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

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    01 Lactitol (1)

    02 Lactulose (4)

    03 Tagatose (1)

    04 Blank (4)

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    01 Active (4)

    02 Inactive (6)

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    01 Expired (1)

    02 Valid (1)

    03 Withdrawn by Holder (1)

    04 Blank (7)

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    01 Blank (10)

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      Lactulose

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      USDMF

      Found USDMF

      5412
      Active
      LACTULOSE 50% SYRUP
      1984-02-07
      CEP/COS

      Found CEP/COS

      R0-CEP 2019-324 - Rev 00
      Valid
      Lactulose, liquid, Process II, 670 ...
      2020-05-19
      Japanese DMF

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      Written Confirmation

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      Application Number
      5412
      R0-CEP 2019-324 - Rev 00
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      LACTULOSE 50% SYRUP
      Lactulose, liquid, Process II, 670 ...
      Issue/Submission Date
      1984-02-07
      2020-05-19
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        Lactitol

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        USDMF

        Found USDMF

        27765
        Active
        LACTITOL MONOHYDRATE
        2013-11-21
        CEP/COS

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        Japanese DMF

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        Written Confirmation

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        Application Number
        27765
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        LACTITOL MONOHYDRATE
        Issue/Submission Date
        2013-11-21
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          Lactulose

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          USDMF

          Caution USDMF

          7682
          Inactive
          PURIFIED LACTULOSE SYRUP
          1988-09-20
          CEP/COS

          Caution CEP/COS

          R1-CEP 1999-145 - Rev 02
          Withdrawn by Holder
          Lactulose, liquid, 63.4% -70.0% w/v
          2014-05-13
          Japanese DMF

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          Application Number
          7682
          R1-CEP 1999-145 - Rev 02
          Status
          Inactive
          Fees Unpaid
          N/A
          Withdrawn by Holder
           
          Filing Details
          PURIFIED LACTULOSE SYRUP
          Lactulose, liquid, 63.4% -70.0% w/v
          Issue/Submission Date
          1988-09-20
          2014-05-13
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            Lactulose

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            USDMF

            Caution USDMF

            9537
            Inactive
            LACTULOSE CRYSTALS
            1992-01-30
            CEP/COS

            Caution CEP/COS

            R0-CEP 2001-238 - Rev 01
            Expired
            Lactulose
            2004-11-15
            Japanese DMF

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            Written Confirmation

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            Application Number
            9537
            R0-CEP 2001-238 - Rev 01
            Status
            Inactive
            Fees Unpaid
            N/A
            Expired
             
            Filing Details
            LACTULOSE CRYSTALS
            Lactulose
            Issue/Submission Date
            1992-01-30
            2004-11-15
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              Tagatose

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              USDMF

              Found USDMF

              22715
              Active
              D-(-)-TAGATOSE
              2009-04-07
              CEP/COS

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              Japanese DMF

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              Written Confirmation

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              Application Number
              22715
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              D-(-)-TAGATOSE
              Issue/Submission Date
              2009-04-07
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                GOS 95

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                USDMF

                Found USDMF

                23206
                Active
                GOS 95
                2009-10-20
                CEP/COS

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                Japanese DMF

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                Written Confirmation

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                Application Number
                23206
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                GOS 95
                Issue/Submission Date
                2009-10-20
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                  Lactulose

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                  USDMF

                  Caution USDMF

                  11262
                  Inactive
                  LACTULOSE CRYSTALS
                  1994-12-25
                  CEP/COS

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                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  11262
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  LACTULOSE CRYSTALS
                  Issue/Submission Date
                  1994-12-25
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                    MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL O...

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                    USDMF

                    Caution USDMF

                    11261
                    Inactive
                    MANUFACTURING SITE, FACILITIES, PER...
                    1994-11-25
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

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                    Written Confirmation

                    Close WC

                    Application Number
                    11261
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    MANUFACTURING SITE, FACILITIES, PER...
                    Issue/Submission Date
                    1994-11-25
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                      MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATIN...

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                      USDMF

                      Caution USDMF

                      12199
                      Inactive
                      MANUFACTURING SITES, FACILITIES, PE...
                      1996-10-30
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      12199
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      MANUFACTURING SITES, FACILITIES, PE...
                      Issue/Submission Date
                      1996-10-30
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                        2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-GLUCOPYRANOSIDE (DBE...

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                        USDMF

                        Caution USDMF

                        12200
                        Inactive
                        2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-...
                        1996-10-30
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        12200
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-...
                        Issue/Submission Date
                        1996-10-30
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