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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Methotrexate sodium
Trade Name: Methotrexate
Date Designated: 10/21/1985
Orphan Designation: Treatment of osteogenic sarcoma.
Orphan Designation Status: Designated/Approved
Lederle Laboratories
Division of American Cyanamid Company
401 N. Middletown Road
Pearl River, New York 10965
United States

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

Marketing approved:

1 Generic Name: Methotrexate sodium
Trade Name: Methotrexate
Marketing Approval Date: 04/07/1988
Approved Labeled Indication: For the use of high dose methotrexate with leucovorin rescue in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.
Exclusivity End Date: 04/07/1995 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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