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

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    Otsuka Holdings
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    Japan
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    2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo 101-0048
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    +81 (0)3-6717-1410
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    enquiries@pharmacompass.com
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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

      Close WC

      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

      Close WC

      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

        Close CEP/COS

        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

              Close WC

              Application Number
              12554
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              CDHP
              Issue/Submission Date
              1997-06-18
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                3-2,4-Dimethoxybenzylidene-Anabaseine

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                USDMF

                Caution USDMF

                14645
                Inactive
                GTS-21
                1999-12-28
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                14645
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                GTS-21
                Issue/Submission Date
                1999-12-28
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                  Carteolol

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                  USDMF

                  Caution USDMF

                  2671
                  Inactive
                  CARTEOLOL HCL
                  1976-05-13
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  2671
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  CARTEOLOL HCL
                  Issue/Submission Date
                  1976-05-13
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                    Gcle:Intermediate For Cephalosporin

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                    USDMF

                    Caution USDMF

                    20451
                    Inactive
                    P-METHOXYBENZYL(6R,7R)-3-CHLOROMETH...
                    2007-04-10
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    20451
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    P-METHOXYBENZYL(6R,7R)-3-CHLOROMETH...
                    Issue/Submission Date
                    2007-04-10
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                    Iodipamide

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                    USDMF

                    Caution USDMF

                    10576
                    Inactive
                    IODIPAMIDE DRUG SUBSTANCE
                    1993-11-18
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    10576
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    IODIPAMIDE DRUG SUBSTANCE
                    Issue/Submission Date
                    1993-11-18
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                      Lipoprotein Lipase Activator

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                      USDMF

                      Caution USDMF

                      13285
                      Inactive
                      NO-1886 DRUG SUBSTANCE
                      1998-10-15
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      13285
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      NO-1886 DRUG SUBSTANCE
                      Issue/Submission Date
                      1998-10-15
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                        Nadifloxacin

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                        USDMF

                        Caution USDMF

                        12418
                        Inactive
                        NADIFLOXACIN DRUG SUBSTANCE
                        1997-03-01
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        12418
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        NADIFLOXACIN DRUG SUBSTANCE
                        Issue/Submission Date
                        1997-03-01
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                          Procaterol

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                          USDMF

                          Caution USDMF

                          3606
                          Inactive
                          PROCATEROL HYDROCHLORIDE HEMIHYDRAT...
                          1979-09-19
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          3606
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                           
                          Filing Details
                          PROCATEROL HYDROCHLORIDE HEMIHYDRAT...
                          Issue/Submission Date
                          1979-09-19
                          ASK
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                            Procaterol

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                            USDMF

                            Caution USDMF

                            4820
                            Inactive
                            PROCATEROL, AEROSOL FORMULATION PRO...
                            1983-01-17
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            4820
                            Status
                            Inactive
                            Fees Unpaid
                            N/A
                             
                            Filing Details
                            PROCATEROL, AEROSOL FORMULATION PRO...
                            Issue/Submission Date
                            1983-01-17
                            ASK
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                              Rebamipide

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                              USDMF

                              Caution USDMF

                              15001
                              Inactive
                              REBAMIPIDE(OPC-12759) DRUG SUBSTANC...
                              2000-08-10
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              15001
                              Status
                              Inactive
                              Fees Unpaid
                              N/A
                               
                              Filing Details
                              REBAMIPIDE(OPC-12759) DRUG SUBSTANC...
                              Issue/Submission Date
                              2000-08-10
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                                Suplatast Tosilate

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                                USDMF

                                Caution USDMF

                                17336
                                Inactive
                                IPD-1151T DRUG SUBSTANCE
                                2004-04-12
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                17336
                                Status
                                Inactive
                                Fees Unpaid
                                N/A
                                 
                                Filing Details
                                IPD-1151T DRUG SUBSTANCE
                                Issue/Submission Date
                                2004-04-12
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                                  Tac 101

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                                  USDMF

                                  Caution USDMF

                                  21314
                                  Inactive
                                  TAC-101 DRUG SUBSTANCE
                                  2008-02-06
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  21314
                                  Status
                                  Inactive
                                  Fees Unpaid
                                  N/A
                                   
                                  Filing Details
                                  TAC-101 DRUG SUBSTANCE
                                  Issue/Submission Date
                                  2008-02-06
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                                    Tegafur

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                                    USDMF

                                    Caution USDMF

                                    4235
                                    Inactive
                                    FTORAFUR (ALSO CALLED FUTRAFUL OR T...
                                    1981-08-05
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    4235
                                    Status
                                    Inactive
                                    Fees Unpaid
                                    N/A
                                     
                                    Filing Details
                                    FTORAFUR (ALSO CALLED FUTRAFUL OR T...
                                    Issue/Submission Date
                                    1981-08-05
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                                      Tegafur

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                                      USDMF

