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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhuhai United Laboratories Co ., Ltd.

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    01 Amoxicillin Sodium (1)

    02 Amoxicillin Trihydrate (3)

    03 Ampicillin Sodium (1)

    04 Ampicillin Trihydrate (1)

    05 Cefoperazone Sodium (1)

    06 Cefotaxime (1)

    07 Ceftriaxone (1)

    08 Cefuroxime Sodium (1)

    09 Cilastatin Sodium (1)

    10 Clavulanic Acid (4)

    11 Imipenem (1)

    12 Meropenem (2)

    13 Sulbactam Sodium (1)

    filter

    01 Active (1)

    02 Inactive (12)

    03 Blank (6)

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    01 Valid (8)

    02 Withdrawn by Holder (2)

    03 Blank (9)

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    01 229MF10091 (1)

    02 230MF10038 (1)

    03 301MF10053 (1)

    04 Blank (16)

    filter

    01 Blank (19)

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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    22857
    Active
    AMPICILLIN TRIHYDRATE
    2009-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-090 - Rev 03
    Valid
    Ampicillin trihydrate, Compacted, p...
    2021-07-13
    Japanese DMF

    Found JDMF

    230MF10038
    Ampicillin Trihydrate at No. 2428, ...
    2018-02-28
    Written Confirmation

    Close WC

    Application Number
    22857
    R1-CEP 2010-090 - Rev 03
    230MF10038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Ampicillin trihydrate, Compacted, p...
    Ampicillin Trihydrate at No. 2428, ...
    Issue/Submission Date
    2009-06-10
    2021-07-13
    2018-02-28
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    15377
    Inactive
    AMOXICILLIN USP BULK SUBSTANCE
    2001-04-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-191 - Rev 03
    Valid
    Amoxicillin trihydrate, Compacted
    2019-02-06
    Japanese DMF

    Found JDMF

    229MF10091
    Amoxicillin Trihydrate at No. 2428,...
    2017-05-01
    Written Confirmation

    Close WC

    Application Number
    15377
    R1-CEP 2007-191 - Rev 03
    229MF10091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN USP BULK SUBSTANCE
    Amoxicillin trihydrate, Compacted
    Amoxicillin Trihydrate at No. 2428,...
    Issue/Submission Date
    2001-04-06
    2019-02-06
    2017-05-01
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    USDMF

    Caution USDMF

    20517
    Inactive
    AMOXICILLIN TRIHYDRATE USP
    2007-05-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-039 - Rev 02
    Valid
    Amoxicillin trihydrate, Micronised,...
    2020-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20517
    R1-CEP 2006-039 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE USP
    Amoxicillin trihydrate, Micronised,...
    Issue/Submission Date
    2007-05-09
    2020-10-16
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    Clavulanic Acid

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    USDMF

    Caution USDMF

    26111
    Inactive
    POTASSIUM CLAVULANATE - MICROCRYSTA...
    2012-05-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-083 - Rev 00
    Valid
    Potassium clavulanate
    2021-11-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26111
    R1-CEP 2015-083 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE - MICROCRYSTA...
    Potassium clavulanate
    Issue/Submission Date
    2012-05-29
    2021-11-26
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    Clavulanic Acid

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    USDMF

    Caution USDMF

    28638
    Inactive
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2014-09-15
    CEP/COS

    Found CEP/COS

    CEP 2013-133 - Rev 02
    Valid
    Potassium clavulanate, Sterile
    2024-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28638
    CEP 2013-133 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, Sterile
    Issue/Submission Date
    2014-09-15
    2024-03-04
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    Amoxicillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-125 - Rev 03
    Valid
    Amoxicillin sodium, Sterile
    2023-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-125 - Rev 03
    Status
    Valid
     
    Filing Details
    Amoxicillin sodium, Sterile
    Issue/Submission Date
    2023-03-15
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    Ampicillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10053
    Ampicillin Sodium at No. 2428, Anji...
    2019-08-28
    Written Confirmation

    Close WC

    Application Number
    301MF10053
    Status
     
    Filing Details
    Ampicillin Sodium at No. 2428, Anji...
    Issue/Submission Date
    2019-08-28
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    Clavulanic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-163 - Rev 00
    Valid
    Potassium clavulanate, diluted, Wit...
    2019-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-163 - Rev 00
    Status
    Valid
     
    Filing Details
    Potassium clavulanate, diluted, Wit...
    Issue/Submission Date
    2019-11-12
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    Clavulanic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-187 - Rev 00
    Valid
    Potassium clavulanate, diluted, Wit...
    2019-11-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-187 - Rev 00
    Status
    Valid
     
    Filing Details
    Potassium clavulanate, diluted, Wit...
    Issue/Submission Date
    2019-11-13
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    21197
    Inactive
    AMOXICILLIN (COMPACTED)
    2008-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21197
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AMOXICILLIN (COMPACTED)
    Issue/Submission Date
    2008-01-04
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