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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
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
Cellectar Biosciences, Inc.
100 Campus Drive, Suite 207
Florham Park, New Jersey 07932
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.
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