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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dantrolene sodium
Date Designated: 09/25/2012
Orphan Designation: Treatment of heat stroke
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Eagle Pharmaceuticals, Inc.
50 Tice Blvd
Suite 315
Woodcliff Lake, New Jersey 07677
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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