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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by K.d. Pharma Bexbach Gmbh

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    K.D. Pharma Bexbach GmbH

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    01 Icosapent Ethyl (2)

    02 Omega-3 (1)

    03 Omega-3-Acid Ethyl Esters 90 (5)

    04 Blank (1)

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    01 Active (3)

    02 Inactive (1)

    03 Blank (5)

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    01 Valid (5)

    02 Blank (4)

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    01 228MF10081 (1)

    02 Blank (8)

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    01 Blank (9)

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    • FDA
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    Icosapent Ethyl

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    USDMF

    Found USDMF

    26892
    Active
    EICOSAPENTAENOIC ACID ETHYL ESTER
    2013-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10081
    Eicosapentaenoic acid ethyl at Am K...
    2016-04-06
    Written Confirmation

    Close WC

    Application Number
    26892
    228MF10081
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EICOSAPENTAENOIC ACID ETHYL ESTER
    Eicosapentaenoic acid ethyl at Am K...
    Issue/Submission Date
    2013-02-26
    2016-04-06
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    Icosapent Ethyl

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    USDMF

    Found USDMF

    28140
    Active
    EPA 550/DHA 200 FFA
    2014-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    28140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPA 550/DHA 200 FFA
    Issue/Submission Date
    2014-03-31
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    Omega-3

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    USDMF

    Found USDMF

    22100
    Active
    OMEGA-3 ACIDS ETHYL ESTERS USP
    2008-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    22100
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OMEGA-3 ACIDS ETHYL ESTERS USP
    Issue/Submission Date
    2008-11-07
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-326 - Rev 01
    Valid
    Omega-3-acid ethyl esters 60, Conta...
    2016-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-326 - Rev 01
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 60, Conta...
    Issue/Submission Date
    2016-03-03
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-328 - Rev 03
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-328 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-24
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-042 - Rev 00
    Valid
    Omega-3-acid ethyl esters 60, Conta...
    2015-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-042 - Rev 00
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 60, Conta...
    Issue/Submission Date
    2015-12-14
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-118 - Rev 01
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-118 - Rev 01
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-16
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-327 - Rev 03
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-327 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-30
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    • FDA
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    OMEGA-3-ACIDS ETHYL ESTER

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    USDMF

    Caution USDMF

    23905
    Inactive
    OMEGA-3-ACIDS ETHYL ESTER
    2010-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23905
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OMEGA-3-ACIDS ETHYL ESTER
    Issue/Submission Date
    2010-07-12
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