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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
Azcapotalco
Mexico City
Mexico

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.
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