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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: L-citrulline
Date Designated: 01/09/2017
Orphan Designation: Prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric patients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Asklepion Pharmaceuticals, LLC
729 East Pratt Street
Suite 360
Baltimore, Maryland 21202
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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