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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi Austria

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    01 Cornstarch (2)

    02 Lactulose (5)

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    01 Active (3)

    02 Inactive (1)

    03 Blank (3)

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    01 Valid (7)

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      Lactulose

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      USDMF

      Found USDMF

      15253
      Active
      LACTULOSE SOLUTION USP
      2001-02-16
      CEP/COS

      Found CEP/COS

      R1-CEP 2005-023 - Rev 02
      Valid
      Lactulose, liquid
      2017-09-07
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      15253
      R1-CEP 2005-023 - Rev 02
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      LACTULOSE SOLUTION USP
      Lactulose, liquid
      Issue/Submission Date
      2001-02-16
      2017-09-07
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        Lactulose

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        USDMF

        Found USDMF

        15254
        Active
        LACTULOSE CRYSTALS
        2001-02-16
        CEP/COS

        Found CEP/COS

        R1-CEP 2002-236 - Rev 03
        Valid
        Lactulose
        2017-10-11
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        15254
        R1-CEP 2002-236 - Rev 03
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Filing Details
        LACTULOSE CRYSTALS
        Lactulose
        Issue/Submission Date
        2001-02-16
        2017-10-11
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          Lactulose

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          USDMF

          Found USDMF

          20562
          Active
          LACTULOSE CONCENTRATE USP
          2007-05-29
          CEP/COS

          Found CEP/COS

          R0-CEP 2019-138 - Rev 00
          Valid
          Lactulose, liquid, 667 g/L
          2019-11-15
          Japanese DMF

          Close JDMF

          Written Confirmation

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          Application Number
          20562
          R0-CEP 2019-138 - Rev 00
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          LACTULOSE CONCENTRATE USP
          Lactulose, liquid, 667 g/L
          Issue/Submission Date
          2007-05-29
          2019-11-15
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            Lactulose

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            USDMF

            Caution USDMF

            22328
            Inactive
            LACTULOSE SOLUTION USP
            2008-12-20
            CEP/COS

            Found CEP/COS

            R1-CEP 1998-130 - Rev 03
            Valid
            Lactulose, liquid, 670 g/l
            2007-11-30
            Japanese DMF

            Close JDMF

            Written Confirmation

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            Application Number
            22328
            R1-CEP 1998-130 - Rev 03
            Status
            Inactive
            Fees Paid
            N/A
            Valid
             
            Filing Details
            LACTULOSE SOLUTION USP
            Lactulose, liquid, 670 g/l
            Issue/Submission Date
            2008-12-20
            2007-11-30
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              Cornstarch

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              USDMF

              Close USDMF

              CEP/COS

              Found CEP/COS

              R1-CEP 2010-242 - Rev 00
              Valid
              Starches, hydroxyethyl, Mw 200, MS ...
              2017-06-29
              Japanese DMF

              Close JDMF

              Written Confirmation

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              Application Number
              R1-CEP 2010-242 - Rev 00
              Status
              Valid
               
              Filing Details
              Starches, hydroxyethyl, Mw 200, MS ...
              Issue/Submission Date
              2017-06-29
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                Cornstarch

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                USDMF

                Close USDMF

                CEP/COS

                Found CEP/COS

                R1-CEP 2010-284 - Rev 00
                Valid
                Starches, hydroxyethyl, Mw 450, MS ...
                2017-06-29
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                R1-CEP 2010-284 - Rev 00
                Status
                Valid
                 
                Filing Details
                Starches, hydroxyethyl, Mw 450, MS ...
                Issue/Submission Date
                2017-06-29
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                PHARMACOMPASS
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                your Marketing & Sales content
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                  Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
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                  Flag Austria
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                  Lactulose

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                  USDMF

                  Close USDMF

                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2015-187 - Rev 00
                  Valid
                  Lactulose, liquid, with sodium benz...
                  2020-10-30
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  R1-CEP 2015-187 - Rev 00
                  Status
                  Valid
                   
                  Filing Details
                  Lactulose, liquid, with sodium benz...
                  Issue/Submission Date
                  2020-10-30
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                  PHARMACOMPASS
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