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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 citrate
Trade Name: Urocit-K
Date Designated: 11/01/1984
Orphan Designation: 1. Prevention of calcium renal stones in patients with hypocitraturia 2. For avoidance of the complication of calcium stone formation in patients with uric lithiasis.
Orphan Designation Status: Designated/Approved
University of Texas Health Science Center at Dallas
5323 Harry Hines Blvd
Dallas, Texas 75235
United States

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

Marketing approved:

1 Generic Name: Potassium citrate
Trade Name: Urocit-K
Marketing Approval Date: 08/07/1985
Approved Labeled Indication: Prevention of recurring calcium conating stines associated with a deficiency in the urine.
Exclusivity End Date: 08/07/1992 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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