31, 2005 |
| 15000IU | Injection | Intravenous | Vial | Disc | December 18, 2015 |
| 15000IU | Injection | Intramuscular | Vial | Disc | December 18, 2015 |
| 1500IU | For Injection | Intramuscular | Vial | Disc | April 2, 1996 |
| 1500IU | For Injection | Intravenous | Vial | Disc | April 2, 1996 |
| 1500IU | Injection | Intramuscular | Vial | Rx | March 31, 2005 |
| 1500IU | Injection | Intravenous | Vial | Rx | March 31, 2005 |
| 2500IU | Injection | Intramuscular | Vial | Disc | March 31, 2005 |
| 2500IU | Injection | Intravenous | Vial | Disc | March 31, 2005 |
| 5000IU | For Injection | Intramuscular | Vial | Disc | April 2, 1996 |
| 5000IU | For Injection | Intravenous | Vial | Disc | April 2, 1996 |
| 5000IU | Injection | Intramuscular | Vial | Disc | March 31, 2005 |
| 5000IU | Injection | Intravenous | Vial | Disc | March 31, 2005 |
| 600IU | For Injection | Intramuscular | Vial | Disc | April 2, 1996 |
| 600IU | For Injection | Intravenous | Vial | Disc | April 2, 1996 |
| 600IU | Injection | Intramuscular | Vial | Disc | March 31, 2005 |
| 600IU | Injection | Intravenous | Vial | Disc | March 31, 2005 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 24, 2002 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |