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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by China Resources Zizhu Pharmaceutical

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    01 CAS 53-16-7 (1)

    02 Desogestrel (1)

    03 Dienogest (1)

    04 Estriol (1)

    05 Ethinyl Estradiol (1)

    06 Gestodene (1)

    07 Heparin Sodium (1)

    08 Levonorgestrel (3)

    09 Mifepristone (1)

    10 Sulfamethoxazole (1)

    11 Testosterone (1)

    12 Tibolone (1)

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    01 Active (7)

    02 Blank (7)

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    01 Valid (8)

    02 Withdrawn by Holder (1)

    03 Blank (5)

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    01 231MF10019 (1)

    02 Blank (13)

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    01 Blank (14)

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    Gestodene

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    USDMF

    Found USDMF

    29345
    Active
    GESTODENE (MICRONIZED)
    2015-06-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-160 - Rev 00
    Valid
    Gestodene, Micronised
    2022-01-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    29345
    R1-CEP 2015-160 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    GESTODENE (MICRONIZED)
    Gestodene, Micronised
    Issue/Submission Date
    2015-06-08
    2022-01-19
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    Heparin Sodium

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    USDMF

    Found USDMF

    22222
    Active
    HEPARIN SODIUM USP
    2008-11-24
    CEP/COS

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    Japanese DMF

    Found JDMF

    231MF10019
    Heparin Sodium at No. 97,Zhuzhou Ro...
    2019-01-29
    Written Confirmation

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    Application Number
    22222
    231MF10019
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HEPARIN SODIUM USP
    Heparin Sodium at No. 97,Zhuzhou Ro...
    Issue/Submission Date
    2008-11-24
    2019-01-29
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    Levonorgestrel

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    USDMF

    Found USDMF

    27692
    Active
    LEVONORGESTREL (MICRONIZED)
    2013-10-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-237 - Rev 00
    Valid
    Levonorgestrel, Micronised
    2019-04-30
    Japanese DMF

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    Application Number
    27692
    R1-CEP 2013-237 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    LEVONORGESTREL (MICRONIZED)
    Levonorgestrel, Micronised
    Issue/Submission Date
    2013-10-20
    2019-04-30
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    Tibolone

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    USDMF

    Found USDMF

    29217
    Active
    TIBOLONE
    2015-03-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-015 - Rev 00
    Valid
    Tibolone
    2021-02-11
    Japanese DMF

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    Application Number
    29217
    R1-CEP 2015-015 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    TIBOLONE
    Tibolone
    Issue/Submission Date
    2015-03-26
    2021-02-11
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    CAS 53-16-7

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    USDMF

    Found USDMF

    28304
    Active
    ESTRONE
    2014-05-13
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28304
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ESTRONE
    Issue/Submission Date
    2014-05-13
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    Desogestrel

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-219 - Rev 00
    Valid
    Desogestrel
    2021-09-08
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2015-219 - Rev 00
    Status
    Valid
     
    Filing Details
    Desogestrel
    Issue/Submission Date
    2021-09-08
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    Dienogest

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    USDMF

    Found USDMF

    28680
    Active
    DIENOGEST (MICRONIZED)
    2014-09-25
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28680
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DIENOGEST (MICRONIZED)
    Issue/Submission Date
    2014-09-25
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    Estriol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-014 - Rev 00
    Valid
    Estriol, Micronised
    2021-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2015-014 - Rev 00
    Status
    Valid
     
    Filing Details
    Estriol, Micronised
    Issue/Submission Date
    2021-02-11
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    Ethinyl Estradiol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-220 - Rev 01
    Valid
    Ethinylestradiol, Micronised, non-m...
    2020-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2011-220 - Rev 01
    Status
    Valid
     
    Filing Details
    Ethinylestradiol, Micronised, non-m...
    Issue/Submission Date
    2020-08-25
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    Levonorgestrel

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2022-225 - Rev 00
    Valid
    Levonorgestrel, Micronised, Process...
    2022-12-20
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2022-225 - Rev 00
    Status
    Valid
     
    Filing Details
    Levonorgestrel, Micronised, Process...
    Issue/Submission Date
    2022-12-20
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