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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Roche Diagnostics Gmbh

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    01 137309-88-7 (1)

    02 Adenosine (1)

    03 Alpha-D-Galactose (1)

    04 Aminophylline (2)

    05 Benzylamine (1)

    06 Carvedilol (1)

    07 Catalase (1)

    08 Cytarabine (1)

    09 D-Phenylalanine API (1)

    10 Deoxyuridine (1)

    11 Digitoxin (1)

    12 Digoxin (1)

    13 Doxepin (1)

    14 Doxepin Hydrochloride (1)

    15 Ibandronate Sodium (1)

    16 Idoxuridine (1)

    17 Metaxalone (1)

    18 Methyldopa (1)

    19 Methyldopate Hydrochloride (1)

    20 Metipranolol HCl (1)

    21 N-Decylmethyl Sulfoxide (1)

    22 Nitrofurantoin (1)

    23 Oxtriphylline (1)

    24 Propranolol Hydrochloride (1)

    25 Propylthiouracil (1)

    26 Quatrimycin Hydrochloride (1)

    27 Quinidine Gluconate (1)

    28 Quinine Sulfate (1)

    29 Spironolactone (1)

    30 Sulfadoxine (1)

    31 Tetracycline Hydrochloride (1)

    32 Theophylline (1)

    33 Torsemide (1)

    34 Blank (8)

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    01 Inactive (40)

    02 Blank (2)

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    01 Valid (2)

    02 Withdrawn by Holder (2)

    03 Blank (38)

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    01 Blank (42)

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    01 Blank (42)

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      Digoxin

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      USDMF

      Caution USDMF

      2277
      Inactive
      DIGOXIN PRODUCTS
      1974-05-17
      CEP/COS

      Found CEP/COS

      R1-CEP 1996-048 - Rev 02
      Valid
      Digoxin
      2006-11-10
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      2277
      R1-CEP 1996-048 - Rev 02
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      DIGOXIN PRODUCTS
      Digoxin
      Issue/Submission Date
      1974-05-17
      2006-11-10
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        Alpha-D-Galactose

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        USDMF

        Caution USDMF

        8650
        Inactive
        GALACTOSE, THERAPEUTIC GRADE
        1990-07-03
        CEP/COS

        Caution CEP/COS

        R1-CEP 1997-098 - Rev 02
        Withdrawn by Holder
        Galactose
        2010-12-01
        Japanese DMF

        Close JDMF

        Written Confirmation

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        Application Number
        8650
        R1-CEP 1997-098 - Rev 02
        Status
        Inactive
        Fees Unpaid
        N/A
        Withdrawn by Holder
         
        Filing Details
        GALACTOSE, THERAPEUTIC GRADE
        Galactose
        Issue/Submission Date
        1990-07-03
        2010-12-01
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          Doxepin Hydrochloride

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          USDMF

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          CEP/COS

          Found CEP/COS

          R1-CEP 1999-094 - Rev 01
          Valid
          Doxepin hydrochloride
          2008-07-21
          Japanese DMF

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          Application Number
          R1-CEP 1999-094 - Rev 01
          Status
          Valid
           
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          Doxepin hydrochloride
          Issue/Submission Date
          2008-07-21
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            137309-88-7

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            USDMF

            Caution USDMF

            9532
            Inactive
            GUAIACOL-O-ETHYLTOSYLATE
            1992-02-06
            CEP/COS

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            Japanese DMF

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            Written Confirmation

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            Application Number
            9532
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            GUAIACOL-O-ETHYLTOSYLATE
            Issue/Submission Date
            1992-02-06
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              Adenosine

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              USDMF

              Caution USDMF

              8225
              Inactive
              ADENOSINE DEAMINASE THERAPEUTIC GRA...
              1989-09-21
              CEP/COS

              Close CEP/COS

              Japanese DMF

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              Written Confirmation

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              Application Number
              8225
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              ADENOSINE DEAMINASE THERAPEUTIC GRA...
              Issue/Submission Date
              1989-09-21
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                Aminophylline

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                USDMF

                Caution USDMF

                3962
                Inactive
                AMINOPHYLLINE,ANHYDROUS(THEOPHYLLIN...
                1980-09-25
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                3962
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                AMINOPHYLLINE,ANHYDROUS(THEOPHYLLIN...
                Issue/Submission Date
                1980-09-25
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                  Aminophylline

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                  USDMF

                  Caution USDMF

                  3966
                  Inactive
                  AMINOPHYLLINE, HYDROUS (THEOPHYLLIN...
                  1980-09-26
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  3966
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  AMINOPHYLLINE, HYDROUS (THEOPHYLLIN...
                  Issue/Submission Date
                  1980-09-26
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                    Benzylamine

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                    USDMF

                    Caution USDMF

                    17043
                    Inactive
                    GUAIACOL-O-ETHYLBENZYLAMINE HCL
                    2003-12-16
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

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                    Application Number
                    17043
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    GUAIACOL-O-ETHYLBENZYLAMINE HCL
                    Issue/Submission Date
                    2003-12-16
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                      Carvedilol

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                      USDMF

                      Caution USDMF

                      20587
                      Inactive
                      CARVEDILOL
                      2007-06-05
                      CEP/COS

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                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      20587
                      Status
                      Inactive
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      CARVEDILOL
                      Issue/Submission Date
                      2007-06-05
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                        Catalase

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                        USDMF

                        Caution USDMF

                        8106
                        Inactive
                        CATALASE THERAPEUTIC GRADE
                        1989-06-12
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

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                        Application Number
                        8106
                        Status
                        Inactive
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        CATALASE THERAPEUTIC GRADE
                        Issue/Submission Date
                        1989-06-12
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