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

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    01 Aciclovir (1)

    02 Adefovir Dipivoxil (1)

    03 Carisoprodol (1)

    04 Clopidogrel (4)

    05 Clopidogrel Besylate (1)

    06 Famciclovir (1)

    07 Ganciclovir (1)

    08 Irinotecan Hydrochloride (1)

    09 Naproxen (1)

    10 Naproxen Sodium (2)

    11 Penciclovir (1)

    12 Rivaroxaban (1)

    13 Valacyclovir Hydrochloride (3)

    14 Valganciclovir Hydrochloride (3)

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    01 Active (12)

    02 Inactive (7)

    03 Blank (3)

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    01 Valid (9)

    02 Withdrawn by Holder (1)

    03 Blank (12)

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    01 218MF10098 (1)

    02 Blank (21)

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    01 Blank (22)

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      Aciclovir

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      USDMF

      Found USDMF

      20203
      Active
      ACYCLOVIR USP (API)
      2007-01-12
      CEP/COS

      Found CEP/COS

      CEP 2001-283 - Rev 06
      Valid
      Aciclovir
      2023-11-29
      Japanese DMF

      Found JDMF

      218MF10098
      Acyclovir at Tongyuanxi, Dazhan, Xi...
      2006-01-30
      Written Confirmation

      Close WC

      Application Number
      20203
      CEP 2001-283 - Rev 06
      218MF10098
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      ACYCLOVIR USP (API)
      Aciclovir
      Acyclovir at Tongyuanxi, Dazhan, Xi...
      Issue/Submission Date
      2007-01-12
      2023-11-29
      2006-01-30
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        Clopidogrel

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        USDMF

        Found USDMF

        29529
        Active
        CLOPIDOGREL BISULFATE USP
        2015-06-29
        CEP/COS

        Found CEP/COS

        R0-CEP 2022-063 - Rev 00
        Valid
        Clopidogrel hydrogen sulfate, Proce...
        2022-07-27
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        29529
        R0-CEP 2022-063 - Rev 00
        Status
        Active
        Fees Paid
        N/A
        Valid
         
        Filing Details
        CLOPIDOGREL BISULFATE USP
        Clopidogrel hydrogen sulfate, Proce...
        Issue/Submission Date
        2015-06-29
        2022-07-27
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          Ganciclovir

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          USDMF

          Found USDMF

          27133
          Active
          GANCICLOVIR USP (NON-STERILE API)
          2013-05-02
          CEP/COS

          Found CEP/COS

          R1-CEP 2013-123 - Rev 01
          Valid
          Ganciclovir
          2019-06-20
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          27133
          R1-CEP 2013-123 - Rev 01
          Status
          Active
          Fees Paid
          N/A
          Valid
           
          Filing Details
          GANCICLOVIR USP (NON-STERILE API)
          Ganciclovir
          Issue/Submission Date
          2013-05-02
          2019-06-20
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            Naproxen

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            USDMF

            Found USDMF

            18554
            Active
            NAPROXEN USP (BULK)
            2005-07-25
            CEP/COS

            Found CEP/COS

            R1-CEP 2006-270 - Rev 02
            Valid
            Naproxen
            2018-03-12
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            18554
            R1-CEP 2006-270 - Rev 02
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Filing Details
            NAPROXEN USP (BULK)
            Naproxen
            Issue/Submission Date
            2005-07-25
            2018-03-12
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              Naproxen Sodium

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              USDMF

              Found USDMF

              13243
              Active
              NAPROXEN SODIUM, USP (BULK)
              1998-10-01
              CEP/COS

              Found CEP/COS

              R1-CEP 2010-021 - Rev 01
              Valid
              Naproxen sodium
              2018-02-22
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              13243
              R1-CEP 2010-021 - Rev 01
              Status
              Active
              Fees Paid
              Reviewed
              Valid
               
              Filing Details
              NAPROXEN SODIUM, USP (BULK)
              Naproxen sodium
              Issue/Submission Date
              1998-10-01
              2018-02-22
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                Clopidogrel

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                USDMF

                Caution USDMF

                29388
                Inactive
                CLOPIDOGREL INTERMEDIATE P4
                2015-05-11
                CEP/COS

                Found CEP/COS

                R1-CEP 2014-240 - Rev 00
                Valid
                Clopidogrel hydrogen sulfate, Form ...
                2020-01-16
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                29388
                R1-CEP 2014-240 - Rev 00
                Status
                Inactive
                Fees Paid
                N/A
                Valid
                 
                Filing Details
                CLOPIDOGREL INTERMEDIATE P4
                Clopidogrel hydrogen sulfate, Form ...
                Issue/Submission Date
                2015-05-11
                2020-01-16
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                  Valacyclovir Hydrochloride

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                  USDMF

                  Caution USDMF

                  24694
                  Inactive
                  VALACYCLOVIR HYDROCHLORIDE
                  2011-02-25
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2013-180 - Rev 00
                  Valid
                  Valaciclovir hydrochloride, Form II
                  2020-01-09
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  24694
                  R1-CEP 2013-180 - Rev 00
                  Status
                  Inactive
                  Fees Paid
                  N/A
                  Valid
                   
                  Filing Details
                  VALACYCLOVIR HYDROCHLORIDE
                  Valaciclovir hydrochloride, Form II
                  Issue/Submission Date
                  2011-02-25
                  2020-01-09
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                    Adefovir Dipivoxil

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                    USDMF

                    Found USDMF

                    24151
                    Active
                    ADEFOVIR DIPIVOXIL DMC (ADVANCE INT...
                    2010-08-28
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    24151
                    Status
                    Active
                    Fees Paid
                    N/A
                     
                    Filing Details
                    ADEFOVIR DIPIVOXIL DMC (ADVANCE INT...
                    Issue/Submission Date
                    2010-08-28
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                      Clopidogrel

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                      USDMF

                      Close USDMF

                      CEP/COS

                      Found CEP/COS

                      R0-CEP 2022-057 - Rev 00
                      Valid
                      Clopidogrel hydrogen sulfate, Form ...
                      2022-08-08
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      R0-CEP 2022-057 - Rev 00
                      Status
                      Valid
                       
                      Filing Details
                      Clopidogrel hydrogen sulfate, Form ...
                      Issue/Submission Date
                      2022-08-08
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                        Clopidogrel Besylate

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Found CEP/COS

                        R1-CEP 2017-230 - Rev 00
                        Valid
                        Clopidogrel besilate
                        2023-07-04
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        R1-CEP 2017-230 - Rev 00
                        Status
                        Valid
                         
                        Filing Details
                        Clopidogrel besilate
                        Issue/Submission Date
                        2023-07-04
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