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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Kyowa Pharma Chemical Co Ltd to the U.S. FDA. Original Data : FDA Website

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    01 BIMATOPROST DRUG SUBSTANCE (1)

    02 DINOPROSTONE DRUG SUBSTANCE (1)

    03 GP531T DRUG SUBSTANCE (1)

    04 LATANOPROST (1)

    05 MISOPROSTOL DRUG SUBSTANCE (1)

    06 MISOPROSTOL HPMC DISPERSION (1)

    07 OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE (1)

    08 SODIUM SULFADIMETHOXINE (1)

    09 SULFADIMETHOXINE (1)

    10 TRANEXAMIC ACID DRUG SUBSTANCE (1)

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    01 DAIICHI FINE CHEMICAL CO LTD (4)

    02 KYOWA PHARMA CHEMICAL CO LTD (6)

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    01 Japan (10)

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    02 Inactive (5)

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    BIMATOPROST DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    21681
    N/A
    2008-06-10
    II
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    DINOPROSTONE DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    11274
    N/A
    1994-12-27
    II
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    GP531T DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Inactive
    22824
    N/A
    2009-05-29
    II
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    LATANOPROST

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    KYOWA PHARMA CHEMICAL...
    Active
    32989
    N/A
    2018-08-07
    II
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    MISOPROSTOL DRUG SUBSTANCE

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    DAIICHI FINE CHEMICAL...
    Inactive
    15044
    N/A
    2000-09-13
    II
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    MISOPROSTOL HPMC DISPERSION

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    DAIICHI FINE CHEMICAL...
    Inactive
    15068
    N/A
    2000-09-28
    II
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    OLOPATADINE HYDROCHLORIDE DRUG SUBS...

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    KYOWA PHARMA CHEMICAL...
    Active
    28389
    N/A
    2014-06-16
    II
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    SODIUM SULFADIMETHOXINE

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    DAIICHI FINE CHEMICAL...
    Inactive
    6003
    N/A
    1985-08-13
    II
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    SULFADIMETHOXINE

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    DAIICHI FINE CHEMICAL...
    Inactive
    5995
    N/A
    1985-08-13
    II
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    TRANEXAMIC ACID DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    26128
    Complete
    2016-05-27
    2016-05-23
    2012-06-05
    II
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