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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: acetylcysteine
Trade Name: Acetadote
Date Designated: 10/19/2001
Orphan Designation: For the intravenous treatment of moderate to severe acetaminophen overdose
Orphan Designation Status: Designated/Approved
Cumberland Pharmaceuticals, Inc.
209 10th Street South
Suite 332
Nashville, Tennessee 37203
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: acetylcysteine
Trade Name: Acetadote
Marketing Approval Date: 01/23/2004
Approved Labeled Indication: For the use of Acetadote(registered TM) Injection, administered intravenously within 8 to 10 hours after ingestion of a potentially heptotoxic quantity of acetaminophen, to prevent or lessen hepatic injur
Exclusivity End Date: 01/23/2011 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.