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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Potassium Iodide Oral Solution
Trade Name: ThyroShield
Date Designated: 11/17/2004
Orphan Designation: For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine
Orphan Designation Status: Designated/Approved
Fleming & Company, Pharmaceuticals
1733 Gilsinn Lane
Fenton, Missouri 63026
United States

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

Marketing approved:

1 Generic Name: Potassium Iodide Oral Solution
Trade Name: ThyroShield
Marketing Approval Date: 01/12/2005
Approved Labeled Indication: For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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