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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 oleate
Trade Name: Ethamolin
Date Designated: 03/22/1984
Orphan Designation: Treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.
Orphan Designation Status: Designated/Approved
QOL Medical
4445 North Highway A1A, 241
Vero Beach, Florida 32963
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Ethanolamine oleate
Trade Name: Ethamolin
Marketing Approval Date: 12/22/1988
Approved Labeled Indication:
Exclusivity End Date: 12/22/1995 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.