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

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    Butalbital

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

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    REF. STANDARDS & IMPURITIES

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    $ API Ref.Price (USD/KG) : 1,017Xls 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 Chemische Fabrik Berg
    Germany
    		 CHEMISCHE FABRIK BERG GMBH 4395 BUTALBITAL 1981-11-25 Active II Complete 2013-03-06 2013-02-20
    26/09/2024 Cambrex Corporation
    U.S.A
    		 CAMBREX CHARLES CITY INC 17054 BUTALBITAL 2003-12-12 Inactive II N/A