Search Orphan Drug Designations and Approvals
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Generic Name: | bicarbonate infusate | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Dialysis Solutions, Inc. 14 Emmett Place Whitby Canada The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | bicarbonate infusate |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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