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    List of Drug Master Files (DMF) of Diphenoxylate Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Diphenoxylate Hydrochloride

    ACTIVE PHARMA INGREDIENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    PharmaCompass
    $ API Ref.Price (USD/KG) : 548Xls download

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 Veranova
    U.S.A
    		 VERANOVA LP 27700 DIPHENOXYLATE HCL 2014-01-20 Active II Complete 2015-09-03 2013-11-19
    26/09/2024 Mallinckrodt Pharmaceuticals
    Ireland
    		 SPECGX LLC 12441 DIPHENOXYLATE HYDROCHLORIDE USP 1997-03-31 Active II Complete 2014-05-22 2014-03-05