Search Orphan Drug Designations and Approvals
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Generic Name: | Sterile Bicarbonate Infusate, Hemofiltration, Hemodiafiltration, and Hemopdialysis Solution |
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Date Designated: | 05/29/2009 |
Orphan Designation: | For use as a replacement solution in adults and children during Continous Renal Replacement Therapy |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Nikkiso America, Inc. 5910 Pacific Center Blvd Suite 110 San Diego, California 92121 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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