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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hanmi Pharmaceutical

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    01 Amlodipine Camsylate (1)

    02 Bepotastine (1)

    03 Cefdinir (1)

    04 Cefixime (1)

    05 Cefotaxime (2)

    06 Cefotiam Hydrochloride (1)

    07 Cefpodoxime Proxetil (1)

    08 Ceftazidime (2)

    09 Ceftriaxone (2)

    10 Clarithromycin (1)

    11 Duloxetine (1)

    12 Ezetimibe (1)

    13 Febuxostat (2)

    14 Irbesartan (1)

    15 Itraconazole (1)

    16 Linagliptin (1)

    17 Losartan Potassium (1)

    18 Pioglitazone Hydrochloride (1)

    19 Raloxifene Hydrochloride (1)

    20 Rosuvastatin Calcium (1)

    21 Blank (2)

    filter

    01 Active (1)

    02 Inactive (3)

    03 Blank (22)

    filter

    01 Valid (5)

    02 Withdrawn by Holder (3)

    03 Blank (18)

    filter

    01 217MF10415 (1)

    02 218MF10515 (1)

    03 219MF10006 (1)

    04 219MF10007 (1)

    05 219MF10097 (1)

    06 219MF10173 (1)

    07 222MF10023 (1)

    08 222MF10208 (1)

    09 222MF10273 (1)

    10 224MF10209 (1)

    11 225MF10225 (1)

    12 227MF10053 (1)

    13 228MF10121 (1)

    14 229MF10032 (1)

    15 230MF10059 (1)

    16 231MF10020 (1)

    17 301MF10085 (1)

    18 303MF10010 (1)

    19 305MF10121 (1)

    20 305MF10132 (1)

    21 Blank (6)

    filter

    01 Blank (26)

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    Cefotaxime

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    12632
    Inactive
    CEFOTAXIME ACID
    1997-08-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-161 - Rev 05
    Valid
    Cefotaxime sodium, Sterile; process...
    2019-07-02
    Japanese DMF

    Found JDMF

    224MF10209
    Sterile cefotaxime sodium at 57, Gy...
    2012-10-29
    Written Confirmation

    Close WC

    Application Number
    12632
    R1-CEP 1999-161 - Rev 05
    224MF10209
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CEFOTAXIME ACID
    Cefotaxime sodium, Sterile; process...
    Sterile cefotaxime sodium at 57, Gy...
    Issue/Submission Date
    1997-08-27
    2019-07-02
    2012-10-29
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    Ceftriaxone

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    USDMF

    Caution USDMF

    17884
    Inactive
    CEFTRIAXONE SODIUM, USP
    2004-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-158 - Rev 05
    Valid
    Ceftriaxone sodium, Sterile; synthe...
    2019-07-02
    Japanese DMF

    Found JDMF

    219MF10097
    Ceftriaxone sodium hydrate at 57, G...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    17884
    R1-CEP 2000-158 - Rev 05
    219MF10097
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CEFTRIAXONE SODIUM, USP
    Ceftriaxone sodium, Sterile; synthe...
    Ceftriaxone sodium hydrate at 57, G...
    Issue/Submission Date
    2004-12-04
    2019-07-02
    2007-03-14
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    Cefixime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-155 - Rev 06
    Valid
    Cefixime
    2019-07-02
    Japanese DMF

    Found JDMF

    217MF10415
    Cefixime at 57, Gyeongje-ro, Siheun...
    2005-08-19
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-155 - Rev 06
    217MF10415
    Status
    Valid
     
    Filing Details
    Cefixime
    Cefixime at 57, Gyeongje-ro, Siheun...
    Issue/Submission Date
    2019-07-02
    2005-08-19
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    Ceftazidime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-096 - Rev 04
    Valid
    Ceftazidime pentahydrate with sodiu...
    2023-05-25
    Japanese DMF

    Found JDMF

    219MF10007
    Ceftazidime hydrate at 57, Gyeongje...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-096 - Rev 04
    219MF10007
    Status
    Valid
     
    Filing Details
    Ceftazidime pentahydrate with sodiu...
    Ceftazidime hydrate at 57, Gyeongje...
    Issue/Submission Date
    2023-05-25
    2007-01-18
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    Ceftazidime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-069 - Rev 07
    Valid
    Ceftazidime Pentahydrate, Sterile
    2023-06-14
    Japanese DMF

    Found JDMF

    225MF10225
    Sterile ceftazidime hydrate at 57, ...
    2013-12-10
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-069 - Rev 07
    225MF10225
    Status
    Valid
     
    Filing Details
    Ceftazidime Pentahydrate, Sterile
    Sterile ceftazidime hydrate at 57, ...
    Issue/Submission Date
    2023-06-14
    2013-12-10
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    Bepotastine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10032
    Bepotastine besilate at 57, Gyeongj...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    229MF10032
    Status
     
    Filing Details
    Bepotastine besilate at 57, Gyeongj...
    Issue/Submission Date
    2017-02-08
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    Cefdinir

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10515
    Cefdinir at 57, Gyeongje-ro, Siheun...
    2006-05-18
    Written Confirmation

    Close WC

    Application Number
    218MF10515
    Status
     
    Filing Details
    Cefdinir at 57, Gyeongje-ro, Siheun...
    Issue/Submission Date
    2006-05-18
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    Cefotiam Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10006
    Cefotiam hydrochloride at 57, Gyeon...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    219MF10006
    Status
     
    Filing Details
    Cefotiam hydrochloride at 57, Gyeon...
    Issue/Submission Date
    2007-01-18
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    Clarithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10173
    Clarithromycin F at 57, Gyeongje-ro...
    2007-06-01
    Written Confirmation

    Close WC

    Application Number
    219MF10173
    Status
     
    Filing Details
    Clarithromycin F at 57, Gyeongje-ro...
    Issue/Submission Date
    2007-06-01
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    Duloxetine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10085
    Duloxetine Hydrochloride at 57, Gye...
    2019-10-25
    Written Confirmation

    Close WC

    Application Number
    301MF10085
    Status
     
    Filing Details
    Duloxetine Hydrochloride at 57, Gye...
    Issue/Submission Date
    2019-10-25
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