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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Gmt Fine Chemicals Sa

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    01 Calcium Folinate (2)

    02 Dacarbazine (1)

    03 Levoleucovorin Calcium (3)

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    01 Active (2)

    02 Inactive (2)

    03 Blank (2)

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    01 Valid (2)

    02 Blank (4)

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    01 218MF10307 (1)

    02 218MF10451 (1)

    03 227MF10147 (1)

    04 230MF10073 (1)

    05 Blank (2)

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    01 Blank (6)

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      Levoleucovorin Calcium

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      USDMF

      Found USDMF

      25198
      Active
      LEVOLEUCOVORIN CALCIUM
      2011-08-10
      CEP/COS

      Found CEP/COS

      CEP 2008-320 - Rev 07
      Valid
      Calcium levofolinate hydrate
      2024-02-27
      Japanese DMF

      Found JDMF

      218MF10307
      Levofolinate calcium at 6, rue des ...
      2006-02-28
      Written Confirmation

      Close WC

      Application Number
      25198
      CEP 2008-320 - Rev 07
      218MF10307
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      LEVOLEUCOVORIN CALCIUM
      Calcium levofolinate hydrate
      Levofolinate calcium at 6, rue des ...
      Issue/Submission Date
      2011-08-10
      2024-02-27
      2006-02-28
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        Calcium Folinate

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        USDMF

        Caution USDMF

        16718
        Inactive
        LEUCOVORIN CALCIUM, USP
        2003-07-18
        CEP/COS

        Found CEP/COS

        R1-CEP 2004-009 - Rev 03
        Valid
        Calcium folinate hydrate
        2019-03-18
        Japanese DMF

        Found JDMF

        227MF10147
        Calcium folinate at 6, rue des Iles...
        2015-05-20
        Written Confirmation

        Close WC

        Application Number
        16718
        R1-CEP 2004-009 - Rev 03
        227MF10147
        Status
        Inactive
        Fees Paid
        N/A
        Valid
         
        Filing Details
        LEUCOVORIN CALCIUM, USP
        Calcium folinate hydrate
        Calcium folinate at 6, rue des Iles...
        Issue/Submission Date
        2003-07-18
        2019-03-18
        2015-05-20
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          Calcium Folinate

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          USDMF

          Found USDMF

          33740
          Active
          LEUCOVORIN CALCIUM
          2019-05-18
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

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          Application Number
          33740
          Status
          Active
          Fees Paid
          Reviewed
           
          Filing Details
          LEUCOVORIN CALCIUM
          Issue/Submission Date
          2019-05-18
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            Levoleucovorin Calcium

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            USDMF

            Close USDMF

            CEP/COS

            Close CEP/COS

            Japanese DMF

            Found JDMF

            230MF10073
            Levofolinate calcium hydrate at 6, ...
            2018-06-20
            Written Confirmation

            Close WC

            Application Number
            230MF10073
            Status
             
            Filing Details
            Levofolinate calcium hydrate at 6, ...
            Issue/Submission Date
            2018-06-20
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              Levoleucovorin Calcium

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              USDMF

              Close USDMF

              CEP/COS

              Close CEP/COS

              Japanese DMF

              Found JDMF

              218MF10451
              Levofolinate calcium at 6, rue des ...
              2006-04-27
              Written Confirmation

              Close WC

              Application Number
              218MF10451
              Status
               
              Filing Details
              Levofolinate calcium at 6, rue des ...
              Issue/Submission Date
              2006-04-27
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                Dacarbazine

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                USDMF

                Caution USDMF

                16411
                Inactive
                DACARBAZINE USP
                2003-01-31
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                16411
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                DACARBAZINE USP
                Issue/Submission Date
                2003-01-31
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