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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Citric acid, glucono-delta-lactone and magnesium carbonate
Trade Name: Renacidin Irrigation
Date Designated: 08/28/1989
Orphan Designation: Treatment of renal and bladder calculi of the apatite or struvite variety.
Orphan Designation Status: Designated/Approved
United-Guardian, Inc.
P.O. Box 2500
Smithtown, New York 11787
United States

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

Marketing approved:

1 Generic Name: Citric acid, glucono-delta-lactone and magnesium carbonate
Trade Name: Renacidin Irrigation
Marketing Approval Date: 10/02/1990
Approved Labeled Indication:
Exclusivity End Date: 10/02/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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