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  • ANDA 203263: Chemistry Reviews

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    This document contains chemistry reviews from the Center for Drug Evaluation and Research for ANDA 203263. The reviews were signed on April 23, 2012, November 1, 2012, and January 25, 2013 by reviewers Xiaobin Zhao, Frank J. Nice, and Radhika Rajagopalan, and Glen J. Smith. The reviews assessed the chemistry aspects of an abbreviated new drug application.

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    Doxil review document

    Original Title

    203263Orig1s000ChemR

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    This document contains chemistry reviews from the Center for Drug Evaluation and Research for ANDA 203263. The reviews were signed on April 23, 2012, November 1, 2012, and January 25, 2013 by reviewers Xiaobin Zhao, Frank J. Nice, and Radhika Rajagopalan, and Glen J. Smith. The reviews assessed the chemistry aspects of an abbreviated new drug application.

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    © All Rights Reserved
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    18 views48 pages

    ANDA 203263: Chemistry Reviews

    Uploaded by

    GraceJin
    This document contains chemistry reviews from the Center for Drug Evaluation and Research for ANDA 203263. The reviews were signed on April 23, 2012, November 1, 2012, and January 25, 2013 by reviewers Xiaobin Zhao, Frank J. Nice, and Radhika Rajagopalan, and Glen J. Smith. The reviews assessed the chemistry aspects of an abbreviated new drug application.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 48

    CENTER FOR DRUG EVALUATION AND RESEARCH

    APPLICATION NUMBER:

    ANDA 203263

    CHEMISTRY REVIEWS

    --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed


    electronically and this page is the manifestation of the electronic
    signature.
    --------------------------------------------------------------------------------------------------------/s/
    ---------------------------------------------------XIAOBIN ZHAO
    04/23/2012
    FRANK J NICE
    04/23/2012
    RADHIKA RAJAGOPALAN
    04/23/2012

    Reference ID: 3120399

    --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed


    electronically and this page is the manifestation of the electronic
    signature.
    --------------------------------------------------------------------------------------------------------/s/
    ---------------------------------------------------XIAOBIN ZHAO
    10/31/2012
    FRANK J NICE
    11/01/2012
    RADHIKA RAJAGOPALAN
    11/01/2012

    Reference ID: 3210825

    --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed


    electronically and this page is the manifestation of the electronic
    signature.
    --------------------------------------------------------------------------------------------------------/s/
    ---------------------------------------------------XIAOBIN ZHAO
    01/25/2013
    FRANK J NICE
    01/25/2013
    RADHIKA RAJAGOPALAN
    01/25/2013
    GLEN J SMITH
    01/25/2013

    Reference ID: 3249870

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