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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Lactic acid
Date Designated: 06/29/1999
Orphan Designation: Treatment of severe aphthous stomatitis in severely, terminally immunocompromised patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Frontier Pharmaceutical, Inc.
SUNY Farmingdale
Conklin Hall
Farmingdale, New York 11735
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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