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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4,5 dibromorhodamine methyl ester
Date Designated: 10/23/2007
Orphan Designation: For immune reconstitution and prevention of graft versus host disease following allogeneic hematopoietic stem cell transplantation.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 12/02/2021
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kiadis Pharma Netherlands B.V.
Entrada 231 - 234
Amsterdam
Netherlands

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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