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

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    Leo Pharma
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    Denmark
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    Industriparken 55
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    +45 4494 5888
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      Sodium Fusidate

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      USDMF

      Caution USDMF

      8527
      Inactive
      SODIUM FUSIDATE
      1990-04-16
      CEP/COS

      Found CEP/COS

      R0-CEP 2021-042 - Rev 00
      Valid
      Sodium fusidate, Process II
      2021-06-04
      Japanese DMF

      Found JDMF

      218MF10952
      Fusidic acid sodium at Industrypark...
      2006-11-24
      Written Confirmation

      Close WC

      Application Number
      8527
      R0-CEP 2021-042 - Rev 00
      218MF10952
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      SODIUM FUSIDATE
      Sodium fusidate, Process II
      Fusidic acid sodium at Industrypark...
      Issue/Submission Date
      1990-04-16
      2021-06-04
      2006-11-24
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        Calcipotriol

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        USDMF

        Caution USDMF

        8308
        Inactive
        CALCIPOTRIENE DRUG SUBSTANCE
        1989-11-01
        CEP/COS

        Found CEP/COS

        R1-CEP 2005-148 - Rev 01
        Valid
        Calcipotriol
        2013-03-13
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        8308
        R1-CEP 2005-148 - Rev 01
        Status
        Inactive
        Fees Unpaid
        N/A
        Valid
         
        Filing Details
        CALCIPOTRIENE DRUG SUBSTANCE
        Calcipotriol
        Issue/Submission Date
        1989-11-01
        2013-03-13
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          Calcipotriol

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          USDMF

          Caution USDMF

          8312
          Inactive
          CALCIPOTRIENE OINTMENT
          1989-11-27
          CEP/COS

          Found CEP/COS

          R1-CEP 2005-145 - Rev 01
          Valid
          Calcipotriol monohydrate
          2013-04-09
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          8312
          R1-CEP 2005-145 - Rev 01
          Status
          Inactive
          Fees Unpaid
          N/A
          Valid
           
          Filing Details
          CALCIPOTRIENE OINTMENT
          Calcipotriol monohydrate
          Issue/Submission Date
          1989-11-27
          2013-04-09
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            Fusidic Acid

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            USDMF

            Caution USDMF

            8526
            Inactive
            FUSIDIC ACID
            1990-04-16
            CEP/COS

            Found CEP/COS

            R1-CEP 2009-379 - Rev 00
            Valid
            Fusidic acid, Micronised, sterile
            2016-10-21
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            8526
            R1-CEP 2009-379 - Rev 00
            Status
            Inactive
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            FUSIDIC ACID
            Fusidic acid, Micronised, sterile
            Issue/Submission Date
            1990-04-16
            2016-10-21
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              Fusidic Acid

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              USDMF

              Caution USDMF

              8528
              Inactive
              FUCIDIN CREAM
              1990-04-16
              CEP/COS

              Found CEP/COS

              R0-CEP 2021-040 - Rev 01
              Valid
              Fusidic acid, Micronised, Process I...
              2022-01-19
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              8528
              R0-CEP 2021-040 - Rev 01
              Status
              Inactive
              Fees Unpaid
              N/A
              Valid
               
              Filing Details
              FUCIDIN CREAM
              Fusidic acid, Micronised, Process I...
              Issue/Submission Date
              1990-04-16
              2022-01-19
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                Fusidic Acid

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                USDMF

                Caution USDMF

                8529
                Inactive
                FUCIDIN OINTMENT
                1990-04-16
                CEP/COS

                Found CEP/COS

                R1-CEP 2009-308 - Rev 02
                Valid
                Fusidic acid, Micronised
                2022-01-19
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                8529
                R1-CEP 2009-308 - Rev 02
                Status
                Inactive
                Fees Unpaid
                N/A
                Valid
                 
                Filing Details
                FUCIDIN OINTMENT
                Fusidic acid, Micronised
                Issue/Submission Date
                1990-04-16
                2022-01-19
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                  Heparin Sodium

