Search Orphan Drug Designations and Approvals
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Generic Name: | Hepatitis B immune globulin intravenous (human) |
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Date Designated: | 03/08/1995 |
Orphan Designation: | Prophylaxis against hepatitis B virus reinfection in liver transplant patients. |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Biotest Pharmaceuticals Corporation 5800 Park of Commerce Blvd., NW Boca Raton, Florida 33487 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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