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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  hydralazine - magnesium valproate
Date Designated:  03/17/2011
Orphan Designation:  Treatment of myelodysplastic syndrome
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Neolpharma S.A.DE C.V.
Boulevard de los Ferrocarriles 277
Mexico City

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.