                                      Caution USDMF

                                      10396
                                      Inactive
                                      TEGAFUR
                                      1993-06-17
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      10396
                                      Status
                                      Inactive
                                      Fees Unpaid
                                      N/A
                                       
                                      Filing Details
                                      TEGAFUR
                                      Issue/Submission Date
                                      1993-06-17
                                      ASK
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                                        Tegafur

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                                        USDMF

                                        Caution USDMF

                                        10400
                                        Inactive
                                        UFT CAPSULES (TEGAFUR AND URACIL)
                                        1993-06-17
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        10400
                                        Status
                                        Inactive
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        UFT CAPSULES (TEGAFUR AND URACIL)
                                        Issue/Submission Date
                                        1993-06-17
                                        ASK
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                                          Water

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                                          USDMF

                                          Caution USDMF

                                          25240
                                          Inactive
                                          STERILE WATER FOR INJECTION USP, 2 ...
                                          2011-09-19
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          25240
                                          Status
                                          Inactive
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          STERILE WATER FOR INJECTION USP, 2 ...
                                          Issue/Submission Date
                                          2011-09-19
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                                            TAS-103

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                                            USDMF

                                            Caution USDMF

                                            11983
                                            Inactive
                                            TAS-103
                                            1996-05-31
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            11983
                                            Status
                                            Inactive
                                            Fees Unpaid
                                            N/A
                                             
                                            Filing Details
                                            TAS-103
                                            Issue/Submission Date
                                            1996-05-31
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                                              WM-1-DAITO INTERMEDIATE FOR CDHP

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                                              USDMF

                                              Caution USDMF

                                              20637
                                              Inactive
                                              WM-1-DAITO INTERMEDIATE FOR CDHP
                                              2007-06-27
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              20637
                                              Status
                                              Inactive
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              WM-1-DAITO INTERMEDIATE FOR CDHP
                                              Issue/Submission Date
                                              2007-06-27
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                                                MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                                                USDMF

                                                Caution USDMF

                                                6085
                                                Inactive
                                                MANUFACTURING SITE, FACILITIES, PER...
                                                1985-11-07
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                6085
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                 
                                                Filing Details
                                                MANUFACTURING SITE, FACILITIES, PER...
                                                Issue/Submission Date
                                                1985-11-07
                                                ASK
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                                                  MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                                                  USDMF

                                                  Caution USDMF

                                                  6091
                                                  Inactive
                                                  MANUFACTURING SITE, FACILITIES, PER...
                                                  1985-11-07
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  6091
                                                  Status
                                                  Inactive
                                                  Fees Unpaid
                                                  N/A
                                                   
                                                  Filing Details
                                                  MANUFACTURING SITE, FACILITIES, PER...
                                                  Issue/Submission Date
                                                  1985-11-07
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                                                    USDMF

                                                    Caution USDMF

                                                    9534
                                                    Inactive
                                                    MANUFACTURING SITE, FACILITIES, PER...
                                                    1992-01-10
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    9534
                                                    Status
                                                    Inactive
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Filing Details
                                                    MANUFACTURING SITE, FACILITIES, PER...
                                                    Issue/Submission Date
                                                    1992-01-10
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                                                      FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY...

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                                                      USDMF

                                                      Caution USDMF

                                                      9894
                                                      Inactive
                                                      FACILITIES AND OPERATING PROCEDURES...
                                                      1992-08-21
                                                      CEP/COS

                                                      Close CEP/COS

                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Close WC

                                                      Application Number
                                                      9894
                                                      Status
                                                      Inactive
                                                      Fees Unpaid
                                                      N/A
                                                       
                                                      Filing Details
                                                      FACILITIES AND OPERATING PROCEDURES...
                                                      Issue/Submission Date
                                                      1992-08-21
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                                                        COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TO...

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                                                        USDMF

                                                        Caution USDMF

                                                        9896
                                                        Inactive
                                                        COMMERCIAL BULK PLANT OF SECOND TOK...
                                                        1992-10-05
                                                        CEP/COS

                                                        Close CEP/COS

                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Close WC

                                                        Application Number
                                                        9896
                                                        Status
                                                        Inactive
                                                        Fees Unpaid
                                                        N/A
                                                         
                                                        Filing Details
                                                        COMMERCIAL BULK PLANT OF SECOND TOK...
                                                        Issue/Submission Date
                                                        1992-10-05
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                                                          FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN

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                                                          USDMF

                                                          Caution USDMF

                                                          10257
                                                          Inactive
                                                          FORMULATION RESEARCH INSTITUTE IN T...
                                                          1993-05-20
                                                          CEP/COS

                                                          Close CEP/COS

                                                          Japanese DMF

                                                          Close JDMF

                                                          Written Confirmation

                                                          Close WC

                                                          Application Number
                                                          10257
                                                          Status
                                                          Inactive
                                                          Fees Unpaid
                                                          N/A
                                                           
                                                          Filing Details
                                                          FORMULATION RESEARCH INSTITUTE IN T...
                                                          Issue/Submission Date
                                                          1993-05-20
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