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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Amiodarone HCl
Trade Name: Cordarone
Date Designated: 03/16/1994
Orphan Designation: For the acute treatment and prophylaxis of life-threatening ventricular tachycardia or ventricular fibrillation.
Orphan Designation Status: Designated/Approved
Wyeth-Ayerst Laboratories
P.O. Box 8299
Philadelphia, Pennsylvania 19101
United States

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

Marketing approved:

1 Generic Name: Amiodarone HCl
Trade Name: Cordarone
Marketing Approval Date: 08/03/1995
Approved Labeled Indication: For initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
Exclusivity End Date: 08/03/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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