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                  USDMF

                  Caution USDMF

                  10477
                  Inactive
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  1993-09-03
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2001-446 - Rev 03
                  Valid
                  Heparin sodium, For parenteral prep...
                  2020-02-21
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  10477
                  R1-CEP 2001-446 - Rev 03
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                  Valid
                   
                  Filing Details
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  Heparin sodium, For parenteral prep...
                  Issue/Submission Date
                  1993-09-03
                  2020-02-21
                  ASK
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                    Alfacalcidol

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                    USDMF

                    Close USDMF

                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2007-286 - Rev 02
                    Valid
                    Alfacalcidol
                    2020-02-18
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    R1-CEP 2007-286 - Rev 02
                    Status
                    Valid
                     
                    Filing Details
                    Alfacalcidol
                    Issue/Submission Date
                    2020-02-18
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                      Calcipotriol

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                      USDMF

                      Found USDMF

                      10514
                      Active
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      1993-10-08
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      10514
                      Status
                      Active
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      Issue/Submission Date
                      1993-10-08
                      ASK
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                        Calcipotriol

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                        See Less

                        USDMF

                        Found USDMF

                        10515
                        Active
                        CALCIPOTRIENE CREAM
                        1993-10-08
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        10515
                        Status
                        Active
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        CALCIPOTRIENE CREAM
                        Issue/Submission Date
                        1993-10-08
                        ASK
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                          Heparin Sodium

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                          USDMF

                          Caution USDMF

                          10589
                          Inactive
                          HEPARIN SODIUM DRUG SUBSTANCE
                          1993-11-22
                          CEP/COS

                          Caution CEP/COS

                          R1-CEP 2001-445 - Rev 02
                          Withdrawn by Holder
                          Heparin sodium, Potency not less th...
                          2011-03-30
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          10589
                          R1-CEP 2001-445 - Rev 02
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                          Withdrawn by Holder
                           
                          Filing Details
                          HEPARIN SODIUM DRUG SUBSTANCE
                          Heparin sodium, Potency not less th...
                          Issue/Submission Date
                          1993-11-22
                          2011-03-30
                          ASK
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                            Sodium Fusidate

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                            USDMF

                            Close USDMF

                            CEP/COS

                            Found CEP/COS

                            R0-CEP 2021-041 - Rev 01
                            Valid
                            Sodium fusidate, Micronised, Proces...
                            2022-01-19
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            R0-CEP 2021-041 - Rev 01
                            Status
                            Valid
                             
                            Filing Details
                            Sodium fusidate, Micronised, Proces...
                            Issue/Submission Date
                            2022-01-19
                            ASK
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                              Sodium Fusidate

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                              USDMF

                              Close USDMF

                              CEP/COS

                              Found CEP/COS

                              R1-CEP 2009-317 - Rev 02
                              Valid
                              Sodium fusidate, Micronised
                              2022-01-19
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              R1-CEP 2009-317 - Rev 02
                              Status
                              Valid
                               
                              Filing Details
                              Sodium fusidate, Micronised
                              Issue/Submission Date
                              2022-01-19
                              ASK
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                              PHARMACOMPASS
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                                Sodium Fusidate

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                                USDMF

                                Close USDMF

                                CEP/COS

                                Found CEP/COS

                                R1-CEP 2009-309 - Rev 00
                                Valid
                                Sodium fusidate
                                2016-07-29
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                R1-CEP 2009-309 - Rev 00
                                Status
                                Valid
                                 
                                Filing Details
                                Sodium fusidate
                                Issue/Submission Date
                                2016-07-29
                                ASK
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                                  Amdinocillin

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                                  USDMF

                                  Caution USDMF

                                  13639
                                  Inactive
                                  AMDINOCILLIN
                                  1998-09-01
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  13639
                                  Status
                                  Inactive
                                  Fees Unpaid
                                  N/A
                                   
