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

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    01 CARTEOLOL HCL (1)

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

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

    04 FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN (1)

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

    06 NADIFLOXACIN DRUG SUBSTANCE (1)

    07 NO-1886 DRUG SUBSTANCE (1)

    08 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)

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

    10 PROCATEROL HYDROCHLORIDE HEMIHYDRATE (1)

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

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

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

    14 TAZOBACTAM (1)

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    01 OTSUKA AMERICA PHARMACEUTICAL INC (1)

    02 OTSUKA CHEMICAL CO LTD (2)

    03 OTSUKA CHEMICAL INDIA PRIVATE LTD (1)

    04 OTSUKA PHARMACEUTICAL CO LTD (12)

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    01 Japan (16)

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    01 Active (2)

    02 Inactive (14)

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    01 Complete (1)

    02 Blank (15)

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      CARTEOLOL HCL

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      OTSUKA PHARMACEUTICAL...
      Inactive
      2671
      N/A
      1976-05-13
      II
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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
        II
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          NO-1886 DRUG SUBSTANCE

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          OTSUKA PHARMACEUTICAL...
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          13285
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          1998-10-15
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            P-METHOXYBENZYL (6R,7R)-3-CHLOROMET...

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            OTSUKA CHEMICAL INDIA...
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            22722
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            2009-04-13
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              P-METHOXYBENZYL(6R,7R)-3-CHLOROMETH...

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              OTSUKA CHEMICAL CO LT...
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              20451
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              2007-04-10
              II
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                PROCATEROL HYDROCHLORIDE HEMIHYDRAT...

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                OTSUKA PHARMACEUTICAL...
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                3606
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                1979-09-19
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                  PROCATEROL, AEROSOL FORMULATION PRO...

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                  OTSUKA PHARMACEUTICAL...
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                  4820
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                  1983-01-17
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                    REBAMIPIDE(OPC-12759) DRUG SUBSTANC...

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                    OTSUKA PHARMACEUTICAL...
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                    15001
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                    2000-08-10
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                      STERILE WATER FOR INJECTION USP, 2 ...

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                      OTSUKA AMERICA PHARMA...
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                      2011-09-19
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                        TAZOBACTAM

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                        OTSUKA CHEMICAL CO LT...
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                        2018-03-20
                        2017-08-28
                        2017-08-30
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