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Ilallinckrodt February 22,2012United States Nuclear Regulatory Commission Region III Nuclear Materials Licensing Branch 2443 Greenville Road, STE 210 Lisle, IL 605324352RE: License No: 241745001,

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What is mallinckrodt amendment request to?

The Mallinckrodt amendment request is submitted to regulatory authorities for approval of changes to a drug product.

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The manufacturer or sponsor of the drug product is required to file the Mallinckrodt amendment request.

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The Mallinckrodt amendment request is typically filled out by providing detailed information on the proposed changes to the drug product.

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The purpose of the Mallinckrodt amendment request is to seek approval for changes to a drug product that may impact its safety, efficacy, or quality.

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The Mallinckrodt amendment request must include information on the proposed changes, supporting data, and any potential risks or benefits.

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