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

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    01 Alfacalcidol (1)

    02 Amdinocillin (2)

    03 Bumetanide (1)

    04 Calcipotriol (8)

    05 Dalteparin sodium (1)

    06 Fusidic Acid (4)

    07 Heparin Sodium (4)

    08 Pivmecilinamo Clorhidrato (1)

    09 Seocalcitol (1)

    10 Sodium Fusidate (5)

    11 Sodium Taurodihydrofusidate (1)

    12 Blank (8)

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    01 Active (2)

    02 Inactive (30)

    03 Blank (5)

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    01 Valid (11)

    02 Withdrawn by Holder (2)

    03 Blank (24)

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    01 218MF10952 (1)

    02 219MF10045 (1)

    03 Blank (35)

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    01 Blank (37)

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      Calcipotriol

      PDF Supplier PDF
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      USDMF

      Caution USDMF

      8308
      Inactive
      CALCIPOTRIENE DRUG SUBSTANCE
      1989-11-01
      CEP/COS

      Found CEP/COS

      R1-CEP 2005-148 - Rev 01
      Valid
      Calcipotriol
      2013-03-13
      Japanese DMF

      Found JDMF

      219MF10045
      Calcipotriol at Industryparken 55, ...
      2007-02-13
      Written Confirmation

      Close WC

      Application Number
      8308
      R1-CEP 2005-148 - Rev 01
      219MF10045
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      CALCIPOTRIENE DRUG SUBSTANCE
      Calcipotriol
      Calcipotriol at Industryparken 55, ...
      Issue/Submission Date
      1989-11-01
      2013-03-13
      2007-02-13
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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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          Calcipotriol

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          USDMF

          Caution USDMF

          8312
          Inactive
          CALCIPOTRIENE OINTMENT
          1989-11-27
          CEP/COS

          Found CEP/COS

          R1-CEP 2005-145 - Rev 01
          Valid
          Calcipotriol monohydrate
          2013-04-09
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          8312
          R1-CEP 2005-145 - Rev 01
          Status
          Inactive
          Fees Unpaid
          N/A
          Valid
           
          Filing Details
          CALCIPOTRIENE OINTMENT
          Calcipotriol monohydrate
          Issue/Submission Date
          1989-11-27
          2013-04-09
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            Fusidic Acid

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            USDMF

            Caution USDMF

            8526
            Inactive
            FUSIDIC ACID
            1990-04-16
            CEP/COS

            Found CEP/COS

            R0-CEP 2021-040 - Rev 01
            Valid
            Fusidic acid, Micronised, Process I...
            2022-01-19
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            8526
            R0-CEP 2021-040 - Rev 01
            Status
            Inactive
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            FUSIDIC ACID
            Fusidic acid, Micronised, Process I...
            Issue/Submission Date
            1990-04-16
            2022-01-19
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              Fusidic Acid

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              USDMF

              Caution USDMF

              8528
              Inactive
              FUCIDIN CREAM
              1990-04-16
              CEP/COS

              Found CEP/COS

              R1-CEP 2009-308 - Rev 02
              Valid
              Fusidic acid, Micronised
              2022-01-19
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              8528
              R1-CEP 2009-308 - Rev 02
              Status
              Inactive
              Fees Unpaid
              N/A
              Valid
               
              Filing Details
              FUCIDIN CREAM
              Fusidic acid, Micronised
              Issue/Submission Date
              1990-04-16
              2022-01-19
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                Fusidic Acid

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                USDMF

                Caution USDMF

                8529
                Inactive
                FUCIDIN OINTMENT
                1990-04-16
                CEP/COS

                Found CEP/COS

                R1-CEP 2009-379 - Rev 00
                Valid
                Fusidic acid, Micronised, sterile
                2016-10-21
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                8529
                R1-CEP 2009-379 - Rev 00
                Status
                Inactive
                Fees Unpaid
                N/A
                Valid
                 
                Filing Details
                FUCIDIN OINTMENT
                Fusidic acid, Micronised, sterile
                Issue/Submission Date
                1990-04-16
                2016-10-21
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                  Heparin Sodium

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                  USDMF

                  Caution USDMF

                  10477
                  Inactive
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  1993-09-03
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2001-446 - Rev 03
                  Valid
                  Heparin sodium, For parenteral prep...
                  2020-02-21
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  10477
                  R1-CEP 2001-446 - Rev 03
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                  Valid
                   
                  Filing Details
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  Heparin sodium, For parenteral prep...
                  Issue/Submission Date
                  1993-09-03
                  2020-02-21
                  ASK
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                    Alfacalcidol

                    PDF Supplier PDF
                    URL Supplier Web Content
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                    See Less

                    USDMF

                    Close USDMF

                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2007-286 - Rev 02
                    Valid
                    Alfacalcidol
                    2020-02-18
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    R1-CEP 2007-286 - Rev 02
                    Status
                    Valid
                     
                    Filing Details
                    Alfacalcidol
                    Issue/Submission Date
                    2020-02-18
                    ASK
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                      Calcipotriol

                      PDF Supplier PDF
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                      See Less

                      USDMF

                      Found USDMF

                      10514
                      Active
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      1993-10-08
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      10514
                      Status
                      Active
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      Issue/Submission Date
                      1993-10-08
                      ASK
                      US
                      PHARMACOMPASS
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                      your Marketing & Sales content
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                        Calcipotriol

                        PDF Supplier PDF
                        URL Supplier Web Content
                        See all info for this product

                        See Less

                        USDMF

                        Found USDMF

                        10515
                        Active
                        CALCIPOTRIENE CREAM
                        1993-10-08
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        10515
                        Status
                        Active
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        CALCIPOTRIENE CREAM
                        Issue/Submission Date
                        1993-10-08
                        ASK
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                        PHARMACOMPASS
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