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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bicarbonate infusate
Trade Name: Normocarb HF
Date Designated: 08/09/2005
Orphan Designation: Use in the management of patients undergoing continuous renal replacement therapy with hemofiltration
Orphan Designation Status: Designated/Approved
Dialysis Solutions, Inc.
14 Emmett Place
Whitby
Canada

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

Marketing approved:

1 Generic Name: bicarbonate infusate
Trade Name: Normocarb HF
Marketing Approval Date: 07/26/2006
Approved Labeled Indication: Use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace water and to correct electrolytes and acid-base imbalances in adults and children
Exclusivity End Date: 07/26/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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