                                  Filing Details
                                  AMDINOCILLIN
                                  Issue/Submission Date
                                  1998-09-01
                                  ASK
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                                    Amdinocillin

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                                    USDMF

                                    Caution USDMF

                                    13662
                                    Inactive
                                    AMDINOCILLIN
                                    1998-09-01
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    13662
                                    Status
                                    Inactive
                                    Fees Unpaid
                                    N/A
                                     
                                    Filing Details
                                    AMDINOCILLIN
                                    Issue/Submission Date
                                    1998-09-01
                                    ASK
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                                      Bumetanide

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                                      USDMF

                                      Caution USDMF

                                      12702
                                      Inactive
                                      BUMETANIDE PURE MICRONISED
                                      1997-10-15
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      12702
                                      Status
                                      Inactive
                                      Fees Unpaid
                                      N/A
                                       
                                      Filing Details
                                      BUMETANIDE PURE MICRONISED
                                      Issue/Submission Date
                                      1997-10-15
                                      ASK
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                                        Calcipotriol

                                        PDF Supplier PDF
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                                        See Less

                                        USDMF

                                        Caution USDMF

                                        8714
                                        Inactive
                                        CALCIPOTRIOL SOLUTION CREAM DRUG PR...
                                        1990-08-24
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        8714
                                        Status
                                        Inactive
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        CALCIPOTRIOL SOLUTION CREAM DRUG PR...
                                        Issue/Submission Date
                                        1990-08-24
                                        ASK
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                                          Calcipotriol

                                          PDF Supplier PDF
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                                          See Less

                                          USDMF

                                          Caution USDMF

                                          8715
                                          Inactive
                                          CALCIPOTRIOL SUSPENSION CREAM DRUG ...
                                          1990-08-24
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          8715
                                          Status
                                          Inactive
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          CALCIPOTRIOL SUSPENSION CREAM DRUG ...
                                          Issue/Submission Date
                                          1990-08-24
                                          ASK
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                                            Calcipotriol

                                            PDF Supplier PDF
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                                            See Less

                                            USDMF

                                            Caution USDMF

                                            10839
                                            Inactive
                                            CALCIPOTRIENE SCALP SOLUTION
                                            1994-03-30
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            10839
                                            Status
                                            Inactive
                                            Fees Unpaid
                                            N/A
                                             
                                            Filing Details
                                            CALCIPOTRIENE SCALP SOLUTION
                                            Issue/Submission Date
                                            1994-03-30
                                            ASK
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                                              Calcipotriol

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                                              See Less

                                              USDMF

                                              Caution USDMF

                                              10843
                                              Inactive
                                              FACILITY FOR THE MANUFACTURE OF CAL...
                                              1994-03-30
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              10843
                                              Status
                                              Inactive
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              FACILITY FOR THE MANUFACTURE OF CAL...
                                              Issue/Submission Date
                                              1994-03-30
                                              ASK
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                                                Dalteparin sodium

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                                                USDMF

                                                Caution USDMF

                                                10596
                                                Inactive
                                                TINZAPARIN SODIUM DRUG SUBSTANCE
                                                1993-12-07
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                10596
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                 
                                                Filing Details
                                                TINZAPARIN SODIUM DRUG SUBSTANCE
                                                Issue/Submission Date
                                                1993-12-07
                                                ASK
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                                                  Fusidic Acid

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                                                  USDMF

                                                  Caution USDMF

                                                  8896
                                                  Inactive
                                                  FUCIDIN GEL DRUG PRODUCT
                                                  1990-12-18
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  8896
                                                  Status
                                                  Inactive
                                                  Fees Unpaid
                                                  N/A
                                                   
                                                  Filing Details
                                                  FUCIDIN GEL DRUG PRODUCT
                                                  Issue/Submission Date
                                                  1990-12-18
                                                  ASK
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                                                    Heparin Sodium

