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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Chlorhexidine gluconate mouthrinse
Date Designated: 08/18/1986
Orphan Designation: For use in the amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Procter & Gamble Company
Sharon Wood Technical Center
11370 Reed Hartman Highway
Cincinnati, Ohio 45241
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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