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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Nippon Kayaku to the U.S. FDA. Original Data : FDA Website

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    01 AMINO ACID (1)

    02 AUREOBASIDIN A (1)

    03 BOC-AHPBA-OH, INTERMEDIATE OF DRUG SUBSTANCE (1)

    04 BUTADIAMUPLATIN (1)

    05 CARBIDOPA (1)

    06 DEOXYSPERGUALIN HYDROCHLORIDE (1)

    07 DEOXYSPERGUALIN HYDROCHLORIDE FOR INJECTION (1)

    08 ETOPOSIDE (1)

    09 ETOPOSIDE PHOSPHATE (1)

    10 GRISEOFULVIN (1)

    11 L-ALANINE, L-METHIONINE & GLYCINE (1)

    12 L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE (1)

    13 L-~-METHYLDOPA (1)

    14 MINOCYCLINE HYDROCHLORIDE (1)

    15 SUCRALFATE (1)

    16 SULINDAC (1)

    17 UBENIMEX (1)

    18 UBINIMEX (1)

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    01 NIPPON KAYAKU CO LTD (18)

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    01 Japan (18)

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    01 Active (3)

    02 Inactive (15)

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    01 Blank (18)

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      AMINO ACID

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      NIPPON KAYAKU CO LTD
      Inactive
      6062
      N/A
      1985-09-25
      II
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        AUREOBASIDIN A

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        NIPPON KAYAKU CO LTD
        Inactive
        9875
        N/A
        1992-09-24
        II
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          BOC-AHPBA-OH, INTERMEDIATE OF DRUG ...

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          NIPPON KAYAKU CO LTD
          Inactive
          9814
          N/A
          1992-08-10
          II
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            CARBIDOPA

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            NIPPON KAYAKU CO LTD
            Inactive
            7063
            N/A
            1987-06-22
            II
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              DEOXYSPERGUALIN HYDROCHLORIDE

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              NIPPON KAYAKU CO LTD
              Inactive
              6537
              N/A
              1986-08-12
              II
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                DEOXYSPERGUALIN HYDROCHLORIDE FOR I...

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                NIPPON KAYAKU CO LTD
                Inactive
                6533
                N/A
                1986-08-12
                II
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                  ETOPOSIDE

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                  NIPPON KAYAKU CO LTD
                  Active
                  8946
                  N/A
                  1991-01-22
                  II
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                    ETOPOSIDE PHOSPHATE

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                    NIPPON KAYAKU CO LTD
                    Active
                    10476
                    N/A
                    1993-09-17
                    II
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                      GRISEOFULVIN

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                      NIPPON KAYAKU CO LTD
                      Inactive
                      13582
                      N/A
                      1998-09-01
                      II
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                        L-ALANINE, L-METHIONINE & GLYCINE

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                        NIPPON KAYAKU CO LTD
                        Inactive
                        4814
                        N/A
                        1982-12-20
                        II
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