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

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    01 CARTEOLOL HCL (1)

    02 CDHP (1)

    03 COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TOKUSHIMA, JAPAN (1)

    04 DIINDOLYLMETHANE DRUG SUBSTANCE (1)

    05 FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY, JAPAN (1)

    06 FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN (1)

    07 FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR) (1)

    08 GTS-21 (1)

    09 IODIPAMIDE DRUG SUBSTANCE (1)

    10 IOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS (1)

    11 IPD-1151T DRUG SUBSTANCE (1)

    12 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN. (3)

    13 NADIFLOXACIN DRUG SUBSTANCE (1)

    14 NO-1886 DRUG SUBSTANCE (1)

    15 OPA-15406 DRUG SUBSTANCE (1)

    16 P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCE (1)

    17 P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE (1)

    18 PROCATEROL HYDROCHLORIDE HEMIHYDRATE (1)

    19 PROCATEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY (1)

    20 REBAMIPIDE(OPC-12759) DRUG SUBSTANCE (1)

    21 STERILE WATER FOR INJECTION USP, 2 ML VIAL (1)

    22 TAC-101 DRUG SUBSTANCE (1)

    23 TAS-103 (1)

    24 TAZOBACTAM (1)

    25 TEGAFUR (1)

    26 TIPIRACIL HYDROCHLORIDE (TPI) (1)

    27 TRIFLURIDINE DRUG SUBSTANCE (1)

    28 Trospium Chloride (1)

    29 UFT CAPSULES (TEGAFUR AND URACIL) (1)

    30 WM-1-DAITO INTERMEDIATE FOR CDHP (1)

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    01 INTERPHARMA PRAHA AS (4)

    02 OTSUKA AMERICA PHARMACEUTICAL INC (1)

    03 OTSUKA CHEMICAL CO LTD (2)

    04 OTSUKA CHEMICAL INDIA PRIVATE LTD (1)

    05 OTSUKA PHARMACEUTICAL CO LTD (13)

    06 TAIHO PHARMACEUTICAL CO INC (2)

    07 TAIHO PHARMACEUTICAL CO LTD (9)

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    02 Japan (28)

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    02 Inactive (26)

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      CARTEOLOL HCL

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      OTSUKA PHARMACEUTICAL...
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      2671
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      1976-05-13
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        CDHP

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        TAIHO PHARMACEUTICAL ...
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        12554
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        1997-06-18
        II
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        DIINDOLYLMETHANE DRUG SUBSTANCE

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        INTERPHARMA PRAHA AS
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        16998
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        2003-12-01
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          FTORAFUR (ALSO CALLED FUTRAFUL OR T...

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          TAIHO PHARMACEUTICAL ...
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          4235
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          1981-08-05
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            GTS-21

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            TAIHO PHARMACEUTICAL ...
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            14645
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            1999-12-28
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            IODIPAMIDE DRUG SUBSTANCE

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            INTERPHARMA PRAHA AS
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            10576
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            1993-11-18
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            IOHEXOL DRUG SUBSTANCE, FOR ORAL PR...

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            INTERPHARMA PRAHA AS
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            26641
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            2013-01-24
            II
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              IPD-1151T DRUG SUBSTANCE

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              TAIHO PHARMACEUTICAL ...
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              17336
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              2004-04-12
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                NADIFLOXACIN DRUG SUBSTANCE

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                OTSUKA PHARMACEUTICAL...
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                12418
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                1997-03-01
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                  NO-1886 DRUG SUBSTANCE

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                  OTSUKA PHARMACEUTICAL...
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                  13285
                  N/A
                  1998-10-15
                  II
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