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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Nippon Kayaku

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    01 Ambotzbaa1319 (1)

    02 Amino Acids Mixture (1)

    03 Aureobasidin E (1)

    04 Bleomycin (1)

    05 Bortezomib (1)

    06 Carbidopa (1)

    07 Colistimethate Sodium (1)

    08 Etoposide (1)

    09 Etoposide Phosphate (1)

    10 Griseofulvin (1)

    11 Gusperimus (2)

    12 Isoleucine (1)

    13 L-Alanine API (1)

    14 Methyldopa (1)

    15 Minocycline Hydrochloride (1)

    16 Pemetrexed Disodium (1)

    17 Sucralfate (1)

    18 Sulindac (1)

    19 Voglibose (1)

    20 Zoledronic Acid (1)

    21 ubenimex (1)

    22 Blank (2)

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    01 Active (3)

    02 Inactive (15)

    03 Blank (6)

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    01 Valid (2)

    02 Withdrawn by Holder (1)

    03 Blank (21)

    filter

    01 217MF10573 (1)

    02 218MF10189 (1)

    03 225MF10012 (1)

    04 227MF10038 (1)

    05 230MF10025 (1)

    06 Blank (19)

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    01 Blank (24)

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      Etoposide

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      USDMF

      Found USDMF

      8946
      Active
      ETOPOSIDE
      1991-01-22
      CEP/COS

      Found CEP/COS

      R1-CEP 2004-003 - Rev 03
      Valid
      Etoposide
      2015-08-12
      Japanese DMF

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      Written Confirmation

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      Application Number
      8946
      R1-CEP 2004-003 - Rev 03
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      ETOPOSIDE
      Etoposide
      Issue/Submission Date
      1991-01-22
      2015-08-12
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        Bleomycin

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        CEP 2002-149 - Rev 05
        Valid
        Bleomycin Sulfate
        2023-12-12
        Japanese DMF

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        Written Confirmation

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        Application Number
        CEP 2002-149 - Rev 05
        Status
        Valid
         
        Filing Details
        Bleomycin Sulfate
        Issue/Submission Date
        2023-12-12
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          Bortezomib

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          USDMF

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          CEP/COS

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          Japanese DMF

          Found JDMF

          230MF10025
          Bortezomib \"NK\" at 2-1-1 Marunouc...
          2018-02-15
          Written Confirmation

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          Application Number
          230MF10025
          Status
           
          Filing Details
          Bortezomib \"NK\" at 2-1-1 Marunouc...
          Issue/Submission Date
          2018-02-15
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            Colistimethate Sodium

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            USDMF

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            CEP/COS

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            Japanese DMF

            Found JDMF

            217MF10573
            Colistin sodium methanesulfonate (p...
            2005-09-09
            Written Confirmation

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            Application Number
            217MF10573
            Status
             
            Filing Details
            Colistin sodium methanesulfonate (p...
            Issue/Submission Date
            2005-09-09
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              Etoposide Phosphate

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              USDMF

              Found USDMF

              10476
              Active
              ETOPOSIDE PHOSPHATE
              1993-09-17
              CEP/COS

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              Japanese DMF

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              Application Number
              10476
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              ETOPOSIDE PHOSPHATE
              Issue/Submission Date
              1993-09-17
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                Minocycline Hydrochloride

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                USDMF

                Caution USDMF

                13748
                Inactive
                MINOCYCLINE HYDROCHLORIDE
                1998-09-01
                CEP/COS

                Caution CEP/COS

                R0-CEP 1999-072 - Rev 02
                Withdrawn by Holder
                Minocycline hydrochloride dihydrate
                2004-08-20
                Japanese DMF

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                Written Confirmation

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                Application Number
                13748
                R0-CEP 1999-072 - Rev 02
                Status
                Inactive
                Fees Unpaid
                N/A
                Withdrawn by Holder
                 
                Filing Details
                MINOCYCLINE HYDROCHLORIDE
                Minocycline hydrochloride dihydrate
                Issue/Submission Date
                1998-09-01
                2004-08-20
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                  Pemetrexed Disodium

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  227MF10038
                  Pemetrexed sodium hemi-pentahydrate...
                  2015-02-09
                  Written Confirmation

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                  Application Number
                  227MF10038
                  Status
                   
                  Filing Details
                  Pemetrexed sodium hemi-pentahydrate...
                  Issue/Submission Date
                  2015-02-09
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                    ubenimex

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                    USDMF

                    Found USDMF

                    29536
                    Active
                    UBENIMEX
                    2015-07-31
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

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                    Written Confirmation

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                    Application Number
                    29536
                    Status
                    Active
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    UBENIMEX
                    Issue/Submission Date
                    2015-07-31
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                      Voglibose

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                      USDMF

                      Close USDMF

                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Found JDMF

                      218MF10189
                      Voglibose \"NK\" at 2-1-1 Marunouch...
                      2006-02-08
                      Written Confirmation

                      Close WC

                      Application Number
                      218MF10189
                      Status
                       
                      Filing Details
                      Voglibose \"NK\" at 2-1-1 Marunouch...
                      Issue/Submission Date
                      2006-02-08
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                        Zoledronic Acid

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                        USDMF

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                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Found JDMF

                        225MF10012
                        Zoledronic acid hydrate \"NK\" at 2...
                        2013-01-30
                        Written Confirmation

                        Close WC

                        Application Number
                        225MF10012
                        Status
                         
                        Filing Details
                        Zoledronic acid hydrate \"NK\" at 2...
                        Issue/Submission Date
                        2013-01-30
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