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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Naltrexone HCl
Trade Name: Trexan
Date Designated: 03/11/1985
Orphan Designation: For blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified formerly opioid-dependent individuals.
Orphan Designation Status: Designated/Approved
DuPont Pharmaceuticals
E.I. Du Pont De Nemours & Co.
Wilmington, Delaware 19880
United States

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

Marketing approved:

1 Generic Name: Naltrexone HCl
Trade Name: Trexan
Marketing Approval Date: 11/30/1984
Approved Labeled Indication:
Exclusivity End Date: 11/30/1991 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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