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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Iobenguane Sulfate I 131
Trade Name:
Date Designated: 11/14/1984
Orphan Designation: For use as a diagnostic adjunct in patients with pheochromocytoma.
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
University of Michigan
UH B1 H410/0028
1500 E. Medical Center Drive
Ann Arbor, Michigan 48109
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: Iobenguane Sulfate I 131
Trade Name:
Marketing Approval Date: 03/25/1994
Approved Labeled Indication: Adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytomas.
Exclusivity End Date: 03/25/2001 
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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