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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Metronidazole 10% ointment
Date Designated: 11/08/2007
Orphan Designation: Topical treatment of active perianal Crohn's disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SLA Pharma (UK) Ltd
Elite House
Hill Farm Industrial Estate
Watford WD25 7SA
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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