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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Leo Pharma

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    Industriparken 55
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    +45 4494 5888
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      Sodium Fusidate

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      USDMF

      Caution USDMF

      8527
      Inactive
      SODIUM FUSIDATE
      1990-04-16
      CEP/COS

      Found CEP/COS

      R0-CEP 2021-041 - Rev 01
      Valid
      Sodium fusidate, Micronised, Proces...
      2022-01-19
      Japanese DMF

      Found JDMF

      218MF10952
      Fusidic acid sodium at Industrypark...
      2006-11-24
      Written Confirmation

      Close WC

      Application Number
      8527
      R0-CEP 2021-041 - Rev 01
      218MF10952
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      SODIUM FUSIDATE
      Sodium fusidate, Micronised, Proces...
      Fusidic acid sodium at Industrypark...
      Issue/Submission Date
      1990-04-16
      2022-01-19
      2006-11-24
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        Sodium Fusidate

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R0-CEP 2021-042 - Rev 00
        Valid
        Sodium fusidate, Process II
        2021-06-04
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        R0-CEP 2021-042 - Rev 00
        Status
        Valid
         
        Filing Details
        Sodium fusidate, Process II
        Issue/Submission Date
        2021-06-04
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          Sodium Fusidate

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          USDMF

          Close USDMF

          CEP/COS

          Found CEP/COS

          R1-CEP 2009-309 - Rev 00
          Valid
          Sodium fusidate
          2016-07-29
          Japanese DMF

          Close JDMF

          Written Confirmation

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          Application Number
          R1-CEP 2009-309 - Rev 00
          Status
          Valid
           
          Filing Details
          Sodium fusidate
          Issue/Submission Date
          2016-07-29
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            Sodium Fusidate

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            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R1-CEP 2009-317 - Rev 02
            Valid
            Sodium fusidate, Micronised
            2022-01-19
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            R1-CEP 2009-317 - Rev 02
            Status
            Valid
             
            Filing Details
            Sodium fusidate, Micronised
            Issue/Submission Date
            2022-01-19
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              Sodium Fusidate

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              USDMF

              Close USDMF

              CEP/COS

              Caution CEP/COS

              R0-CEP 2009-380 - Rev 00
              Withdrawn by Holder
              Sodium fusidate, Sterile
              2011-11-14
              Japanese DMF

              Close JDMF

              Written Confirmation

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              Application Number
              R0-CEP 2009-380 - Rev 00
              Status
              Withdrawn by Holder
               
              Filing Details
              Sodium fusidate, Sterile
              Issue/Submission Date
              2011-11-14
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