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

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    Kyowa Hakko Bio
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    Ohtemachi Building, 1-6-1,Ohtemachi,Chiyoda-ku, Tokyo, 100-8185, Japan
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    ACEGLUTAMIDE ALUMINUM

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    5337
    N/A
    1984-04-11
    II
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    ACEGLUTAMIDE ALUMINUM GRANULES (KW-...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    5314
    N/A
    1984-04-11
    II
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    ADENOSINE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    8828
    N/A
    1990-11-20
    II
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    ADENOSINE TRIPHOSPHATE DISODIUM

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    9569
    N/A
    1992-03-02
    II
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    AICA-RIBOSIDE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    8405
    N/A
    1990-01-25
    II
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    ALPHA-MERCAPTOPROPIONYLGLYCINE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    6809
    N/A
    1987-02-05
    II
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    AMINO ACID BLEND "KYOWA",TYPE TR-1

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    3223
    N/A
    1978-06-16
    II
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    AMINO ACID MIXTURES

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    KYOWA HAKKO BIO CO LT...
    Inactive
    3407
    N/A
    1979-01-09
    II
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    AMINO ACIDS

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    2631
    N/A
    1976-03-18
    II
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    AMINO ACIDS

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    KYOWA HAKKO BIO CO LT...
    Active
    3131
    N/A
    1978-02-27
    II
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    AMINO ACIDS

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    KYOWA HAKKO BIO CO LT...
    Active
    3149
    Complete
    2013-02-05
    2013-01-25
    1978-03-15
    II
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    AMINOETHYLSULFONIC ACID (TAURINE)

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    KYOWA HAKKO USA INC
    Inactive
    5436
    N/A
    1984-06-25
    II
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    BIMATOPROST DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    21681
    N/A
    2008-06-10
    II
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    BUCILLAMINE BULK SUBSTANCE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    12270
    N/A
    1996-11-22
    II
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    CI-920 (FOSTRIECIN) BULK FORM

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    8745
    N/A
    1990-09-20
    II
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    CITICOLINE MONOSODIUM SALT

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    12724
    N/A
    1997-10-20
    II
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    D-SERINE (BULK SUBSTANCE)

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    KYOWA HAKKO BIO CO LT...
    Inactive
    19001
    N/A
    2005-12-05
    II
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    DACARBAZINE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    6819
    N/A
    1987-01-06
    II
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    DACARBAZINE (

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    3457
    N/A
    1979-02-27
    II
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    DINOPROSTONE DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    11274
    N/A
    1994-12-27
    II
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    DX-52-1 BULK MATERIAL

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    11452
    N/A
    1995-03-24
    II
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    GP531T DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Inactive
    22824
    N/A
    2009-05-29
    II
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    KW-2189 DRUG SUBSTANCE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    12420
    N/A
    1997-03-18
    II
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    L-ALANINE

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    KYOWA HAKKO USA INC
    Inactive
    2621
    N/A
    1976-03-02
    II
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    L-ARGININE, L-ARGININE MONOHYDROCHL...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    2170
    N/A
    1973-10-24
    II
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    L-CYSTINE & DERIVATIVE L-CYSTINE HC...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    2753
    N/A
    1976-10-15
    II
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    L-DOPAMINE HYDROCHLORIDE (3-HYDROXY...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    3060
    N/A
    1977-11-22
    II
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    L-ISOLEUCINE

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    KYOWA HAKKO USA INC
    Inactive
    2623
    N/A
    1976-02-11
    II
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    L-LEUCINE

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    KYOWA HAKKO USA INC
    Inactive
    2622
    N/A
    1976-02-04
    II
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    L-MALIC ACID

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    4101
    N/A
    1981-03-26
    II
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    L-TRYPTOPHAN, L-TYROSINE, L-ASPARTI...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    2247
    N/A
    1974-03-12
    II
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    L-VALINE, L-THREONINE, L-GLUTAMINE

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    KYOWA HAKKO USA INC
    Inactive
    2304
    N/A
    1974-07-16
    II
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    LATANOPROST

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    KYOWA PHARMA CHEMICAL...
    Active
    32989
    N/A
    2018-08-07
    II
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    MANUFACTURING AND QUALITY INFORMATI...

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    KYOWA HAKKO BIO CO LT...
    Inactive
    8893
    N/A
    1990-12-17
    II
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    MANUFACTURING AND QUALITY INFORMATI...

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    KYOWA HAKKO BIO CO LT...
    Active
    7799
    N/A
    1988-12-02
    II
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    • FDA
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    MINOCYCLINE HYDOCHLORIDE, SAKAI PLA...

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    7849
    N/A
    1989-01-04
    II
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    MINOCYCLINE HYDROCHLORIDE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    13755
    N/A
    1998-09-01
    II
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    • FDA
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    MISOPROSTOL DRUG SUBSTANCE

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    DAIICHI FINE CHEMICAL...
    Inactive
    15044
    N/A
    2000-09-13
    II
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    MISOPROSTOL HPMC DISPERSION

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    DAIICHI FINE CHEMICAL...
    Inactive
    15068
    N/A
    2000-09-28
    II
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    MITOMYCIN

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    13521
    N/A
    1998-09-01
    II
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    OLOPATADINE HYDROCHLORIDE DRUG SUBS...

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    KYOWA PHARMA CHEMICAL...
    Active
    28389
    N/A
    2014-06-16
    II
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    PRAVASTATIN SODIUM

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    16975
    N/A
    2003-11-20
    II
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    SODIUM HYALURONATE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    8373
    N/A
    1990-01-11
    II
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    SODIUM HYALURONATE

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    10836
    N/A
    1994-03-30
    II
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    SODIUM SULFADIMETHOXINE

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    DAIICHI FINE CHEMICAL...
    Inactive
    6003
    N/A
    1985-08-13
    II
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    SULFADIMETHOXINE

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    DAIICHI FINE CHEMICAL...
    Inactive
    5995
    N/A
    1985-08-13
    II
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    TRANEXAMIC ACID DRUG SUBSTANCE

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    KYOWA PHARMA CHEMICAL...
    Active
    26128
    Complete
    2016-05-27
    2016-05-23
    2012-06-05
    II
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    UBIDECARENONE BULK

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    14207
    N/A
    1999-05-20
    II
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    URACIL

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    KYOWA HAKKO KOGYO CO ...
    Inactive
    10084
    N/A
    1992-11-30
    II
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    AMINO ACIDS--GENERAL INFO ON BULK D...

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    KYOWA HAKKO USA INC
    Inactive
    2624
    N/A
    1976-03-11
    II
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