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

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    01 Cilostazol (3)

    02 Hydroxychloroquine Sulphate (1)

    03 Sulfadiazine (1)

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    01 Active (3)

    02 Inactive (1)

    03 Blank (1)

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    01 Valid (2)

    02 Blank (3)

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    01 224MF10046 (1)

    02 229MF10106 (1)

    03 301MF10012 (1)

    04 305MF10077 (1)

    05 Blank (1)

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    01 Blank (5)

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    Hydroxychloroquine Sulphate

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    USDMF

    Found USDMF

    30825
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    2016-08-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-022 - Rev 00
    Valid
    Hydroxychloroquine sulfate
    2023-06-26
    Japanese DMF

    Found JDMF

    305MF10077
    Hydroxychloroquine Sulfate at No. 4...
    2023-07-05
    Written Confirmation

    Close WC

    Application Number
    30825
    R0-CEP 2022-022 - Rev 00
    305MF10077
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Hydroxychloroquine sulfate
    Hydroxychloroquine Sulfate at No. 4...
    Issue/Submission Date
    2016-08-01
    2023-06-26
    2023-07-05
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    • FDA
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    Cilostazol

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    USDMF

    Found USDMF

    22463
    Active
    CILOSTAZOL USP (DRUG SUBSTANCE, NON...
    2009-01-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10012
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    2019-05-31
    Written Confirmation

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    Application Number
    22463
    301MF10012
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    CILOSTAZOL USP (DRUG SUBSTANCE, NON...
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    Issue/Submission Date
    2009-01-16
    2019-05-31
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    Cilostazol

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    USDMF

    Found USDMF

    25666
    Active
    CILOSTAZOL USP
    2011-12-22
    CEP/COS

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    Japanese DMF

    Found JDMF

    224MF10046
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    2012-03-12
    Written Confirmation

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    Application Number
    25666
    224MF10046
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    CILOSTAZOL USP
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    Issue/Submission Date
    2011-12-22
    2012-03-12
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    Cilostazol

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    USDMF

    Caution USDMF

    22643
    Inactive
    CILOSTAZOL DRUG SUBSTANCE NON STERI...
    2008-12-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10106
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    2017-06-21
    Written Confirmation

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    Application Number
    22643
    229MF10106
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CILOSTAZOL DRUG SUBSTANCE NON STERI...
    Cilostazol at No. 4 HUAZHONG ROAD, ...
    Issue/Submission Date
    2008-12-25
    2017-06-21
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    Sulfadiazine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-042 - Rev 01
    Valid
    Sulfadiazine
    2023-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2019-042 - Rev 01
    Status
    Valid
     
    Filing Details
    Sulfadiazine
    Issue/Submission Date
    2023-01-09
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