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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd

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    Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd

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    01 Amantadine Hydrochloride (1)

    02 Dextromethorphan Hydrobromide (2)

    03 Ephedrine Hydrochloride (1)

    04 Ivermectin (1)

    05 Levofloxacin (1)

    06 Levofloxacin Hemihydrate (1)

    07 Lovastatin (1)

    08 Marbofloxacin (1)

    09 Memantine Hydrochloride (1)

    10 Ofloxacin (2)

    11 Pseudoephedrine Hydrochloride (1)

    12 Simvastatin (1)

    13 Tylosin Tartrate (1)

    14 Blank (1)

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    01 Active (6)

    02 Inactive (2)

    03 Blank (8)

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    01 Expired (2)

    02 Valid (5)

    03 Withdrawn by Holder (2)

    04 Blank (7)

    filter

    01 218MF10567 (1)

    02 223MF10070 (1)

    03 223MF10078 (1)

    04 225MF10070 (1)

    05 231MF10021 (1)

    06 Blank (11)

    filter

    01 Blank (16)

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    Amantadine Hydrochloride

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    USDMF

    Found USDMF

    25151
    Active
    AMANTADINE HYDROCHLORIDE USP
    2011-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10070
    Amantadine hydrochloride at 333, Ji...
    2011-05-27
    Written Confirmation

    Close WC

    Application Number
    25151
    223MF10070
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    AMANTADINE HYDROCHLORIDE USP
    Amantadine hydrochloride at 333, Ji...
    Issue/Submission Date
    2011-07-21
    2011-05-27
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    Dextromethorphan Hydrobromide

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    USDMF

    Found USDMF

    34902
    Active
    DEXTROMETHORPHAN HYDROBROMIDE
    2020-08-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-026 - Rev 00
    Valid
    Dextromethorphan hydrobromide
    2022-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34902
    R0-CEP 2021-026 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE
    Dextromethorphan hydrobromide
    Issue/Submission Date
    2020-08-26
    2022-01-05
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    Levofloxacin Hemihydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-128 - Rev 00
    Valid
    Levofloxacin hemihydrate
    2021-07-16
    Japanese DMF

    Found JDMF

    223MF10078
    Levofloxacin hydrate at 333, Jiangn...
    2011-06-07
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-128 - Rev 00
    223MF10078
    Status
    Valid
     
    Filing Details
    Levofloxacin hemihydrate
    Levofloxacin hydrate at 333, Jiangn...
    Issue/Submission Date
    2021-07-16
    2011-06-07
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    Ofloxacin

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2021-213 - Rev 01
    Valid
    Ofloxacin, Process H
    2023-10-06
    Japanese DMF

    Found JDMF

    225MF10070
    Ofloxacin at 333, Jiangnan Road, He...
    2013-04-18
    Written Confirmation

    Close WC

    Application Number
    CEP 2021-213 - Rev 01
    225MF10070
    Status
    Valid
     
    Filing Details
    Ofloxacin, Process H
    Ofloxacin at 333, Jiangnan Road, He...
    Issue/Submission Date
    2023-10-06
    2013-04-18
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    Ofloxacin

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-146 - Rev 02
    Withdrawn by Holder
    Ofloxacin
    2011-02-07
    Japanese DMF

    Found JDMF

    218MF10567
    Ofloxacin at 333, Jiangnan Road, He...
    2006-06-15
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-146 - Rev 02
    218MF10567
    Status
    Withdrawn by Holder
     
    Filing Details
    Ofloxacin
    Ofloxacin at 333, Jiangnan Road, He...
    Issue/Submission Date
    2011-02-07
    2006-06-15
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    Ephedrine Hydrochloride

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    USDMF

    Found USDMF

    18271
    Active
    PSEUDOEPHEDRINE HYDROCHLORIDE USP
    2005-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18271
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PSEUDOEPHEDRINE HYDROCHLORIDE USP
    Issue/Submission Date
    2005-03-31
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    Levofloxacin

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    USDMF

    Found USDMF

    19511
    Active
    LEVOFLOXACIN HEMIHYDRATE, USP
    2006-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19511
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LEVOFLOXACIN HEMIHYDRATE, USP
    Issue/Submission Date
    2006-06-06
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    Lovastatin

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    USDMF

    Found USDMF

    19217
    Active
    LOVASTATIN USP, NON-STERILE ACTIVE ...
    2006-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19217
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LOVASTATIN USP, NON-STERILE ACTIVE ...
    Issue/Submission Date
    2006-03-01
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    Marbofloxacin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-269 - Rev 00
    Valid
    Marbofloxacin for veterinary use
    2023-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-269 - Rev 00
    Status
    Valid
     
    Filing Details
    Marbofloxacin for veterinary use
    Issue/Submission Date
    2023-01-26
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    Memantine Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10021
    Memantine Hydrochloride at 333, Jia...
    2019-01-29
    Written Confirmation

    Close WC

    Application Number
    231MF10021
    Status
     
    Filing Details
    Memantine Hydrochloride at 333, Jia...
    Issue/Submission Date
    2019-01-29
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