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

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    01 ASKP1240 MONOCLONAL ANTIBODY DRUG SUBSTANCE AND DRUG PRODUCT (1)

    02 ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE (1)

    03 KRN5500 DRUG SUBSTANCE (1)

    04 KRN7000 (1)

    05 KW-6356 DRUG SUBSTANCE (1)

    06 OLOPATADINE HYDROCHLORIDE (KW 4679) (1)

    07 UCN-01 (KW-2401) BULK SUBSTANCE (1)

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    01 KYOWA HAKKO KIRIN CO LTD (4)

    02 KYOWA KIRIN CO LTD (3)

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    01 Japan (7)

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    02 Inactive (6)

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      ISTRADEFYLLINE (KW-6002) DRUG SUBST...

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      KYOWA HAKKO KIRIN CO ...
      Inactive
      23936
      N/A
      2010-07-01
      II
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        KRN5500 DRUG SUBSTANCE

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        KYOWA HAKKO KIRIN CO ...
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        13112
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        1998-08-05
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          KRN7000

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          KYOWA HAKKO KIRIN CO ...
          Inactive
          15238
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          2001-01-12
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            OLOPATADINE HYDROCHLORIDE (KW 4679)

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            KYOWA KIRIN CO LTD
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            11801
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            1996-01-10
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              UCN-01 (KW-2401) BULK SUBSTANCE

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              KYOWA HAKKO KIRIN CO ...
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              11319
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              1995-01-20
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                ASKP1240 MONOCLONAL ANTIBODY DRUG S...

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                KYOWA KIRIN CO LTD
                Inactive
                21606
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                2008-05-08
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                  KW-6356 DRUG SUBSTANCE

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                  KYOWA KIRIN CO LTD
                  Inactive
                  28704
                  N/A
                  2014-11-06
                  II
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