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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Istituto Biochimico Italiano Giovanni Lorenzini Spa

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    Istituto Biochimico Italiano Giovanni Lorenzini SpA

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    01 Amoxicillin Sodium (1)

    02 Ampicillin Sodium (1)

    03 Cloxacillin Sodium (1)

    04 Flucloxacillin Sodium (1)

    05 Oxacillin Sodium (1)

    06 Piperacillin Sodium (3)

    07 Sulbactam Sodium (2)

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    01 Active (3)

    02 Inactive (1)

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    01 Valid (5)

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    Ampicillin Sodium

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    USDMF

    Found USDMF

    13742
    Active
    AMPICILLIN SODIUM STERILE CRYSTALLI...
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 1999-169 - Rev 07
    Valid
    Ampicillin sodium, Sterile
    2024-02-27
    Japanese DMF

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    Written Confirmation

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    Application Number
    13742
    CEP 1999-169 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMPICILLIN SODIUM STERILE CRYSTALLI...
    Ampicillin sodium, Sterile
    Issue/Submission Date
    1998-09-01
    2024-02-27
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    Amoxicillin Sodium

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 1996-013 - Rev 09
    Valid
    Amoxicillin sodium, Sterile
    2024-01-19
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    Application Number
    CEP 1996-013 - Rev 09
    Status
    Valid
     
    Filing Details
    Amoxicillin sodium, Sterile
    Issue/Submission Date
    2024-01-19
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    Flucloxacillin Sodium

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 1999-039 - Rev 07
    Valid
    Flucloxacillin sodium monohydrate, ...
    2024-01-17
    Japanese DMF

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    Application Number
    CEP 1999-039 - Rev 07
    Status
    Valid
     
    Filing Details
    Flucloxacillin sodium monohydrate, ...
    Issue/Submission Date
    2024-01-17
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    Oxacillin Sodium

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    USDMF

    Found USDMF

    13743
    Active
    OXACILLIN SODIUM STERILE CRYSTALLIN...
    1998-09-01
    CEP/COS

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    Japanese DMF

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    Application Number
    13743
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OXACILLIN SODIUM STERILE CRYSTALLIN...
    Issue/Submission Date
    1998-09-01
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    Piperacillin Sodium

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2006-252 - Rev 04
    Valid
    Piperacillin sodium, Sterile
    2024-01-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2006-252 - Rev 04
    Status
    Valid
     
    Filing Details
    Piperacillin sodium, Sterile
    Issue/Submission Date
    2024-01-19
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    Piperacillin Sodium

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 1999-117 - Rev 09
    Valid
    Piperacillin sodium, Sterile
    2024-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    CEP 1999-117 - Rev 09
    Status
    Valid
     
    Filing Details
    Piperacillin sodium, Sterile
    Issue/Submission Date
    2024-01-19
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    Sulbactam Sodium

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    USDMF

    Found USDMF

    34192
    Active
    SULBACTAM SODIUM STERILE USP
    2020-05-29
    CEP/COS

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    Japanese DMF

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    Application Number
    34192
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SULBACTAM SODIUM STERILE USP
    Issue/Submission Date
    2020-05-29
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    Cloxacillin Sodium

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-241 - Rev 01
    Withdrawn by Holder
    Cloxacillin sodium, Sterile, Crysta...
    2009-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2001-241 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Cloxacillin sodium, Sterile, Crysta...
    Issue/Submission Date
    2009-10-16
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    Piperacillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-116 - Rev 05
    Withdrawn by Holder
    Piperacillin monohydrate
    2015-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 1999-116 - Rev 05
    Status
    Withdrawn by Holder
     
    Filing Details
    Piperacillin monohydrate
    Issue/Submission Date
    2015-02-03
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    Sulbactam Sodium

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    USDMF

    Caution USDMF

    17189
    Inactive
    SULBACTAM SODIUM STERILE
    2004-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    17189
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SULBACTAM SODIUM STERILE
    Issue/Submission Date
    2004-03-09
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