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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: peritoneal dialysis solution containing combination of D-glucose and L-carnitine
Date Designated: 02/21/2019
Orphan Designation: Treatment of patients with end stage renal disease who require peritoneal dialysis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CoreQuest Sagl
Stabile Suglio Via Cantonale 18
Manno TI, Tessin

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.