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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Henan Topfond Pharmaceutical Co,. Ltd

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    HENAN TOPFOND PHARMACEUTICAL Co,. Ltd

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    01 Lincomycin Hydrochloride (1)

    02 Lovastatin (1)

    03 Simvastatin (4)

    04 Spiramycin (1)

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    01 Active (5)

    02 Blank (2)

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    01 Valid (4)

    02 Withdrawn by Holder (1)

    03 Blank (2)

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    01 Blank (7)

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    Lincomycin Hydrochloride

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    USDMF

    Found USDMF

    37124
    Active
    LINCOMYCIN HYDROCHLORIDE
    2022-07-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-225 - Rev 02
    Valid
    Lincomycin hydrochloride
    2021-11-29
    Japanese DMF

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    Application Number
    37124
    R1-CEP 2008-225 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    LINCOMYCIN HYDROCHLORIDE
    Lincomycin hydrochloride
    Issue/Submission Date
    2022-07-28
    2021-11-29
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    Simvastatin

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    USDMF

    Found USDMF

    19545
    Active
    SIMVASTATIN, NON-STERILE BULK FORM
    2006-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-323 - Rev 01
    Valid
    Simvastatin, Antioxidant butylhydro...
    2019-11-06
    Japanese DMF

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    Application Number
    19545
    R1-CEP 2011-323 - Rev 01
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    SIMVASTATIN, NON-STERILE BULK FORM
    Simvastatin, Antioxidant butylhydro...
    Issue/Submission Date
    2006-04-20
    2019-11-06
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    Simvastatin

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    USDMF

    Found USDMF

    27882
    Active
    SIMVASTATIN AMMONIUM SALT(DRUG SUBS...
    2014-01-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-232 - Rev 04
    Valid
    Simvastatin
    2022-03-15
    Japanese DMF

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    Application Number
    27882
    R1-CEP 2006-232 - Rev 04
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    SIMVASTATIN AMMONIUM SALT(DRUG SUBS...
    Simvastatin
    Issue/Submission Date
    2014-01-24
    2022-03-15
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    Simvastatin

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    USDMF

    Found USDMF

    32786
    Active
    SIMVASTATIN AMMONIUM SALT (DRUG SUB...
    2018-01-19
    CEP/COS

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    Application Number
    32786
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SIMVASTATIN AMMONIUM SALT (DRUG SUB...
    Issue/Submission Date
    2018-01-19
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    Simvastatin

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    USDMF

    Found USDMF

    34089
    Active
    SIMVASTATIN (DRUG SUBSTANCE)
    2019-08-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34089
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SIMVASTATIN (DRUG SUBSTANCE)
    Issue/Submission Date
    2019-08-15
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    Spiramycin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2005-165 - Rev 05
    Valid
    Spiramycin
    2021-08-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2005-165 - Rev 05
    Status
    Valid
     
    Filing Details
    Spiramycin
    Issue/Submission Date
    2021-08-19
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    Lovastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-161 - Rev 02
    Withdrawn by Holder
    Lovastatin
    2011-11-08
    Japanese DMF

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    Application Number
    R0-CEP 2006-161 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Lovastatin
    Issue/Submission Date
    2011-11-08
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