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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Calcium gluconate gel
Date Designated: 05/21/1991
Orphan Designation: For use in the emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Calgonate Corporation
3310 South Ocean Blvd
Unit 132
Highland Beach, Florida 33487
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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