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

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    Daiichi Sankyo
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    • FDA
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    BENICAR HCTR (OLMESARTAN MEDOXOMIL ...

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    DAIICHI SANKYO CO LTD
    Inactive
    19629
    N/A
    2006-07-25
    II
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    BENICAR(TM) TABLETS 5 MG, 20 MG AND...

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    DAIICHI SANKYO CO LTD
    Inactive
    17685
    N/A
    2004-09-14
    II
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    BULK FORM OF NIMUSTINE HCL (NIDRAN)

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    SANKYO CO LTD
    Inactive
    5461
    N/A
    1984-07-20
    II
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    CARPERITIDE DRUG SUBSTANCE

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    ASUBIO PHARMA CO LTD
    Inactive
    14238
    N/A
    1999-06-28
    II
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    CEFMETAZOLE (FREE ACID)

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    SANKYO CO LTD
    Inactive
    9887
    N/A
    1982-09-03
    II
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    CEFMETAZOLE SODIUM INJECTION(VIALS)

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    SANKYO CO LTD
    Inactive
    5952
    N/A
    1985-08-14
    II
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    CETRAXATE HCl CAPSULES

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    DAIICHI SANKYO CO LTD
    Inactive
    4448
    N/A
    1982-02-05
    II
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    CETRAXATE HYDROCHLORIDE

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    DAIICHI SANKYO CO LTD
    Inactive
    4443
    N/A
    1982-02-05
    II
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    • FDA
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    CS-023 DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    17229
    N/A
    2004-03-12
    II
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    CS-088 DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    17461
    N/A
    2004-06-14
    II
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    CS-514BULK SUBSTANCE PROCESSED TANA...

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    SANKYO CO LTD
    Inactive
    5968
    N/A
    1985-08-29
    II
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    CS-615 DRUG PRODUCT

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    SANKYO CO LTD
    Inactive
    13280
    N/A
    1998-10-19
    II
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    CS-622 DRUG SUBSTANCE

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    SANKYO CO LTD
    Inactive
    8645
    N/A
    1990-07-10
    II
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    CS-622 FINISHED DOSAGE FORM

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    SANKYO CO LTD
    Inactive
    8646
    N/A
    1990-07-10
    II
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    CS-780 DRUG SUBSTANCE

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    SANKYO CO LTD
    Inactive
    14202
    N/A
    1999-06-15
    II
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    • FDA
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    CS-807 CEFPODOXIME PROXETIL DRUG SU...

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    DAIICHI SANKYO PROPHA...
    Inactive
    9886
    N/A
    1987-04-15
    II
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    CS-807 TABLETS

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    SANKYO CO LTD
    Inactive
    6937
    N/A
    1987-04-15
    II
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    CS-866 DRUG PRODUCT

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    SANKYO CO LTD
    Inactive
    11432
    N/A
    1995-04-07
    II
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    CS-866 DRUG SUBSTANCE

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    SANKYO CO LTD
    Inactive
    11433
    N/A
    1995-04-07
    II
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    • FDA
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    CS-866(5 10 20 & 40MG) TABLETS

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    DAIICHI SANKYO EUROPE...
    Inactive
    14884
    N/A
    2000-05-15
    II
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    CS-866-HYDROCHLOROTHIAZIDE TABLETS ...

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    DAIICHI SANKYO EUROPE...
    Inactive
    15991
    N/A
    2002-05-31
    II
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    CS-917 DRUG PRODUCT

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    DAIICHI SANKYO CO LTD
    Inactive
    16543
    N/A
    2003-04-22
    II
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    CS-917 DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    16550
    N/A
    2003-04-28
    II
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    • FDA
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    DL-8280 CAPSULES

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    DAIICHI PHARMACEUTICA...
    Inactive
    4678
    N/A
    1982-09-28
    II
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    DL-8280, BULK FORM

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    DAIICHI PHARMACEUTICA...
    Inactive
    4665
    N/A
    1982-09-28
    II
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    • FDA
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    DR-3355 BULK SUBSTANCE

