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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
Trade Name:  N/A
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
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Asklepion Pharmaceuticals, LLC
729 East Pratt Street
Suite 360
Baltimore, Maryland 21202

The sponsor address listed is the last reported by the sponsor to OOPD.