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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Croda Europe Limited

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    01 Diethylstilbestrol (1)

    02 Ethanol (1)

    03 Lanolin (1)

    04 Omega-3 (2)

    05 Omega-3-Acid Ethyl Esters 90 (2)

    06 Tripalmitolein (1)

    07 Vitamin E (1)

    08 Blank (2)

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    01 Active (1)

    02 Inactive (2)

    03 Blank (8)

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    01 Valid (8)

    02 Withdrawn by Holder (1)

    03 Blank (2)

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    01 302MF10071 (1)

    02 Blank (10)

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    01 Blank (11)

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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Found USDMF

    22106
    Active
    OMEGA-3-ACID ETHYL ESTERS
    2008-10-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-057 - Rev 00
    Valid
    Omega-3-acid ethyl esters 90, Grade...
    2020-07-16
    Japanese DMF

    Found JDMF

    302MF10071
    Omega-3-Fatty Acid Ethyl Ester 90 O...
    2020-06-26
    Written Confirmation

    Close WC

    Application Number
    22106
    R1-CEP 2015-057 - Rev 00
    302MF10071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEGA-3-ACID ETHYL ESTERS
    Omega-3-acid ethyl esters 90, Grade...
    Omega-3-Fatty Acid Ethyl Ester 90 O...
    Issue/Submission Date
    2008-10-17
    2020-07-16
    2020-06-26
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    • FDA
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    Diethylstilbestrol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-265 - Rev 00
    Valid
    Omega-3-acid triglycerides, Grade S...
    2014-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-265 - Rev 00
    Status
    Valid
     
    Filing Details
    Omega-3-acid triglycerides, Grade S...
    Issue/Submission Date
    2014-09-04
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    Ethanol

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2001-382 - Rev 01
    Valid
    Wool Alcohols, Product codes: LD048...
    2015-10-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-382 - Rev 01
    Status
    Valid
     
    Filing Details
    Wool Alcohols, Product codes: LD048...
    Issue/Submission Date
    2015-10-20
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    Lanolin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-247 - Rev 01
    Valid
    Wool fat, (Product codes: LA04918, ...
    2015-10-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-247 - Rev 01
    Status
    Valid
     
    Filing Details
    Wool fat, (Product codes: LA04918, ...
    Issue/Submission Date
    2015-10-20
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    Omega-3

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-130 - Rev 00
    Valid
    Omega-3-acid ethyl esters 90, RF080...
    2021-08-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-130 - Rev 00
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, RF080...
    Issue/Submission Date
    2021-08-06
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    • FDA
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    Omega-3

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2007-366 - Rev 03
    Valid
    Omega-3-acid triglycerides, SF07200...
    2023-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2007-366 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid triglycerides, SF07200...
    Issue/Submission Date
    2023-10-06
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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 2015-267 - Rev 00
    Valid
    Omega-3-acid ethyl esters 90, RF082...
    2020-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-267 - Rev 00
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, RF082...
    Issue/Submission Date
    2020-10-26
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    • FDA
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    Vitamin E

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-419 - Rev 03
    Valid
    Omega-3-acid triglycerides, Grade S...
    2016-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-419 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid triglycerides, Grade S...
    Issue/Submission Date
    2016-08-12
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    • FDA
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    Tripalmitolein

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-233 - Rev 01
    Withdrawn by Holder
    Omega-3-acid triglycerides, Grade R...
    2007-10-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2000-233 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Omega-3-acid triglycerides, Grade R...
    Issue/Submission Date
    2007-10-24
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    • FDA
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    MANUFACTURING FACILITIES AND OPERATING PROCEDURES IN LE...

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    USDMF

    Caution USDMF

    10368
    Inactive
    MANUFACTURING FACILITIES AND OPERAT...
    1993-07-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10368
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING FACILITIES AND OPERAT...
    Issue/Submission Date
    1993-07-20
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