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    12, Milano, MI 20139
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    • FDA
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    Paclitaxel

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    USDMF

    Found USDMF

    16242
    Active
    PACLITAXEL P.I.
    2002-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-320 - Rev 02
    Valid
    Paclitaxel, Isolated from natural s...
    2020-11-19
    Japanese DMF

    Found JDMF

    221MF10053
    Paclitaxel / S at Viale Ortles 12 M...
    2009-03-16
    Written Confirmation

    Close WC

    Application Number
    16242
    R1-CEP 2006-320 - Rev 02
    221MF10053
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL P.I.
    Paclitaxel, Isolated from natural s...
    Paclitaxel / S at Viale Ortles 12 M...
    Issue/Submission Date
    2002-11-13
    2020-11-19
    2009-03-16
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    Paclitaxel

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    USDMF

    Caution USDMF

    12757
    Inactive
    PACLITAXEL, DRUG SUBSTANCE
    1997-11-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-102 - Rev 03
    Valid
    Paclitaxel, produced by semi-synthe...
    2022-10-19
    Japanese DMF

    Found JDMF

    218MF10269
    Paclitaxel / PI at Viale Ortles 12 ...
    2006-05-22
    Written Confirmation

    Close WC

    Application Number
    12757
    R1-CEP 2008-102 - Rev 03
    218MF10269
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL, DRUG SUBSTANCE
    Paclitaxel, produced by semi-synthe...
    Paclitaxel / PI at Viale Ortles 12 ...
    Issue/Submission Date
    1997-11-20
    2022-10-19
    2006-05-22
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    Paclitaxel

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    USDMF

    Caution USDMF

    12876
    Inactive
    PACLITAXEL
    1998-02-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-346 - Rev 05
    Valid
    Paclitaxel, Produced by a semi-synt...
    2023-07-11
    Japanese DMF

    Found JDMF

    226MF10210
    Paclitaxel / S at Viale Ortles 12 M...
    2014-10-27
    Written Confirmation

    Close WC

    Application Number
    12876
    R0-CEP 2019-346 - Rev 05
    226MF10210
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL
    Paclitaxel, Produced by a semi-synt...
    Paclitaxel / S at Viale Ortles 12 M...
    Issue/Submission Date
    1998-02-23
    2023-07-11
    2014-10-27
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    Paclitaxel

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    USDMF

    Found USDMF

    20977
    Active
    PACLITAXEL/S
    2007-10-22
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-319 - Rev 00
    Withdrawn by Holder
    Paclitaxel, isolated from natural s...
    2013-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20977
    R1-CEP 2006-319 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PACLITAXEL/S
    Paclitaxel, isolated from natural s...
    Issue/Submission Date
    2007-10-22
    2013-03-26
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    • FDA
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    Paclitaxel

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    USDMF

    Found USDMF

    27162
    Active
    PACLITAXEL/S SEMISYNTHETIC PROCESS,...
    2013-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27162
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PACLITAXEL/S SEMISYNTHETIC PROCESS,...
    Issue/Submission Date
    2013-08-06
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    Paclitaxel

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    USDMF

    Found USDMF

    34200
    Active
    PACLITAXEL/SW
    2019-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34200
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PACLITAXEL/SW
    Issue/Submission Date
    2019-10-25
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