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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Otsuka Holdings

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    01 (4-Methoxyphenyl)Methyl (6R,7R)-3-(Chloromethyl)-8-Oxo-7-(2-Phenylacetamido)-5-Thia-1-Azabicyclo[4.2.0]Oct-2-Ene-2-Carboxylate (1)

    02 2 1H-Pyridinone 5-Chloro-4-Hydroxy (1)

    03 3-2,4-Dimethoxybenzylidene-Anabaseine (1)

    04 Carteolol (1)

    05 Difamilast (1)

    06 Diindolylmethane (1)

    07 Gcle:Intermediate For Cephalosporin (1)

    08 Iodipamide (1)

    09 Iohexol (1)

    10 Lipoprotein Lipase Activator (1)

    11 Nadifloxacin (1)

    12 Procaterol (2)

    13 Rebamipide (1)

    14 Suplatast Tosilate (1)

    15 Tac 101 (1)

    16 Tazobactam Sodium (1)

    17 Tegafur (3)

    18 Tipiracil Hydrochloride (1)

    19 Trifluridine (1)

    20 Trospium Chloride (1)

    21 Water (1)

    22 Blank (9)

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    01 Active (6)

    02 Inactive (26)

    03 Blank (1)

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    01 Valid (2)

    02 Blank (31)

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    01 217MF10481 (1)

    02 225MF10181 (1)

    03 Blank (31)

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    01 Blank (33)

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      Tazobactam Sodium

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      USDMF

      Found USDMF

      31398
      Active
      TAZOBACTAM
      2017-08-30
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      217MF10481
      Tazobactam "Otsuka" at 3-2-27 Ote-d...
      2005-09-06
      Written Confirmation

      Close WC

      Application Number
      31398
      217MF10481
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Filing Details
      TAZOBACTAM
      Tazobactam "Otsuka" at 3-2-27 Ote-d...
      Issue/Submission Date
      2017-08-30
      2005-09-06
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      Iohexol

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      USDMF

      Caution USDMF

      26641
      Inactive
      IOHEXOL DRUG SUBSTANCE, FOR ORAL PR...
      2013-01-24
      CEP/COS

      Found CEP/COS

      R1-CEP 2000-018 - Rev 02
      Valid
      Iohexol
      2014-09-02
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      26641
      R1-CEP 2000-018 - Rev 02
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      IOHEXOL DRUG SUBSTANCE, FOR ORAL PR...
      Iohexol
      Issue/Submission Date
      2013-01-24
      2014-09-02
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      Trospium Chloride

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      USDMF

      Caution USDMF

      21171
      Inactive
      Trospium Chloride
      2007-10-10
      CEP/COS

      Found CEP/COS

      R1-CEP 2007-272 - Rev 00
      Valid
      Trospium chloride
      2016-02-15
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      21171
      R1-CEP 2007-272 - Rev 00
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      Trospium Chloride
      Trospium chloride
      Issue/Submission Date
      2007-10-10
      2016-02-15
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        (4-Methoxyphenyl)Methyl (6R,7R)-3-(Chloromethyl)-8-Oxo-...

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        USDMF

        Found USDMF

        22722
        Active
        P-METHOXYBENZYL (6R,7R)-3-CHLOROMET...
        2009-04-13
        CEP/COS

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        Japanese DMF

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        Written Confirmation

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        Application Number
        22722
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        P-METHOXYBENZYL (6R,7R)-3-CHLOROMET...
        Issue/Submission Date
        2009-04-13
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        Difamilast

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        USDMF

        Found USDMF

        30529
        Active
        OPA-15406 DRUG SUBSTANCE
        2016-05-23
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

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        Application Number
        30529
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        OPA-15406 DRUG SUBSTANCE
        Issue/Submission Date
        2016-05-23
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        Diindolylmethane

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        USDMF

        Found USDMF

        16998
        Active
        DIINDOLYLMETHANE DRUG SUBSTANCE
        2003-12-01
        CEP/COS

        Close CEP/COS

        Japanese DMF

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        Written Confirmation

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        Application Number
        16998
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        DIINDOLYLMETHANE DRUG SUBSTANCE
        Issue/Submission Date
        2003-12-01
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          Tipiracil Hydrochloride

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          USDMF

          Found USDMF

          28368
          Active
          TIPIRACIL HYDROCHLORIDE (TPI)
          2014-11-25
          CEP/COS

          Close CEP/COS

          Japanese DMF

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          Written Confirmation

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          Application Number
          28368
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          TIPIRACIL HYDROCHLORIDE (TPI)
          Issue/Submission Date
          2014-11-25
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            Trifluridine

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            USDMF

            Found USDMF

            34596
            Active
            TRIFLURIDINE DRUG SUBSTANCE
            2020-03-16
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            34596
            Status
            Active
            Fees Unpaid
            N/A
             
            Filing Details
            TRIFLURIDINE DRUG SUBSTANCE
            Issue/Submission Date
            2020-03-16
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            Oranekishijin hydrochloride hydrate

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            USDMF

            Close USDMF

            CEP/COS

            Close CEP/COS

            Japanese DMF

            Found JDMF

            225MF10181
            Oranekishijin hydrochloride hydrate...
            2013-09-18
            Written Confirmation

            Close WC

            Application Number
            225MF10181
            Status
             
            Filing Details
            Oranekishijin hydrochloride hydrate...
            Issue/Submission Date
            2013-09-18
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              2 1H-Pyridinone 5-Chloro-4-Hydroxy

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              USDMF

              Caution USDMF

              12554
              Inactive
              CDHP
              1997-06-18
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

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              Application Number
              12554
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              CDHP
              Issue/Submission Date
              1997-06-18
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