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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Showa Kako

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    01 Calcium Lactate API (1)

    02 Citric Acid (1)

    03 Dimethyl Sulfoxide (1)

    04 Potassium Citrate (1)

    05 Sodium Lactate (4)

    06 Blank (1)

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    01 Inactive (2)

    02 Blank (7)

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    01 Blank (9)

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    01 218MF10598 (1)

    02 218MF10599 (1)

    03 218MF10600 (1)

    04 218MF10737 (1)

    05 218MF11017 (1)

    06 220MF10118 (1)

    07 223MF10062 (1)

    08 Blank (2)

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    01 Blank (9)

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      Calcium Lactate API

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      USDMF

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      CEP/COS

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      Japanese DMF

      Found JDMF

      218MF11017
      Japanese Pharmacopoeia calcium lact...
      2006-12-27
      Written Confirmation

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      Application Number
      218MF11017
      Status
       
      Filing Details
      Japanese Pharmacopoeia calcium lact...
      Issue/Submission Date
      2006-12-27
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        Citric Acid

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        USDMF

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        CEP/COS

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        Japanese DMF

        Found JDMF

        218MF10737
        Japanese Pharmacopoeia sodium citra...
        2006-09-06
        Written Confirmation

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        Application Number
        218MF10737
        Status
         
        Filing Details
        Japanese Pharmacopoeia sodium citra...
        Issue/Submission Date
        2006-09-06
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          Potassium Citrate

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          USDMF

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          CEP/COS

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          Japanese DMF

          Found JDMF

          220MF10118
          Japan Pharmaceutical Codex potassiu...
          2008-04-28
          Written Confirmation

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          Application Number
          220MF10118
          Status
           
          Filing Details
          Japan Pharmaceutical Codex potassiu...
          Issue/Submission Date
          2008-04-28
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            Sodium Lactate

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            USDMF

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            CEP/COS

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            Japanese DMF

            Found JDMF

            223MF10062
            L- sodium lactate solution at 18-23...
            2011-05-12
            Written Confirmation

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            Application Number
            223MF10062
            Status
             
            Filing Details
            L- sodium lactate solution at 18-23...
            Issue/Submission Date
            2011-05-12
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              Sodium Lactate

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              USDMF

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              CEP/COS

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              Japanese DMF

              Found JDMF

              218MF10598
              Sodium lactate solution at 18-23 Yo...
              2006-06-22
              Written Confirmation

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              Application Number
              218MF10598
              Status
               
              Filing Details
              Sodium lactate solution at 18-23 Yo...
              Issue/Submission Date
              2006-06-22
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                Sodium Lactate

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                USDMF

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                CEP/COS

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                Japanese DMF

                Found JDMF

                218MF10599
                Sodium lactate solution at 18-23 Yo...
                2006-06-22
                Written Confirmation

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                Application Number
                218MF10599
                Status
                 
                Filing Details
                Sodium lactate solution at 18-23 Yo...
                Issue/Submission Date
                2006-06-22
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                  Sodium Lactate

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  218MF10600
                  Sodium lactate solution at 18-23 Yo...
                  2006-06-22
                  Written Confirmation

                  Close WC

                  Application Number
                  218MF10600
                  Status
                   
                  Filing Details
                  Sodium lactate solution at 18-23 Yo...
                  Issue/Submission Date
                  2006-06-22
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                    Dimethyl Sulfoxide

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                    USDMF

                    Caution USDMF

                    5236
                    Inactive
                    DIMETHYL SULFOXIDE (DMSO-P)
                    1984-02-10
                    CEP/COS

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                    Japanese DMF

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                    Written Confirmation

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                    Application Number
                    5236
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    DIMETHYL SULFOXIDE (DMSO-P)
                    Issue/Submission Date
                    1984-02-10
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                      FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

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                      USDMF

                      Caution USDMF

                      12114
                      Inactive
                      FACILITIES, PERSONNEL AND GENERAL O...
                      1996-09-03
                      CEP/COS

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                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      12114
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      FACILITIES, PERSONNEL AND GENERAL O...
                      Issue/Submission Date
                      1996-09-03
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