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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: chenodiol
Trade Name: Chenix
Date Designated: 09/21/1984
Orphan Designation: For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age
Orphan Designation Status: Designated/Approved
901 Sawyer Road
Marietta, Georgia 30062
United States

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

Marketing approved:

1 Generic Name: chenodiol
Trade Name: Chenix
Marketing Approval Date: 07/28/1983
Approved Labeled Indication:
Exclusivity End Date: 07/28/1990 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.