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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi Anti-Infectives

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    Fresenius Kabi Anti-Infectives
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    Italy
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    Address
    Via Roma, 108 - 20051 Cassina De Pecchi – Milano
    Telephone
    Telephone
    +39 02 92 46 291
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    enquiries@pharmacompass.com
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    https://www.fk-antiinfectives.com/
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      Cefepime Hydrochloride

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      USDMF

      Found USDMF

      27971
      Active
      CEFEPIME HYDROCHLORIDE STERILE
      2014-01-20
      CEP/COS

      Found CEP/COS

      CEP 2022-460 - Rev 00
      Valid
      Cefepime dihydrochloride monohydrat...
      2023-09-13
      Japanese DMF

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      Application Number
      27971
      CEP 2022-460 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      CEFEPIME HYDROCHLORIDE STERILE
      Cefepime dihydrochloride monohydrat...
      Issue/Submission Date
      2014-01-20
      2023-09-13
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        Ampicillin Sodium

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        USDMF

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        CEP/COS

        Found CEP/COS

        CEP 2012-224 - Rev 05
        Valid
        Ampicillin sodium
        2024-02-20
        Japanese DMF

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        Written Confirmation

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        Application Number
        CEP 2012-224 - Rev 05
        Status
        Valid
         
        Filing Details
        Ampicillin sodium
        Issue/Submission Date
        2024-02-20
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          Cefepime

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          USDMF

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          CEP/COS

          Found CEP/COS

          R1-CEP 2007-205 - Rev 06
          Valid
          Cefepime dihydrochloride monohydrat...
          2022-11-07
          Japanese DMF

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          Application Number
          R1-CEP 2007-205 - Rev 06
          Status
          Valid
           
          Filing Details
          Cefepime dihydrochloride monohydrat...
          Issue/Submission Date
          2022-11-07
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            Cefotaxime

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            USDMF

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            CEP/COS

            Found CEP/COS

            R1-CEP 1999-056 - Rev 07
            Valid
            Cefotaxime sodium, Sterile
            2021-02-10
            Japanese DMF

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            Application Number
            R1-CEP 1999-056 - Rev 07
            Status
            Valid
             
            Filing Details
            Cefotaxime sodium, Sterile
            Issue/Submission Date
            2021-02-10
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              Ceftazidime

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              USDMF

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              CEP/COS

              Found CEP/COS

              R0-CEP 2018-008 - Rev 01
              Valid
              Ceftazidime pentahydrate with sodiu...
              2021-02-11
              Japanese DMF

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              Application Number
              R0-CEP 2018-008 - Rev 01
              Status
              Valid
               
              Filing Details
              Ceftazidime pentahydrate with sodiu...
              Issue/Submission Date
              2021-02-11
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                Ceftazidime

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                USDMF

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                CEP/COS

                Found CEP/COS

                R1-CEP 2004-129 - Rev 07
                Valid
                Ceftazidime Pentahydrate, Sterile
                2023-05-26
                Japanese DMF

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                Application Number
                R1-CEP 2004-129 - Rev 07
                Status
                Valid
                 
                Filing Details
                Ceftazidime Pentahydrate, Sterile
                Issue/Submission Date
                2023-05-26
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                  Ceftriaxone

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                  USDMF

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                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2004-119 - Rev 08
                  Valid
                  Ceftriaxone sodium, Sterile
                  2021-02-10
                  Japanese DMF

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                  Application Number
                  R1-CEP 2004-119 - Rev 08
                  Status
                  Valid
                   
                  Filing Details
                  Ceftriaxone sodium, Sterile
                  Issue/Submission Date
                  2021-02-10
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                    Ceftriaxone

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                    USDMF

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                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2010-232 - Rev 04
                    Valid
                    Ceftriaxone sodium
                    2021-08-27
                    Japanese DMF

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                    Written Confirmation

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                    Application Number
                    R1-CEP 2010-232 - Rev 04
                    Status
                    Valid
                     
                    Filing Details
                    Ceftriaxone sodium
                    Issue/Submission Date
                    2021-08-27
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                      Cefuroxime Sodium

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                      USDMF

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                      CEP/COS

                      Found CEP/COS

                      R1-CEP 1997-044 - Rev 11
                      Valid
                      Cefuroxime sodium, Sterile
                      2021-12-17
                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      R1-CEP 1997-044 - Rev 11
                      Status
                      Valid
                       
                      Filing Details
                      Cefuroxime sodium, Sterile
                      Issue/Submission Date
                      2021-12-17
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                        Cloxacillin Sodium

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                        USDMF

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                        CEP/COS

                        Found CEP/COS

                        R1-CEP 1996-091 - Rev 08
                        Valid
                        Cloxacillin sodium, Powder and comp...
                        2021-02-10
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

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                        Application Number
                        R1-CEP 1996-091 - Rev 08
                        Status
                        Valid
                         
                        Filing Details
                        Cloxacillin sodium, Powder and comp...
                        Issue/Submission Date
                        2021-02-10
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                          Degarelix Acetate

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                          USDMF

                          Found USDMF

                          36499
                          Active
                          DEGARELIX ACETATE
                          2023-01-19
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

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                          Written Confirmation

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                          Application Number
                          36499
                          Status
                          Active
                          Fees Paid
                          Reviewed
                           
