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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-acetylcysteine
Date Designated: 09/09/2002
Orphan Designation: Treatment of acute liver failure
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cumberland Pharmaceuticals, Inc.
2525 West End Ave.
Suite 950
Nashville, Tennessee 37203
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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