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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ascorbic acid
Trade Name: Ascor
Date Designated: 08/31/2007
Orphan Designation: Treatment of scurvy
Orphan Designation Status: Designated/Approved
McGuff Pharmaceuticals Inc.
2921 W. MacArthur Blvd.
Suite 141
Santa Ana, California 92704
United States

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

Marketing approved:

1 Generic Name: ascorbic acid
Trade Name: Ascor
Marketing Approval Date: 10/02/2017
Approved Labeled Indication: for the treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administrtaion is not possible, insufficient or contraindicated
Exclusivity End Date: 10/02/2024 
Exclusivity Protected Indication* :  for the treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administrtaion is not possible, insufficient or contraindicated
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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