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    China Sinopharm International Corp.
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    China
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    4, Huixindongjie, Chaoyang District, Beijing 100029
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    +86 846 631 00
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    32811
    Active
    AMOXICILLIN TRIHYDRATE, USP
    2018-05-15
    CEP/COS

    Found CEP/COS

    CEP 2019-244 - Rev 02
    Valid
    Amoxicillin trihydrate
    2023-12-18
    Japanese DMF

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    Application Number
    32811
    CEP 2019-244 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE, USP
    Amoxicillin trihydrate
    Issue/Submission Date
    2018-05-15
    2023-12-18
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    36579
    Active
    AMOXICILLIN TRIHYDRATE (POWDER)
    2021-12-23
    CEP/COS

    Found CEP/COS

    CEP 2021-461 - Rev 01
    Valid
    Amoxicillin trihydrate, Compacted
    2023-12-20
    Japanese DMF

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    Application Number
    36579
    CEP 2021-461 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE (POWDER)
    Amoxicillin trihydrate, Compacted
    Issue/Submission Date
    2021-12-23
    2023-12-20
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    Clavulanic Acid

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    USDMF

    Found USDMF

    27903
    Active
    CLAVULANATE POTASSIUM, USP
    2014-02-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-329 - Rev 00
    Valid
    Potassium clavulanate, diluted, wit...
    2021-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    27903
    R1-CEP 2014-329 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM, USP
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2014-02-05
    2021-03-03
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    Clavulanic Acid

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    USDMF

    Found USDMF

    27966
    Active
    CLAVULANATE POTASSIUM DILUTED 1:1 W...
    2014-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-320 - Rev 00
    Valid
    Potassium clavulanate
    2021-03-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    27966
    R1-CEP 2014-320 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM DILUTED 1:1 W...
    Potassium clavulanate
    Issue/Submission Date
    2014-03-12
    2021-03-05
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    6-Aminopenicillanic Acid

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    USDMF

    Found USDMF

    30779
    Active
    6-AMINOPENICILLANIC ACID
    2016-08-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    30779
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    6-AMINOPENICILLANIC ACID
    Issue/Submission Date
    2016-08-02
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    7-Amino Cephalosporanic Acid

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    USDMF

    Found USDMF

    30473
    Active
    7-AMINOCEPHALOSPORANIC ACID
    2016-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

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    Application Number
    30473
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    7-AMINOCEPHALOSPORANIC ACID
    Issue/Submission Date
    2016-05-09
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    Abacavir Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-198 - Rev 00
    Valid
    Abacavir sulfate
    2022-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2020-198 - Rev 00
    Status
    Valid
     
    Filing Details
    Abacavir sulfate
    Issue/Submission Date
    2022-07-12
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    Alpha Lipoic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-119 - Rev 01
    Valid
    Thioctic acid
    2019-10-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2008-119 - Rev 01
    Status
    Valid
     
    Filing Details
    Thioctic acid
    Issue/Submission Date
    2019-10-03
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    36698
    Active
    AMOXICILLIN TRIHYDRATE (COMPACTED P...
    2022-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    36698
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMOXICILLIN TRIHYDRATE (COMPACTED P...
    Issue/Submission Date
    2022-02-13
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    38056
    Active
    AMPICILLIN TRIHYDRATE (POWDER)
    2023-03-30
    CEP/COS

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    Japanese DMF

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    Application Number
    38056
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPICILLIN TRIHYDRATE (POWDER)
    Issue/Submission Date
    2023-03-30
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      Azithromycin Dihydrate

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      USDMF

      Found USDMF

      30887
      Active
      AZITHROMYCIN DIHYDRATE
      2016-12-29
      CEP/COS

      Close CEP/COS

      Japanese DMF

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      Written Confirmation

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      Application Number
      30887
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      AZITHROMYCIN DIHYDRATE
      Issue/Submission Date
      2016-12-29
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      Azithromycin Dihydrate

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2016-070 - Rev 00
      Valid
      Azithromycin, Dihydrate
      2022-11-09
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      R1-CEP 2016-070 - Rev 00
      Status
      Valid
       
      Filing Details
      Azithromycin, Dihydrate
      Issue/Submission Date
      2022-11-09
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      Cefpirome Sulphate

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      USDMF

      Close USDMF

      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      220MF10013
      Cefpirome sulfate at Rich Economy D...
      2008-01-09
      Written Confirmation

      Close WC

      Application Number
      220MF10013
      Status
       
      Filing Details
      Cefpirome sulfate at Rich Economy D...
      Issue/Submission Date
      2008-01-09
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      Ceftriaxone

