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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
Date Designated:  03/25/2019
Orphan Designation:  Treatment of ectopic pregnancy
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Antares Pharma, Inc
Princeton Crossroads Corporate Center
100 Princeton South Suite 300
Ewing,, New Jersey 08628
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.