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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: opium tincture
Date Designated: 12/02/2011
Orphan Designation: Treatment of chronic diarrhea in short bowel syndrome patients with an inadequate response to anti-diarrheal treatment
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Valeant Pharmaceuticals International, Inc.
400 Somerset Corporate Blvd
Bridgewater, New Jersey 08807
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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