                          Filing Details
                          DEGARELIX ACETATE
                          Issue/Submission Date
                          2023-01-19
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                            Flucloxacillin Sodium

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                            USDMF

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                            CEP/COS

                            Found CEP/COS

                            R1-CEP 1996-093 - Rev 06
                            Valid
                            Flucloxacillin sodium monohydrate, ...
                            2022-05-20
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

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                            Application Number
                            R1-CEP 1996-093 - Rev 06
                            Status
                            Valid
                             
                            Filing Details
                            Flucloxacillin sodium monohydrate, ...
                            Issue/Submission Date
                            2022-05-20
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                              Flucloxacillin Sodium

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                              USDMF

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                              CEP/COS

                              Found CEP/COS

                              R1-CEP 1996-054 - Rev 10
                              Valid
                              Flucloxacillin sodium monohydrate, ...
                              2022-05-17
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

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                              Application Number
                              R1-CEP 1996-054 - Rev 10
                              Status
                              Valid
                               
                              Filing Details
                              Flucloxacillin sodium monohydrate, ...
                              Issue/Submission Date
                              2022-05-17
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                                Piperacillin Sodium

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                                USDMF

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                                CEP/COS

                                Found CEP/COS

                                R1-CEP 2012-101 - Rev 03
                                Valid
                                Piperacillin monohydrate
                                2023-03-20
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                R1-CEP 2012-101 - Rev 03
                                Status
                                Valid
                                 
                                Filing Details
                                Piperacillin monohydrate
                                Issue/Submission Date
                                2023-03-20
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                                  Pivmecillinam

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                                  USDMF

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                                  CEP/COS

                                  Found CEP/COS

                                  R1-CEP 2004-262 - Rev 06
                                  Valid
                                  Pivmecillinam hydrochloride
                                  2023-02-01
                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

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                                  Application Number
                                  R1-CEP 2004-262 - Rev 06
                                  Status
                                  Valid
                                   
                                  Filing Details
                                  Pivmecillinam hydrochloride
                                  Issue/Submission Date
                                  2023-02-01
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                                    Sodium Dicloxacillin

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                                    USDMF

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                                    CEP/COS

                                    Found CEP/COS

                                    R1-CEP 2002-036 - Rev 07
                                    Valid
                                    Dicloxacillin sodium, Powder and co...
                                    2021-08-16
                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    R1-CEP 2002-036 - Rev 07
                                    Status
                                    Valid
                                     
                                    Filing Details
                                    Dicloxacillin sodium, Powder and co...
                                    Issue/Submission Date
                                    2021-08-16
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                                      Sulbactam Sodium

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                                      USDMF

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                                      CEP/COS

                                      Found CEP/COS

                                      R1-CEP 2007-228 - Rev 03
                                      Valid
                                      Sulbactam sodium, Sterile
                                      2021-02-02
                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

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                                      Application Number
                                      R1-CEP 2007-228 - Rev 03
                                      Status
                                      Valid
                                       
                                      Filing Details
                                      Sulbactam sodium, Sterile
                                      Issue/Submission Date
                                      2021-02-02
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                                        Cefazolin Sodium

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                                        USDMF

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                                        CEP/COS

                                        Caution CEP/COS

                                        R1-CEP 1998-092 - Rev 05
                                        Withdrawn by Holder
                                        Cefazolin sodium, sterile, process ...
                                        2010-11-08
                                        Japanese DMF

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                                        Written Confirmation

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                                        Application Number
                                        R1-CEP 1998-092 - Rev 05
                                        Status
                                        Withdrawn by Holder
                                         
                                        Filing Details
                                        Cefazolin sodium, sterile, process ...
                                        Issue/Submission Date
                                        2010-11-08
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                                          Cefoperazone Sodium

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                                          USDMF

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                                          CEP/COS

                                          Caution CEP/COS

                                          R1-CEP 2003-277 - Rev 04
                                          Withdrawn by Holder
                                          Cefoperazone sodium, Sterile
                                          2021-02-10
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          R1-CEP 2003-277 - Rev 04
                                          Status
                                          Withdrawn by Holder
                                           
                                          Filing Details
                                          Cefoperazone sodium, Sterile
                                          Issue/Submission Date
                                          2021-02-10
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                                            Cefoxitin Sodium

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                                            USDMF

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                                            CEP/COS

                                            Caution CEP/COS

                                            R0-CEP 2007-173 - Rev 01
                                            Expired
                                            Cefoxitin sodium, Sterile
                                            2013-04-24
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

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                                            Application Number
                                            R0-CEP 2007-173 - Rev 01
                                            Status
                                            Expired
                                             
                                            Filing Details
                                            Cefoxitin sodium, Sterile
                                            Issue/Submission Date
                                            2013-04-24
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                                              Piperacillin Sodium

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                                              USDMF

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                                              CEP/COS

                                              Caution CEP/COS

                                              R1-CEP 1998-123 - Rev 14
                                              Withdrawn by Holder
                                              Piperacillin sodium, Sterile
                                              2023-01-18
                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              R1-CEP 1998-123 - Rev 14
                                              Status
                                              Withdrawn by Holder
                                               
                                              Filing Details
                                              Piperacillin sodium, Sterile
                                              Issue/Submission Date
                                              2023-01-18
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