Search Orphan Drug Designations and Approvals
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Generic Name: | Intraoral fluoride releasing system |
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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 |
Sponsor: |
Digestive Care, Inc. 1120 Win Drive Bethlehem, Pennsylvania 18017 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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