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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Immune globulin intravenous (human)
Date Designated: 11/22/1993
Orphan Designation: Treatment of patients with acute myocarditis.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Immuno Clinical Research Corp.
750 Lexington Avenue, 19th Floor
New York, New York 10022
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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