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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi Ag

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    Fresenius Kabi AG

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    01 Ampicillin Sodium (1)

    02 Cefalotin sodium Sterile (1)

    03 Cefatrizine (1)

    04 Docetaxel (1)

    05 Gemcitabine (1)

    06 Irinotecan Hydrochloride (1)

    07 Blank (1)

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    01 Inactive (1)

    02 Blank (6)

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    01 Valid (1)

    02 Withdrawn by Holder (2)

    03 Blank (4)

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    01 224MF10032 (1)

    02 224MF10181 (1)

    03 225MF10038 (1)

    04 Blank (4)

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    01 Blank (7)

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    Ampicillin Sodium

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2007-227 - Rev 04
    Valid
    Ampicillin sodium, Sterile
    2021-02-11
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    Application Number
    R1-CEP 2007-227 - Rev 04
    Status
    Valid
     
    Filing Details
    Ampicillin sodium, Sterile
    Issue/Submission Date
    2021-02-11
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    Docetaxel

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    224MF10181
    Docetaxel at Echelon Institutional ...
    2012-08-28
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    Application Number
    224MF10181
    Status
     
    Filing Details
    Docetaxel at Echelon Institutional ...
    Issue/Submission Date
    2012-08-28
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    Gemcitabine

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    USDMF

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    CEP/COS

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    224MF10032
    Gemcitabine hydrochloride at Echelo...
    2012-02-15
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    Application Number
    224MF10032
    Status
     
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    Gemcitabine hydrochloride at Echelo...
    Issue/Submission Date
    2012-02-15
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    Irinotecan Hydrochloride

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    USDMF

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    CEP/COS

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    225MF10038
    Irinotecan Hydrochloride Trihydrate...
    2013-02-20
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    Application Number
    225MF10038
    Status
     
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    Irinotecan Hydrochloride Trihydrate...
    Issue/Submission Date
    2013-02-20
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    Cefalotin sodium Sterile

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    USDMF

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    CEP/COS

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    R1-CEP 2004-227 - Rev 03
    Withdrawn by Holder
    Cefalotin sodium, Sterile
    2019-04-24
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    Application Number
    R1-CEP 2004-227 - Rev 03
    Status
    Withdrawn by Holder
     
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    Cefalotin sodium, Sterile
    Issue/Submission Date
    2019-04-24
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    Cefatrizine

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    USDMF

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    CEP/COS

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    R1-CEP 1999-142 - Rev 05
    Withdrawn by Holder
    Cefatrizine propylene glycol
    2019-04-24
    Japanese DMF

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    Application Number
    R1-CEP 1999-142 - Rev 05
    Status
    Withdrawn by Holder
     
    Filing Details
    Cefatrizine propylene glycol
    Issue/Submission Date
    2019-04-24
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

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    5201
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1984-01-03
    CEP/COS

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    Application Number
    5201
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1984-01-03
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