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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Merck Sante Sas

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    01 Acamprosate Calcium (1)

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    Metformin

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    USDMF

    Found USDMF

    5951
    Active
    METFORMIN HYDROCHLORIDE
    1985-08-09
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-029 - Rev 05
    Valid
    Metformin Hydrochloride
    2018-10-18
    Japanese DMF

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    Application Number
    5951
    R1-CEP 1997-029 - Rev 05
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    METFORMIN HYDROCHLORIDE
    Metformin Hydrochloride
    Issue/Submission Date
    1985-08-09
    2018-10-18
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    Acamprosate Calcium

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    USDMF

    Caution USDMF

    11995
    Inactive
    CALCIUM ACAMPROSATE NEW DRUG SUBSTA...
    1996-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-125 - Rev 00
    Valid
    Acamprosate calcium
    2012-11-23
    Japanese DMF

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    Written Confirmation

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    Application Number
    11995
    R1-CEP 2007-125 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CALCIUM ACAMPROSATE NEW DRUG SUBSTA...
    Acamprosate calcium
    Issue/Submission Date
    1996-06-10
    2012-11-23
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    Gevatran

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2003-189 - Rev 01
    Valid
    Naftidrofuryl hydrogen oxalate
    2023-06-28
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    Application Number
    R1-CEP 2003-189 - Rev 01
    Status
    Valid
     
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    Naftidrofuryl hydrogen oxalate
    Issue/Submission Date
    2023-06-28
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    Metformin

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    USDMF

    Found USDMF

    12670
    Active
    METFORMIN HYDROCHLORIDE DRUG SUBTAN...
    1997-09-30
    CEP/COS

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    Application Number
    12670
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    METFORMIN HYDROCHLORIDE DRUG SUBTAN...
    Issue/Submission Date
    1997-09-30
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    Metformin

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    USDMF

    Found USDMF

    33557
    Active
    GLUCOPHAGE 850 MG, FILM-COATED TABL...
    2019-02-19
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    33557
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    GLUCOPHAGE 850 MG, FILM-COATED TABL...
    Issue/Submission Date
    2019-02-19
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    Metformin

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    USDMF

    Found USDMF

    34331
    Active
    GLUCOPHAGE XR 500 MG, PROLONGED REL...
    2019-12-13
    CEP/COS

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    Application Number
    34331
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    GLUCOPHAGE XR 500 MG, PROLONGED REL...
    Issue/Submission Date
    2019-12-13
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    CRE 15876/A4 INTERMEDIATE

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    USDMF

    Caution USDMF

    16184
    Inactive
    CRE 15876/A4 INTERMEDIATE
    2002-10-11
    CEP/COS

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    Japanese DMF

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    Application Number
    16184
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CRE 15876/A4 INTERMEDIATE
    Issue/Submission Date
    2002-10-11
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    CRE 16257 DRUG SUBSTANCE

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    USDMF

    Caution USDMF

    16185
    Inactive
    CRE 16257 DRUG SUBSTANCE
    2002-10-11
    CEP/COS

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    Japanese DMF

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    Application Number
    16185
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CRE 16257 DRUG SUBSTANCE
    Issue/Submission Date
    2002-10-11
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