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

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    01 Amifostine (1)

    02 Aminohippuric Acid (1)

    03 Benazepril Hydrochloride (1)

    04 Benzonatate (1)

    05 CAS 150975-95-4 (1)

    06 Diphenhydramine Citrate (1)

    07 Fenoprofen Calcium (1)

    08 Flurbiprofen (1)

    09 Itraconazole (1)

    10 Lidocaine (2)

    11 Lidocaine Hydrochloride (1)

    12 Linezolid (1)

    13 Meclofenamic Acid (1)

    14 Milrinone (1)

    15 Orphenadrine (1)

    16 Pramoxine Hydrochloride (1)

    17 Procainamide Hydrochloride (1)

    18 Propranolol Hydrochloride (1)

    19 Terconazole (1)

    20 Tetracaine Hydrochloride (1)

    filter

    01 Active (17)

    02 Inactive (3)

    03 Blank (1)

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    01 Valid (2)

    02 Blank (19)

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    01 Blank (21)

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    01 Blank (21)

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      Itraconazole

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      USDMF

      Found USDMF

      12697
      Active
      ITRACONAZOLE USP & PH EUR
      1997-10-16
      CEP/COS

      Found CEP/COS

      R1-CEP 1999-196 - Rev 04
      Valid
      Itraconazole
      2021-07-29
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      12697
      R1-CEP 1999-196 - Rev 04
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      ITRACONAZOLE USP & PH EUR
      Itraconazole
      Issue/Submission Date
      1997-10-16
      2021-07-29
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        Amifostine

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        USDMF

        Found USDMF

        22909
        Active
        AMIFOSTINE
        2009-06-26
        CEP/COS

        Close CEP/COS

        Japanese DMF

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        Written Confirmation

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        Application Number
        22909
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        AMIFOSTINE
        Issue/Submission Date
        2009-06-26
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          Benazepril Hydrochloride

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          USDMF

          Found USDMF

          14720
          Active
          BENAZEPRIL HYDROCHLORIDE
          2000-02-21
          CEP/COS

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          Japanese DMF

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          Written Confirmation

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          Application Number
          14720
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Filing Details
          BENAZEPRIL HYDROCHLORIDE
          Issue/Submission Date
          2000-02-21
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            Benzonatate

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            USDMF

            Found USDMF

            5196
            Active
            BENZONATATE USP
            1983-12-13
            CEP/COS

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            Japanese DMF

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            Written Confirmation

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            Application Number
            5196
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Filing Details
            BENZONATATE USP
            Issue/Submission Date
            1983-12-13
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              Diphenhydramine Citrate

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              USDMF

              Found USDMF

              11097
              Active
              DIPHENHYDRAMINE CITRATE, USP
              1994-09-23
              CEP/COS

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              Japanese DMF

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              Written Confirmation

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              Application Number
              11097
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              DIPHENHYDRAMINE CITRATE, USP
              Issue/Submission Date
              1994-09-23
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                Fenoprofen Calcium

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                USDMF

                Found USDMF

                6843
                Active
                FENOPROFEN CALCIUM, USP+BP
                1987-03-03
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                6843
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Filing Details
                FENOPROFEN CALCIUM, USP+BP
                Issue/Submission Date
                1987-03-03
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                  Flurbiprofen

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                  USDMF

                  Found USDMF

                  11902
                  Active
                  FLURBIPROFEN USP & BP
                  1996-03-26
                  CEP/COS

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                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  11902
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Filing Details
                  FLURBIPROFEN USP & BP
                  Issue/Submission Date
                  1996-03-26
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                    Lidocaine

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                    USDMF

                    Found USDMF

                    4323
                    Active
                    LIDOCAINE HCL, USP, BP & PH EUR
                    1981-11-10
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    4323
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                     
                    Filing Details
                    LIDOCAINE HCL, USP, BP & PH EUR
                    Issue/Submission Date
                    1981-11-10
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                      Lidocaine

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                      USDMF

                      Found USDMF

                      11564
                      Active
                      LIDOCAINE USP
                      1995-06-05
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      11564
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Filing Details
                      LIDOCAINE USP
                      Issue/Submission Date
                      1995-06-05
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                        Lidocaine Hydrochloride

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Found CEP/COS

                        R1-CEP 2010-029 - Rev 02
                        Valid
                        Lidocaine hydrochloride monohydrate
                        2021-08-02
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        R1-CEP 2010-029 - Rev 02
                        Status
                        Valid
                         
                        Filing Details
                        Lidocaine hydrochloride monohydrate
                        Issue/Submission Date
                        2021-08-02
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