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U.S. Department of Health and Human Services

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Indium In-111 Product Approval Information - New Drug Application 2/19/02 (Supp 003)

Product name: Indium In-111 Chloride Solution
Manufacturer: Mallinckrodt, Inc, St. Louis, MO
Indication for Use: Use in radiolabeling Ibritumomab Tiuxetan (Zevalin) and remove use in radiolabeling Imciromab Pentetate (Myoscint)
Approval Date: 2/19/2002
Type of submission: New Drug Application Supplement

 


Approval Letter (PDF)

Label - (PDF)