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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Trade Name:  N/A
Date Designated:  12/23/2019
Orphan Designation:  Treatment of Lymphoplasmacytic Lymphoma/Waldenstrom macroglobulinemia
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Cellectar Biosciences, Inc.
100 Campus Drive, Suite 207
Florham Park, New Jersey 07932

The sponsor address listed is the last reported by the sponsor to OOPD.