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

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    01 Atorvastatin (3)

    02 Clopidogrel (1)

    03 Efavirenz (1)

    04 Levetiracetam (2)

    05 Rosuvastatin Calcium (3)

    06 Simvastatin (6)

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    01 Active (3)

    02 Inactive (4)

    03 Blank (9)

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    01 Valid (13)

    02 Withdrawn by Holder (2)

    03 Blank (1)

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    01 228MF10102 (1)

    02 303MF10026 (1)

    03 Blank (14)

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    01 Blank (16)

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    Levetiracetam

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    USDMF

    Caution USDMF

    34222
    Inactive
    LEVETIRACETAM
    2019-12-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-031 - Rev 00
    Valid
    Levetiracetam, Site 2
    2023-03-17
    Japanese DMF

    Found JDMF

    303MF10026
    Levetiracetam at Dongdai Village, Z...
    2021-02-05
    Written Confirmation

    Close WC

    Application Number
    34222
    R0-CEP 2023-031 - Rev 00
    303MF10026
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LEVETIRACETAM
    Levetiracetam, Site 2
    Levetiracetam at Dongdai Village, Z...
    Issue/Submission Date
    2019-12-10
    2023-03-17
    2021-02-05
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    Simvastatin

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    USDMF

    Caution USDMF

    24935
    Inactive
    SIMVASTATIN AMMONIUM SALT
    2011-05-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-255 - Rev 03
    Valid
    Simvastatin
    2018-11-27
    Japanese DMF

    Found JDMF

    228MF10102
    Simvastatin at Dongdai Village, Zha...
    2016-05-27
    Written Confirmation

    Close WC

    Application Number
    24935
    R1-CEP 2005-255 - Rev 03
    228MF10102
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SIMVASTATIN AMMONIUM SALT
    Simvastatin
    Simvastatin at Dongdai Village, Zha...
    Issue/Submission Date
    2011-05-10
    2018-11-27
    2016-05-27
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    Atorvastatin

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    USDMF

    Found USDMF

    31764
    Active
    ATORVASTATIN CALCIUM
    2017-04-18
    CEP/COS

    Found CEP/COS

    CEP 2014-160 - Rev 02
    Valid
    Atorvastatin calcium
    2024-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    31764
    CEP 2014-160 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium
    Issue/Submission Date
    2017-04-18
    2024-02-12
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    Simvastatin

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    USDMF

    Found USDMF

    26971
    Active
    SIMVASTATIN
    2013-03-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-245 - Rev 00
    Valid
    Simvastatin
    2023-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26971
    R0-CEP 2022-245 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SIMVASTATIN
    Simvastatin
    Issue/Submission Date
    2013-03-04
    2023-05-17
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    Simvastatin

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    USDMF

    Found USDMF

    28583
    Active
    SIMVASTATIN (WITH 0.01% BHA)
    2014-08-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-266 - Rev 00
    Valid
    Simvastatin, With butylated hydroxy...
    2023-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    28583
    R0-CEP 2022-266 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SIMVASTATIN (WITH 0.01% BHA)
    Simvastatin, With butylated hydroxy...
    Issue/Submission Date
    2014-08-18
    2023-06-16
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    Simvastatin

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    USDMF

    Caution USDMF

    26088
    Inactive
    SIMVASTATIN AMMONIUM SALT (ALTERNAT...
    2012-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-025 - Rev 03
    Valid
    Simvastatin, Antioxidant butylated ...
    2019-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26088
    R1-CEP 2013-025 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SIMVASTATIN AMMONIUM SALT (ALTERNAT...
    Simvastatin, Antioxidant butylated ...
    Issue/Submission Date
    2012-05-16
    2019-07-17
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2023-160 - Rev 00
    Valid
    Atorvastatin calcium, Site 2
    2023-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2023-160 - Rev 00
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, Site 2
    Issue/Submission Date
    2023-08-17
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-383 - Rev 01
    Valid
    Atorvastatin calcium, IM2 process
    2023-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-383 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, IM2 process
    Issue/Submission Date
    2023-08-31
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    Levetiracetam

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-084 - Rev 03
    Valid
    Levetiracetam
    2020-09-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-084 - Rev 03
    Status
    Valid
     
    Filing Details
    Levetiracetam
    Issue/Submission Date
    2020-09-01
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    Rosuvastatin Calcium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-346 - Rev 00
    Valid
    Rosuvastatin calcium
    2023-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-346 - Rev 00
    Status
    Valid
     
    Filing Details
    Rosuvastatin calcium
    Issue/Submission Date
    2023-01-20
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