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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
Date Designated:  04/09/2004
Orphan Designation:  Treatment of severe intrapartum hypertension (diastolic blood pressure greater than or equal to 110 or systolic blood pressure greater than or equal to 160) associated with severe preeclampsia/eclampsia of pregnancy
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Bioniche Pharma USA LLC
272 E. Deerpath Road
Suite 304
Lake Forest, Illinois 60045
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.