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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: dopamine hydrochloride
Date Designated: 10/24/2017
Orphan Designation: Prevention of intraventricular hemorrhage in hypotensive premature neonates
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Brepco Biopharma, Ltd.
1785 Old Mill Road
Bethlehem, Pennsylvania 18015
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.