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

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    01 Amoxicillin Trihydrate (1)

    02 Ampicillin (1)

    03 Cefotiam Hydrochloride (1)

    04 Ceftriaxone (1)

    05 Cefuroxime Axetil (1)

    06 Cloxacillin Sodium (1)

    07 Iopromide (1)

    08 Lansoprazole (1)

    09 Meropenem (2)

    10 Rabeprazole (2)

    11 Trimethoprim (1)

    12 Ursodeoxycholic Acid (4)

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    01 Active (2)

    02 Inactive (6)

    03 Blank (9)

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    01 Valid (5)

    02 Withdrawn by Holder (1)

    03 Blank (11)

    filter

    01 218MF10402 (1)

    02 218MF11024 (1)

    03 218MF11025 (1)

    04 219MF10378 (1)

    05 219MF10384 (1)

    06 221MF10024 (1)

    07 221MF10239 (1)

    08 226MF10088 (1)

    09 227MF10156 (1)

    10 229MF10216 (1)

    11 304MF10016 (1)

    12 305MF10072 (1)

    13 Blank (5)

    filter

    01 Blank (17)

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      Ursodeoxycholic Acid

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      USDMF

      Found USDMF

      25536
      Active
      URSODIOL USP (PROCESS I)
      2011-11-16
      CEP/COS

      Found CEP/COS

      R1-CEP 2012-157 - Rev 00
      Valid
      Ursodeoxycholic acid, Process II
      2018-06-19
      Japanese DMF

      Found JDMF

      304MF10016
      Ursodeoxocholic acid at 12, BONGEUN...
      2022-01-20
      Written Confirmation

      Close WC

      Application Number
      25536
      R1-CEP 2012-157 - Rev 00
      304MF10016
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      URSODIOL USP (PROCESS I)
      Ursodeoxycholic acid, Process II
      Ursodeoxocholic acid at 12, BONGEUN...
      Issue/Submission Date
      2011-11-16
      2018-06-19
      2022-01-20
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        Ursodeoxycholic Acid

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        USDMF

        Found USDMF

        28994
        Active
        URSODIOL USP (PROCESS IV)
        2015-02-10
        CEP/COS

        Found CEP/COS

        R0-CEP 2022-479 - Rev 00
        Valid
        Ursodeoxycholic acid, Process IV
        2023-03-31
        Japanese DMF

        Found JDMF

        227MF10156
        Ursodeoxycholic acid at 12, BONGEUN...
        2015-06-18
        Written Confirmation

        Close WC

        Application Number
        28994
        R0-CEP 2022-479 - Rev 00
        227MF10156
        Status
        Active
        Fees Unpaid
        Reviewed
        Valid
         
        Filing Details
        URSODIOL USP (PROCESS IV)
        Ursodeoxycholic acid, Process IV
        Ursodeoxycholic acid at 12, BONGEUN...
        Issue/Submission Date
        2015-02-10
        2023-03-31
        2015-06-18
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          Ursodeoxycholic Acid

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          USDMF

          Caution USDMF

          21434
          Inactive
          URSODIOL USP (URSODEOXYCHOLIC ACID)
          2008-03-17
          CEP/COS

          Found CEP/COS

          R0-CEP 2020-134 - Rev 00
          Valid
          Ursodeoxycholic acid, Process III
          2021-09-03
          Japanese DMF

          Found JDMF

          305MF10072
          Ursodeoxocholic acid at 12, BONGEUN...
          2023-06-07
          Written Confirmation

          Close WC

          Application Number
          21434
          R0-CEP 2020-134 - Rev 00
          305MF10072
          Status
          Inactive
          Fees Unpaid
          N/A
          Valid
           
          Filing Details
          URSODIOL USP (URSODEOXYCHOLIC ACID)
          Ursodeoxycholic acid, Process III
          Ursodeoxocholic acid at 12, BONGEUN...
          Issue/Submission Date
          2008-03-17
          2021-09-03
          2023-06-07
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            Ursodeoxycholic Acid

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            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R1-CEP 2011-354 - Rev 00
            Valid
            Ursodeoxycholic acid
            2018-07-30
            Japanese DMF

            Found JDMF

            226MF10088
            Ursodeoxycholic acid at 12, BONGEUN...
            2014-05-09
            Written Confirmation

            Close WC

            Application Number
            R1-CEP 2011-354 - Rev 00
            226MF10088
            Status
            Valid
             
            Filing Details
            Ursodeoxycholic acid
            Ursodeoxycholic acid at 12, BONGEUN...
            Issue/Submission Date
            2018-07-30
            2014-05-09
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              Amoxicillin Trihydrate

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              USDMF

              Caution USDMF

              13772
              Inactive
              AMOXICILLIN
              1998-09-01
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Found JDMF

              221MF10239
              Amoxicillin hydrate at 12 BONGEUNSA...
              2009-11-09
              Written Confirmation

              Close WC

              Application Number
              13772
              221MF10239
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              AMOXICILLIN
              Amoxicillin hydrate at 12 BONGEUNSA...
              Issue/Submission Date
              1998-09-01
              2009-11-09
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                Ampicillin

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                USDMF

                Close USDMF

                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                218MF11025
                [Japanese Pharmacopoeia] ampicillin...
                2006-12-28
                Written Confirmation

                Close WC

                Application Number
                218MF11025
                Status
                 
                Filing Details
                [Japanese Pharmacopoeia] ampicillin...
                Issue/Submission Date
                2006-12-28
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                  Cefotiam Hydrochloride

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                  USDMF

                  Close USDMF

                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Found JDMF

                  219MF10384
                  Cefotiam hydrochloride at 163-3, SA...
                  2007-12-19
                  Written Confirmation

                  Close WC

                  Application Number
                  219MF10384
                  Status
                   
                  Filing Details
                  Cefotiam hydrochloride at 163-3, SA...
                  Issue/Submission Date
                  2007-12-19
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                    Ceftriaxone

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                    USDMF

                    Close USDMF

                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Found JDMF

                    219MF10378
                    Ceftriaxone sodium at 163-3, SAMSUN...
                    2007-12-19
                    Written Confirmation

                    Close WC

                    Application Number
                    219MF10378
                    Status
                     
                    Filing Details
                    Ceftriaxone sodium at 163-3, SAMSUN...
                    Issue/Submission Date
                    2007-12-19
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                      Cefuroxime Axetil

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                      USDMF

                      Close USDMF

                      CEP/COS

                      Found CEP/COS

                      R1-CEP 2003-114 - Rev 00
                      Valid
                      Cefuroxime axetil
                      2011-02-04
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      R1-CEP 2003-114 - Rev 00
                      Status
                      Valid
                       
                      Filing Details
                      Cefuroxime axetil
                      Issue/Submission Date
                      2011-02-04
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                        Cloxacillin Sodium

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Found JDMF

                        218MF11024
                        [Japanese Pharmacopoeia] cloxacilli...
                        2006-12-28
                        Written Confirmation

                        Close WC

                        Application Number
                        218MF11024
                        Status
                         
                        Filing Details
                        [Japanese Pharmacopoeia] cloxacilli...
                        Issue/Submission Date
                        2006-12-28
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