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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Benzydamine hydrochloride
Date Designated: 05/18/1998
Orphan Designation: Prophylactic treatment of oral mucositis resulting from radiation therapy for head and neck cancer.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Angelini Pharmaceuticals, Inc.
70 Grand Avenue
River Edge, New Jersey 07661
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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