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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shandong Anxin Pharmaceutical

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    Shandong Anxin Pharmaceutical

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    01 Amikacin Sulfate (1)

    02 Capecitabine (1)

    03 Celecoxib (1)

    04 Hydroxyurea (1)

    05 Imatinib Mesylate (2)

    06 Olmesartan Medoxomil (1)

    07 Piperacillin Sodium (1)

    08 Quetiapine Hemifumarate (1)

    09 Tadalafil (1)

    10 Tazobactam Sodium (1)

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    01 Active (1)

    02 Blank (10)

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    01 Expired (1)

    02 Valid (9)

    03 Blank (1)

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    01 Blank (11)

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    01 Blank (11)

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      Amikacin Sulfate

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2010-308 - Rev 01
      Valid
      Amikacin sulfate
      2020-01-16
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      Application Number
      R1-CEP 2010-308 - Rev 01
      Status
      Valid
       
      Filing Details
      Amikacin sulfate
      Issue/Submission Date
      2020-01-16
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        Capecitabine

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        CEP/COS

        Found CEP/COS

        CEP 2014-189 - Rev 03
        Valid
        Capecitabine
        2024-02-19
        Japanese DMF

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        Application Number
        CEP 2014-189 - Rev 03
        Status
        Valid
         
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        Capecitabine
        Issue/Submission Date
        2024-02-19
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          Celecoxib

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          CEP/COS

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          R1-CEP 2015-297 - Rev 01
          Valid
          Celecoxib
          2022-08-26
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          Application Number
          R1-CEP 2015-297 - Rev 01
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          Celecoxib
          Issue/Submission Date
          2022-08-26
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            Hydroxyurea

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            CEP/COS

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            R1-CEP 2005-051 - Rev 04
            Valid
            Hydroxycarbamide
            2021-09-24
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            Application Number
            R1-CEP 2005-051 - Rev 04
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            Hydroxycarbamide
            Issue/Submission Date
            2021-09-24
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              Imatinib Mesylate

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              CEP/COS

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              R1-CEP 2016-039 - Rev 00
              Valid
              Imatinib mesilate
              2022-06-01
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              Application Number
              R1-CEP 2016-039 - Rev 00
              Status
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              Imatinib mesilate
              Issue/Submission Date
              2022-06-01
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                CEP/COS

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                R0-CEP 2017-292 - Rev 02
                Valid
                Imatinib mesilate, β form
                2022-06-27
                Japanese DMF

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                Application Number
                R0-CEP 2017-292 - Rev 02
                Status
                Valid
                 
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                Imatinib mesilate, β form
                Issue/Submission Date
                2022-06-27
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                  Olmesartan Medoxomil

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                  CEP/COS

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                  R1-CEP 2014-225 - Rev 00
                  Valid
                  Olmesartan medoxomil
                  2022-01-05
                  Japanese DMF

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                  Application Number
                  R1-CEP 2014-225 - Rev 00
                  Status
                  Valid
                   
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                  Olmesartan medoxomil
                  Issue/Submission Date
                  2022-01-05
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                    Piperacillin Sodium

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                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2015-389 - Rev 00
                    Valid
                    Piperacillin monohydrate
                    2022-04-22
                    Japanese DMF

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                    Application Number
                    R1-CEP 2015-389 - Rev 00
                    Status
                    Valid
                     
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                    Piperacillin monohydrate
                    Issue/Submission Date
                    2022-04-22
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                      Tadalafil

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                      USDMF

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                      CEP/COS

                      Found CEP/COS

                      R1-CEP 2016-001 - Rev 00
                      Valid
                      Tadalafil
                      2022-02-02
                      Japanese DMF

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                      Application Number
                      R1-CEP 2016-001 - Rev 00
                      Status
                      Valid
                       
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                      Tadalafil
                      Issue/Submission Date
                      2022-02-02
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                        Tazobactam Sodium

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                        USDMF

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                        36268
                        Active
                        TAZOBACTAM (TRIAZOLE PROCESS)
                        2022-05-23
                        CEP/COS

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                        Japanese DMF

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                        Application Number
                        36268
                        Status
                        Active
                        Fees Unpaid
                        Reviewed
                         
                        Filing Details
                        TAZOBACTAM (TRIAZOLE PROCESS)
                        Issue/Submission Date
                        2022-05-23
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