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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: 12/14/1987
Orphan Designation: Treatment of the neuroleptic malignant syndrome.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Norwich Eaton Pharmaceuticals
P.O. Box 191
Norwich, New York 13815
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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