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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Kaken Pharmaceuticals

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    01 Butenafine Hydrochloride (1)

    02 Colistin Sulfate (1)

    03 Dofetilide (1)

    04 Efinaconazole (4)

    05 Pralmorelin (1)

    06 Sofpironium Bromide (1)

    07 Blank (4)

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    01 Active (6)

    02 Inactive (4)

    03 Blank (3)

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    01 Expired (1)

    02 Blank (12)

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    01 217MF10389 (1)

    02 217MF10390 (1)

    03 228MF40013 (1)

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    01 Blank (13)

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      Butenafine Hydrochloride

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      USDMF

      Found USDMF

      11296
      Active
      BUTENEAFINE HYDROCHLORIDE
      1995-01-09
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      217MF10389
      Hydrochloric acid butenafine at 2-2...
      2005-07-27
      Written Confirmation

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      Application Number
      11296
      217MF10389
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      BUTENEAFINE HYDROCHLORIDE
      Hydrochloric acid butenafine at 2-2...
      Issue/Submission Date
      1995-01-09
      2005-07-27
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        Dofetilide

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        USDMF

        Found USDMF

        30794
        Active
        KP-470
        2018-05-30
        CEP/COS

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        Application Number
        30794
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        KP-470
        Issue/Submission Date
        2018-05-30
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          Efinaconazole

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          USDMF

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          21870
          Active
          KP-103/B
          2008-07-25
          CEP/COS

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          Application Number
          21870
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          KP-103/B
          Issue/Submission Date
          2008-07-25
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            Efinaconazole

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            USDMF

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            27081
            Active
            EFINACONAZOLE
            2013-05-24
            CEP/COS

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            Application Number
            27081
            Status
            Active
            Fees Unpaid
            N/A
             
            Filing Details
            EFINACONAZOLE
            Issue/Submission Date
            2013-05-24
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              Efinaconazole

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              USDMF

              Found USDMF

              37590
              Active
              EFINACONAZOLE\K
              2022-12-02
              CEP/COS

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              Application Number
              37590
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              EFINACONAZOLE\K
              Issue/Submission Date
              2022-12-02
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                Sofpironium Bromide

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                USDMF

                Found USDMF

                31310
                Active
                SOFPIRONIUM BROMIDE
                2017-09-22
                CEP/COS

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                Japanese DMF

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                Written Confirmation

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                Application Number
                31310
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                SOFPIRONIUM BROMIDE
                Issue/Submission Date
                2017-09-22
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                  Pronase

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  217MF10390
                  Pronase at 2-28-8 Honkomagome, Bunk...
                  2005-07-27
                  Written Confirmation

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                  Application Number
                  217MF10390
                  Status
                   
                  Filing Details
                  Pronase at 2-28-8 Honkomagome, Bunk...
                  Issue/Submission Date
                  2005-07-27
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                    Medium / medium additive · bFGF Solution, MF

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                    USDMF

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                    CEP/COS

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                    Japanese DMF

                    Found JDMF

                    228MF40013
                    Medium / medium additive · bFGF So...
                    2016-05-26
                    Written Confirmation

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                    Application Number
                    228MF40013
                    Status
                     
                    Filing Details
                    Medium / medium additive · bFGF So...
                    Issue/Submission Date
                    2016-05-26
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                      Colistin Sulfate

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                      USDMF

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                      CEP/COS

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                      R0-CEP 2004-106 - Rev 00
                      Expired
                      Colistin sulfate
                      2006-03-20
                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      R0-CEP 2004-106 - Rev 00
                      Status
                      Expired
                       
                      Filing Details
                      Colistin sulfate
                      Issue/Submission Date
                      2006-03-20
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                        Efinaconazole

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                        USDMF

                        Caution USDMF

                        20533
                        Inactive
                        KP-103
                        2007-05-01
                        CEP/COS

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                        Japanese DMF

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                        Written Confirmation

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                        Application Number
                        20533
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        KP-103
                        Issue/Submission Date
                        2007-05-01
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