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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
Date Designated: 08/17/1993
Orphan Designation: Treatment of incessant ventricular tachycardia.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Academic Pharmaceuticals, Inc.
21 N. Skokie Valley Highway
Suite G3
Lake Bluff, Illinois 60044
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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