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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dianeal peritoneal dialysis solution with 1.1% amino acids
Date Designated: 06/11/1992
Orphan Designation: For use as a nutritional supplement for the treatment of malnourishment in patients undergoing continuous ambulatory peritoneal dialysis.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Baxter Healthcare Corporation
1620 Waukegan Road
McGaw Park, Illinois 60085
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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