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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Opocrin Spa

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    01 Dalteparin sodium (1)

    02 Enoxaparin Sodium (1)

    03 Heparin Sodium (4)

    04 Iron Sucrose (1)

    05 Sodium ferric gluconate (1)

    06 Sulodexide (1)

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    01 Active (1)

    02 Inactive (4)

    03 Blank (4)

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    01 Valid (1)

    02 Withdrawn by Holder (1)

    03 Blank (7)

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    01 218MF10415 (1)

    02 218MF10416 (1)

    03 218MF10417 (1)

    04 223MF10011 (1)

    05 227MF10152 (1)

    06 Blank (4)

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    01 Blank (9)

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      Heparin Sodium

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2002-006 - Rev 09
      Valid
      Heparin sodium, For parenteral prep...
      2022-01-12
      Japanese DMF

      Found JDMF

      223MF10011
      Japanese Pharmacopoeia heparin calc...
      2011-01-21
      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2002-006 - Rev 09
      223MF10011
      Status
      Valid
       
      Filing Details
      Heparin sodium, For parenteral prep...
      Japanese Pharmacopoeia heparin calc...
      Issue/Submission Date
      2022-01-12
      2011-01-21
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        Dalteparin sodium

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        USDMF

        Caution USDMF

        19658
        Inactive
        DALTEPARIN SODIUM BULK
        2006-08-04
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Found JDMF

        227MF10152
        Dalteparin Sodium at Via Pacinotti,...
        2015-06-01
        Written Confirmation

        Close WC

        Application Number
        19658
        227MF10152
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        DALTEPARIN SODIUM BULK
        Dalteparin Sodium at Via Pacinotti,...
        Issue/Submission Date
        2006-08-04
        2015-06-01
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          Enoxaparin Sodium

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          USDMF

          Caution USDMF

          16748
          Inactive
          ENOXAPARIN SODIUM
          2003-08-08
          CEP/COS

          Caution CEP/COS

          R1-CEP 2004-014 - Rev 01
          Withdrawn by Holder
          Enoxaparin sodium
          2010-08-05
          Japanese DMF

          Close JDMF

          Written Confirmation

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          Application Number
          16748
          R1-CEP 2004-014 - Rev 01
          Status
          Inactive
          Fees Unpaid
          N/A
          Withdrawn by Holder
           
          Filing Details
          ENOXAPARIN SODIUM
          Enoxaparin sodium
          Issue/Submission Date
          2003-08-08
          2010-08-05
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            Heparin Sodium

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            USDMF

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            CEP/COS

            Close CEP/COS

            Japanese DMF

            Found JDMF

            218MF10416
            Japanese Pharmacopoeia heparin sodi...
            2006-04-27
            Written Confirmation

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            Application Number
            218MF10416
            Status
             
            Filing Details
            Japanese Pharmacopoeia heparin sodi...
            Issue/Submission Date
            2006-04-27
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              Heparin Sodium

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              USDMF

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              CEP/COS

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              Japanese DMF

              Found JDMF

              218MF10417
              Japan Pharmaceutical Codex heparin ...
              2006-04-27
              Written Confirmation

              Close WC

              Application Number
              218MF10417
              Status
               
              Filing Details
              Japan Pharmaceutical Codex heparin ...
              Issue/Submission Date
              2006-04-27
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                Heparin Sodium

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                USDMF

                Close USDMF

                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                218MF10415
                Parnaparin sodium \"Fujikawa\" at V...
                2006-04-27
                Written Confirmation

                Close WC

                Application Number
                218MF10415
                Status
                 
                Filing Details
                Parnaparin sodium \"Fujikawa\" at V...
                Issue/Submission Date
                2006-04-27
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                  Iron Sucrose

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                  USDMF

                  Found USDMF

                  33020
                  Active
                  IRON SUCROSE
                  2018-08-09
                  CEP/COS

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                  Japanese DMF

                  Close JDMF

                  Written Confirmation

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                  Application Number
                  33020
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Filing Details
                  IRON SUCROSE
                  Issue/Submission Date
                  2018-08-09
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                    Sodium ferric gluconate

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                    USDMF

                    Caution USDMF

                    17645
                    Inactive
                    SODIUM FERRIC GLUCONATE
                    2004-08-30
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

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                    Application Number
                    17645
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    SODIUM FERRIC GLUCONATE
                    Issue/Submission Date
                    2004-08-30
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                      Sulodexide

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                      USDMF

                      Caution USDMF

                      14874
                      Inactive
                      SULODEXIDE
                      2000-05-10
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      14874
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      SULODEXIDE
                      Issue/Submission Date
                      2000-05-10
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