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    DAIICHI PHARMACEUTICA...
    Inactive
    8565
    N/A
    1990-05-14
    II
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    • FDA
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    DU-176B DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    17162
    N/A
    2004-02-13
    II
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    DX-9065A

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    DAIICHI PHARMACEUTICA...
    Inactive
    13182
    N/A
    1998-09-17
    II
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    EPIRIZOLE (MEBRON)

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    DAIICHI SANKYO CO LTD
    Inactive
    2684
    N/A
    1976-06-15
    II
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    • FDA
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    L-PHENYLALANINE

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    DAIICHI PURE CHEMICAL...
    Inactive
    6934
    N/A
    1987-04-02
    II
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    L-TRYPTOPHAN

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    DAIICHI PURE CHEMICAL...
    Inactive
    4960
    N/A
    1983-05-31
    II
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    L-VALINE

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    DAIICHI PURE CHEMICAL...
    Inactive
    6933
    N/A
    1987-04-02
    II
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    • FDA
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    LEVODOPA AS PRODUCED IN THE HIRATSU...

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    DAIICHI SANKYO CHEMIC...
    Inactive
    5044
    N/A
    1983-08-09
    II
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    LEVOFLOXACIN DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    10102
    N/A
    1993-02-26
    II
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    MAAA-1162A

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    DAIICHI SANKYO CO LTD
    Active
    30003
    N/A
    2015-12-09
    II
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    MAAA-1162A (COMMERCIAL)

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    DAIICHI SANKYO CO LTD
    Active
    34021
    N/A
    2019-07-31
    II
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    MALOTILATE 200 MG TABLETS

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    DAIICHI SANKYO CO LTD
    Inactive
    5347
    N/A
    1984-05-03
    II
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    • FDA
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    METHIONINE-ENKEPHALIN

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    DAIICHI PURE CHEMICAL...
    Inactive
    6719
    N/A
    1986-12-08
    II
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    METHIONINE-ENKEPHALIN AS PRODUCED I...

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    DAIICHI PURE CHEMICAL...
    Inactive
    6005
    N/A
    1985-08-06
    II
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    NIMUSTINE HCL (NIDRAN) IN VIALS

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    SANKYO CO LTD
    Inactive
    5468
    N/A
    1984-07-20
    II
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    OFLOXACIN BULK PRODUCT

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    DAIICHI SANKYO PROPHA...
    Inactive
    6351
    N/A
    1986-05-29
    II
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    • FDA
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    OLMESARTAN MEDOXOMIL DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Inactive
    14953
    N/A
    2000-07-14
    II
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    PANTETHINE BULK SUBSTANCE

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    DAIICHI PHARMACEUTICA...
    Inactive
    8887
    N/A
    1990-12-11
    II
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    • FDA
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    PRAVASTATIN SODIUM DRUG SUBSTANCE

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    DAIICHI SANKYO CO LTD
    Active
    7568
    N/A
    1988-07-11
    II
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    SUN A0026 DRUG SUBSTANCE

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    DAIICHI ASUBIO PHARMA...
    Inactive
    10570
    N/A
    1993-11-04
    II
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    SUN A0026 DRUG SUBSTANCE

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    DAIICHI ASUBIO PHARMA...
    Inactive
    14614
    N/A
    1999-12-09
    II
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    SUN11031 (HUMAN GHRELIN) DRUG SUBST...

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    DAIICHI SANKYO CO LTD
    Active
    18461
    N/A
    2005-06-30
    II
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    TRANEXAMIC ACID

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    DAIICHI SANKYO CO LTD
    Inactive
    3864
    N/A
    1980-07-10
    II
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    BULK CS-045 ORAL HYPOGLYCEMIC

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    SANKYO CO LTD
    Inactive
    9048
    N/A
    1991-04-09
    II
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    CS-003 DRUG PRODUCT

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    SANKYO CO LTD
    Inactive
    16222
    N/A
    2002-10-24
    II
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