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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Intraoral fluoride releasing system
Date Designated: 07/31/2001
Orphan Designation: Prevention of dental caries due to radiation-induced xerostomia in patients with head and neck cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Digestive Care, Inc.
1120 Win Drive
Bethlehem, Pennsylvania 18017
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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