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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ethanolamine
Date Designated: 01/17/2014
Orphan Designation: Prophylactic use in pediatric patients (age 0 through 16 years) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
QOL Medical, LLC
4445 North Highway A1A, 241
Vero Beach, Florida 32963
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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