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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ibuprofen i.v. solution
Date Designated: 10/29/1996
Orphan Designation: Prevention of patent ductus arteriosus.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Farmacon-IL, LLC
1720 Post Road East
Suite 213
Westport, Connecticut 06880
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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