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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Katsura Chemical

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    01 Atropine Sulfate (2)

    02 Azosemide (1)

    03 Benzo-Thiazole-Aniline-1-Methyl (1)

    04 Carbamazepine (1)

    05 Dobutamine Hydrochloride (1)

    06 Dopamine (1)

    07 Gabexate Mesylate (1)

    08 Gabexato (1)

    09 Levocabastine (2)

    10 Nafamostat (2)

    11 Nipradilol (1)

    12 Pindolol (1)

    13 Pridinol (1)

    14 Procaine (1)

    15 Tetrahydrozoline nitrate (1)

    16 Timiperone (1)

    17 Zotepine (1)

    18 propericiazine (1)

    19 Blank (1)

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    01 Active (1)

    02 Inactive (3)

    03 Blank (18)

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    01 Valid (2)

    02 Blank (20)

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    01 218MF10271 (1)

    02 218MF10272 (1)

    03 218MF10460 (1)

    04 218MF10897 (1)

    05 218MF10995 (1)

    06 219MF10155 (1)

    07 219MF10238 (1)

    08 219MF10239 (1)

    09 219MF10240 (1)

    10 220MF10200 (1)

    11 220MF10201 (1)

    12 221MF10005 (1)

    13 221MF10147 (1)

    14 221MF10250 (1)

    15 223MF10091 (1)

    16 230MF10168 (1)

    17 301MF10084 (1)

    18 303MF10180 (1)

    19 Blank (4)

    filter

    01 Blank (22)

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      Levocabastine

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      USDMF

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      CEP/COS

      Found CEP/COS

      R0-CEP 2018-217 - Rev 00
      Valid
      Levocabastine hydrochloride, Proces...
      2019-05-28
      Japanese DMF

      Found JDMF

      218MF10995
      Levocabastine hydrochloride at 4-15...
      2006-12-18
      Written Confirmation

      Close WC

      Application Number
      R0-CEP 2018-217 - Rev 00
      218MF10995
      Status
      Valid
       
      Filing Details
      Levocabastine hydrochloride, Proces...
      Levocabastine hydrochloride at 4-15...
      Issue/Submission Date
      2019-05-28
      2006-12-18
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        Levocabastine

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        USDMF

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        CEP/COS

        Found CEP/COS

        R1-CEP 2014-277 - Rev 00
        Valid
        Levocabastine hydrochloride
        2021-10-27
        Japanese DMF

        Found JDMF

        230MF10168
        Levocabastine Hydrochloride-K at 4-...
        2018-12-19
        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2014-277 - Rev 00
        230MF10168
        Status
        Valid
         
        Filing Details
        Levocabastine hydrochloride
        Levocabastine Hydrochloride-K at 4-...
        Issue/Submission Date
        2021-10-27
        2018-12-19
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          Nafamostat

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          USDMF

          Found USDMF

          36042
          Active
          NAFAMOSTAT MESILATE-K (USAN: NAFAMO...
          2021-12-09
          CEP/COS

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          Japanese DMF

          Found JDMF

          223MF10091
          Nafamostat mesylate -K at 4-15-19 H...
          2011-06-29
          Written Confirmation

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          Application Number
          36042
          223MF10091
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          NAFAMOSTAT MESILATE-K (USAN: NAFAMO...
          Nafamostat mesylate -K at 4-15-19 H...
          Issue/Submission Date
          2021-12-09
          2011-06-29
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            Atropine Sulfate

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            USDMF

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            CEP/COS

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            Japanese DMF

            Found JDMF

            303MF10180
            Atropine Sulfate Hydrate-K at 4-15-...
            2021-12-15
            Written Confirmation

            Close WC

            Application Number
            303MF10180
            Status
             
            Filing Details
            Atropine Sulfate Hydrate-K at 4-15-...
            Issue/Submission Date
            2021-12-15
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              Atropine Sulfate

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              USDMF

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              CEP/COS

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              Japanese DMF

              Found JDMF

              221MF10005
              Atropine sulfate hydrate at 4-15-19...
              2009-01-13
              Written Confirmation

              Close WC

              Application Number
              221MF10005
              Status
               
              Filing Details
              Atropine sulfate hydrate at 4-15-19...
              Issue/Submission Date
              2009-01-13
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                Azosemide

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                USDMF

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                CEP/COS

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                Japanese DMF

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                221MF10250
                Azosemide at 4-15-19 Hibarigaoka, Z...
                2009-11-24
                Written Confirmation

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                Application Number
                221MF10250
                Status
                 
                Filing Details
                Azosemide at 4-15-19 Hibarigaoka, Z...
                Issue/Submission Date
                2009-11-24
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                  Carbamazepine

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  218MF10271
                  Carbamazepine at 4-15-19 Hibarigaok...
                  2006-02-17
                  Written Confirmation

                  Close WC

                  Application Number
                  218MF10271
                  Status
                   
                  Filing Details
                  Carbamazepine at 4-15-19 Hibarigaok...
                  Issue/Submission Date
                  2006-02-17
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                    Dobutamine Hydrochloride

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                    USDMF

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                    CEP/COS

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                    Japanese DMF

                    Found JDMF

                    219MF10239
                    Dobutamine hydrochloride at 4-15-19...
                    2007-07-17
                    Written Confirmation

                    Close WC

                    Application Number
                    219MF10239
                    Status
                     
                    Filing Details
                    Dobutamine hydrochloride at 4-15-19...
                    Issue/Submission Date
                    2007-07-17
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                      Dopamine

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                      USDMF

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                      CEP/COS

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                      Japanese DMF

                      Found JDMF

                      218MF10897
                      Dopamine hydrochloride at 4-15-19 H...
                      2006-11-10
                      Written Confirmation

                      Close WC

                      Application Number
                      218MF10897
                      Status
                       
                      Filing Details
                      Dopamine hydrochloride at 4-15-19 H...
                      Issue/Submission Date
                      2006-11-10
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                        Gabexato

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                        USDMF

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                        CEP/COS

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                        Japanese DMF

                        Found JDMF

                        219MF10238
                        Gabexate mesylate at 4-15-19 Hibari...
                        2007-07-17
                        Written Confirmation

                        Close WC

                        Application Number
                        219MF10238
                        Status
                         
                        Filing Details
                        Gabexate mesylate at 4-15-19 Hibari...
                        Issue/Submission Date
                        2007-07-17
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