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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: hydrocortisone acetate
Date Designated: 06/27/2017
Orphan Designation: Treatment of pediatric ulcerative colitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cristcot HCA, LLC
555 Virginia Road
Suite 202
Concord, Massachusetts 01742
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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