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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: urea
Date Designated: 11/07/2011
Orphan Designation: Treatment of rare congenital ichthyoses
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Orenova Group, LLC
10 New King Street
Suite 106
White Plains, New York 10604
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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