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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Merck Sante Sas to the U.S. FDA. Original Data : FDA Website

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    01 CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE (1)

    02 CRE 15876/A4 INTERMEDIATE (1)

    03 CRE 16257 DRUG SUBSTANCE (1)

    04 GLUCOPHAGE 850 MG, FILM-COATED TABLETS (1)

    05 GLUCOPHAGE XR 500 MG, PROLONGED RELEASE TABLETS – BULK (REDUCED MASS) (1)

    06 METFORMIN HYDROCHLORIDE (1)

    07 METFORMIN HYDROCHLORIDE DRUG SUBTANCE (1)

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    01 MERCK SANTE SAS (7)

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    01 France (7)

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    01 Active (4)

    02 Inactive (3)

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    01 Blank (7)

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    CALCIUM ACAMPROSATE NEW DRUG SUBSTA...

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    MERCK SANTE SAS
    Inactive
    11995
    N/A
    1996-06-10
    II
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    GLUCOPHAGE 850 MG, FILM-COATED TABL...

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    MERCK SANTE SAS
    Active
    33557
    N/A
    2019-02-19
    II
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    GLUCOPHAGE XR 500 MG, PROLONGED REL...

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    MERCK SANTE SAS
    Active
    34331
    N/A
    2019-12-13
    II
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    METFORMIN HYDROCHLORIDE

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    MERCK SANTE SAS
    Active
    5951
    N/A
    1985-08-09
    II
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    METFORMIN HYDROCHLORIDE DRUG SUBTAN...

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    MERCK SANTE SAS
    Active
    12670
    N/A
    1997-09-30
    II
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    CRE 15876/A4 INTERMEDIATE

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    MERCK SANTE SAS
    Inactive
    16184
    N/A
    2002-10-11
    II
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    CRE 16257 DRUG SUBSTANCE

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    MERCK SANTE SAS
    Inactive
    16185
    N/A
    2002-10-11
    II
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