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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (6R,S)5,10-methylene-tetrahydrofolic acid
Date Designated: 08/13/2004
Orphan Designation: For use in combination with 5-fluorouracil for the treatment of patients with pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Adventrx Pharmaceuticals, Inc.
6725 Mesa Ridge Road
Suite 100
San Diego, California 92121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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