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 Product Approval Information - New Drug Application

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 (Text), (PDF)

Label - (PDF)

Last Updated: 3/22/2002

 

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Updated: September 26, 2003
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