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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Choongwae Pharma Corporation

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    01 Cefmetazole Sodium (1)

    02 Cilastatin (1)

    03 Cilastatin Sodium (1)

    04 Imipenem (1)

    05 Itraconazole (1)

    06 Ketoconazole (1)

    07 Olanzapine (1)

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    01 Active (2)

    02 Blank (5)

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    01 Expired (2)

    02 Blank (5)

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    01 218MF10470 (1)

    02 219MF10001 (1)

    03 219MF10002 (1)

    04 220MF10186 (1)

    05 227MF10030 (1)

    06 Blank (2)

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    01 Blank (7)

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      Imipenem

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      USDMF

      Found USDMF

      23194
      Active
      PNB-THIENAMYCIN IMINE
      2009-10-19
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      219MF10002
      Imipenem hydrate at 2477, Nambusunh...
      2007-01-18
      Written Confirmation

      Close WC

      Application Number
      23194
      219MF10002
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      PNB-THIENAMYCIN IMINE
      Imipenem hydrate at 2477, Nambusunh...
      Issue/Submission Date
      2009-10-19
      2007-01-18
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        Itraconazole

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        USDMF

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        CEP/COS

        Caution CEP/COS

        R0-CEP 2003-039 - Rev 00
        Expired
        Itraconazole
        2004-10-12
        Japanese DMF

        Found JDMF

        218MF10470
        Itraconazole at 2477, Nambusunhwan-...
        2006-04-27
        Written Confirmation

        Close WC

        Application Number
        R0-CEP 2003-039 - Rev 00
        218MF10470
        Status
        Expired
         
        Filing Details
        Itraconazole
        Itraconazole at 2477, Nambusunhwan-...
        Issue/Submission Date
        2004-10-12
        2006-04-27
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          Cefmetazole Sodium

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          USDMF

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          CEP/COS

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          Japanese DMF

          Found JDMF

          220MF10186
          Cefmetazole sodium at 2477, Nambusu...
          2008-07-31
          Written Confirmation

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          Application Number
          220MF10186
          Status
           
          Filing Details
          Cefmetazole sodium at 2477, Nambusu...
          Issue/Submission Date
          2008-07-31
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            Cilastatin

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            USDMF

            Found USDMF

            23181
            Active
            CILASTATIN ACID
            2009-10-15
            CEP/COS

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            Japanese DMF

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            Written Confirmation

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            Application Number
            23181
            Status
            Active
            Fees Unpaid
            N/A
             
            Filing Details
            CILASTATIN ACID
            Issue/Submission Date
            2009-10-15
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              Cilastatin Sodium

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              USDMF

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              CEP/COS

              Close CEP/COS

              Japanese DMF

              Found JDMF

              219MF10001
              Cilastatin sodium at 2477, Nambusun...
              2007-01-18
              Written Confirmation

              Close WC

              Application Number
              219MF10001
              Status
               
              Filing Details
              Cilastatin sodium at 2477, Nambusun...
              Issue/Submission Date
              2007-01-18
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                Olanzapine

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                USDMF

                Close USDMF

                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                227MF10030
                Olanzapine at 2477, Nambusunhwan-ro...
                2015-01-23
                Written Confirmation

                Close WC

                Application Number
                227MF10030
                Status
                 
                Filing Details
                Olanzapine at 2477, Nambusunhwan-ro...
                Issue/Submission Date
                2015-01-23
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                  Ketoconazole

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                  USDMF

                  Close USDMF

                  CEP/COS

                  Caution CEP/COS

                  R0-CEP 2000-287 - Rev 02
                  Expired
                  Ketoconazole
                  2004-10-20
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  R0-CEP 2000-287 - Rev 02
                  Status
                  Expired
                   
                  Filing Details
                  Ketoconazole
                  Issue/Submission Date
                  2004-10-20
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