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      USDMF

      Found USDMF

      32857
      Active
      DEACYL CEFTRIAXONE (7-ACT)
      2018-06-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      32857
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      DEACYL CEFTRIAXONE (7-ACT)
      Issue/Submission Date
      2018-06-12
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      Ceftriaxone

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      USDMF

      Found USDMF

      33501
      Active
      CEFTRIAXONE SODIUM (NON-STERILE BUL...
      2019-02-28
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      33501
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      CEFTRIAXONE SODIUM (NON-STERILE BUL...
      Issue/Submission Date
      2019-02-28
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      Cefuroxime Axetil

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      USDMF

      Found USDMF

      36198
      Active
      CEFUROXIME AXETIL
      2021-08-17
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      36198
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      CEFUROXIME AXETIL
      Issue/Submission Date
      2021-08-17
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      Clavulanic Acid

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2014-327 - Rev 00
      Valid
      Potassium clavulanate, diluted, wit...
      2021-03-05
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2014-327 - Rev 00
      Status
      Valid
       
      Filing Details
      Potassium clavulanate, diluted, wit...
      Issue/Submission Date
      2021-03-05
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      Deacetyl-7-Aminocephalosporanic Acid

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      USDMF

      Found USDMF

      31495
      Active
      DEACETYL-7-AMINOCEPHALOSPORANIC ACI...
      2017-03-08
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      31495
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      DEACETYL-7-AMINOCEPHALOSPORANIC ACI...
      Issue/Submission Date
      2017-03-08
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      Nebivolol

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      CEP 2022-069 - Rev 00
      Valid
      Nebivolol hydrochloride
      2024-04-25
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      CEP 2022-069 - Rev 00
      Status
      Valid
       
      Filing Details
      Nebivolol hydrochloride
      Issue/Submission Date
      2024-04-25
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      Potassium

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      USDMF

      Found USDMF

      27976
      Active
      CLAVULANATE POTASSIUM DILUTED 1:1 W...
      2014-03-18
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      27976
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      CLAVULANATE POTASSIUM DILUTED 1:1 W...
      Issue/Submission Date
      2014-03-18
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        Ritalinic Acid

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        USDMF

        Found USDMF

        21342
        Active
        RITALINIC ACID
        2008-02-15
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        21342
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        RITALINIC ACID
        Issue/Submission Date
        2008-02-15
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          Zidovudine

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          USDMF

          Found USDMF

          27207
          Active
          ZIDOVUDINE
          2013-06-10
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          27207
          Status
          Active
          Fees Paid
          Reviewed
           
          Filing Details
          ZIDOVUDINE
          Issue/Submission Date
          2013-06-10
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            Caspofungin

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            USDMF

            Caution USDMF

            29682
            Inactive
            CASPOFUNGIN ACETATE
            2015-11-12
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            29682
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            CASPOFUNGIN ACETATE
            Issue/Submission Date
            2015-11-12
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            Ceftriaxone

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            USDMF

            Caution USDMF

            33015
            Inactive
            CEFTRIAXONE SODIUM, USP
            2018-08-01
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            33015
            Status
            Inactive
            Fees Paid
            N/A
             
            Filing Details
            CEFTRIAXONE SODIUM, USP
            Issue/Submission Date
            2018-08-01
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              Human Chorionic Gonadotropin

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              USDMF

              Caution USDMF

              9356
              Inactive
              HUMAN CHORIONIC GONADOTROPIN
              1991-10-01
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              9356
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              HUMAN CHORIONIC GONADOTROPIN
              Issue/Submission Date
              1991-10-01
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                Hydroxy Echinocandin

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                USDMF

                Caution USDMF

                29552
                Inactive
                PNEUMOCANDIN M1
                2015-08-31
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                29552
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                PNEUMOCANDIN M1
                Issue/Submission Date
                2015-08-31
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                  Hydroxy Echinocandin

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                  USDMF

                  Caution USDMF

                  29681
                  Inactive
                  PNEUMOCANDIN B0
                  2015-10-30
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  29681
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  PNEUMOCANDIN B0
                  Issue/Submission Date
                  2015-10-30
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                    Menotropins

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                    USDMF

                    Caution USDMF

                    8729
                    Inactive
                    MENOTROPINS
                    1990-09-12
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    8729
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    MENOTROPINS
                    Issue/Submission Date
                    1990-09-12
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                      Micafungin

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                      USDMF

                      Caution USDMF

                      29662
                      Inactive
                      MICAFUNGIN SODIUM
                      2015-09-29
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      29662
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      MICAFUNGIN SODIUM
                      Issue/Submission Date
                      2015-09-29
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                        Ritalinic Acid

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                        USDMF

                        Caution USDMF

                        19564
                        Inactive
                        RITALINIC ACID
                        2006-06-23
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        19564
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
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                          1991-08-27
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