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

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    01 Clindamycin Hydrochloride (1)

    02 Clindamycin Phosphate (1)

    03 Lincomycin Hydrochloride (2)

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    01 Active (3)

    02 Blank (1)

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    01 Valid (4)

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    01 231MF10034 (1)

    02 Blank (3)

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    Lincomycin Hydrochloride

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    USDMF

    Found USDMF

    19056
    Active
    LINCOMYCIN HYDROCHLORIDE USP
    2005-12-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-168 - Rev 00
    Valid
    Lincomycin hydrochloride
    2023-07-17
    Japanese DMF

    Found JDMF

    231MF10034
    Japanese Pharmacopoeia Lincomycin H...
    2019-02-12
    Written Confirmation

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    Application Number
    19056
    R1-CEP 2017-168 - Rev 00
    231MF10034
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    LINCOMYCIN HYDROCHLORIDE USP
    Lincomycin hydrochloride
    Japanese Pharmacopoeia Lincomycin H...
    Issue/Submission Date
    2005-12-08
    2023-07-17
    2019-02-12
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    Clindamycin Hydrochloride

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    USDMF

    Found USDMF

    32342
    Active
    CLINDAMYCIN HYDROCHLORIDE USP (NON-...
    2018-01-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-223 - Rev 00
    Valid
    Clindamycin hydrochloride
    2023-08-21
    Japanese DMF

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    Written Confirmation

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    Application Number
    32342
    R0-CEP 2022-223 - Rev 00
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    CLINDAMYCIN HYDROCHLORIDE USP (NON-...
    Clindamycin hydrochloride
    Issue/Submission Date
    2018-01-08
    2023-08-21
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    Clindamycin Phosphate

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    USDMF

    Found USDMF

    24358
    Active
    CLINDAMYCIN PHOSPHATE USP
    2010-11-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-019 - Rev 01
    Valid
    Clindamycin phosphate
    2018-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    24358
    R1-CEP 2011-019 - Rev 01
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CLINDAMYCIN PHOSPHATE USP
    Clindamycin phosphate
    Issue/Submission Date
    2010-11-08
    2018-06-13
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    Lincomycin Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2020-105 - Rev 01
    Valid
    Lincomycin hydrochloride, Alternati...
    2024-02-28
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2020-105 - Rev 01
    Status
    Valid
     
    Filing Details
    Lincomycin hydrochloride, Alternati...
    Issue/Submission Date
    2024-02-28
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