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                                                    USDMF

                                                    Caution USDMF

                                                    14038
                                                    Inactive
                                                    HEPARIN SODIUM DRUG SUBSTANCE
                                                    1999-03-19
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    14038
                                                    Status
                                                    Inactive
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Filing Details
                                                    HEPARIN SODIUM DRUG SUBSTANCE
                                                    Issue/Submission Date
                                                    1999-03-19
                                                    ASK
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                                                      Heparin Sodium

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                                                      USDMF

                                                      Caution USDMF

                                                      14039
                                                      Inactive
                                                      HEPARINASE DRUG SUBSTANCE
                                                      1999-03-19
                                                      CEP/COS

                                                      Close CEP/COS

                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Close WC

                                                      Application Number
                                                      14039
                                                      Status
                                                      Inactive
                                                      Fees Unpaid
                                                      N/A
                                                       
                                                      Filing Details
                                                      HEPARINASE DRUG SUBSTANCE
                                                      Issue/Submission Date
                                                      1999-03-19
                                                      ASK
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                                                        Pivmecilinamo Clorhidrato

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                                                        USDMF

                                                        Caution USDMF

                                                        14246
                                                        Inactive
                                                        AMDINOCILLIN PIVOXIL HCL
                                                        1999-07-06
                                                        CEP/COS

                                                        Close CEP/COS

                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Close WC

                                                        Application Number
                                                        14246
                                                        Status
                                                        Inactive
                                                        Fees Unpaid
                                                        N/A
                                                         
                                                        Filing Details
                                                        AMDINOCILLIN PIVOXIL HCL
                                                        Issue/Submission Date
                                                        1999-07-06
                                                        ASK
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                                                          Seocalcitol

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                                                          USDMF

                                                          Caution USDMF

                                                          10840
                                                          Inactive
                                                          EB 1089
                                                          1994-03-30
                                                          CEP/COS

                                                          Close CEP/COS

                                                          Japanese DMF

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                                                          Written Confirmation

                                                          Close WC

                                                          Application Number
                                                          10840
                                                          Status
                                                          Inactive
                                                          Fees Unpaid
                                                          N/A
                                                           
                                                          Filing Details
                                                          EB 1089
                                                          Issue/Submission Date
                                                          1994-03-30
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                                                            Sodium Fusidate

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                                                            USDMF

                                                            Close USDMF

                                                            CEP/COS

                                                            Caution CEP/COS

                                                            R0-CEP 2009-380 - Rev 00
                                                            Withdrawn by Holder
                                                            Sodium fusidate, Sterile
                                                            2011-11-14
                                                            Japanese DMF

                                                            Close JDMF

                                                            Written Confirmation

                                                            Close WC

                                                            Application Number
                                                            R0-CEP 2009-380 - Rev 00
                                                            Status
                                                            Withdrawn by Holder
                                                             
                                                            Filing Details
                                                            Sodium fusidate, Sterile
                                                            Issue/Submission Date
                                                            2011-11-14
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                                                              Sodium Taurodihydrofusidate

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                                                              USDMF

                                                              Caution USDMF

                                                              6884
                                                              Inactive
                                                              SODIUM TAURO-24,25-DIHYDROFUSIDATE ...
                                                              1987-03-23
                                                              CEP/COS

                                                              Close CEP/COS

                                                              Japanese DMF

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                                                              Written Confirmation

                                                              Close WC

                                                              Application Number
                                                              6884
                                                              Status
                                                              Inactive
                                                              Fees Unpaid
                                                              N/A
                                                               
                                                              Filing Details
                                                              SODIUM TAURO-24,25-DIHYDROFUSIDATE ...
                                                              Issue/Submission Date
                                                              1987-03-23
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                                                                MECILLINAM FOR INJECTION

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                                                                USDMF

                                                                Caution USDMF

                                                                3237
                                                                Inactive
                                                                MECILLINAM FOR INJECTION
                                                                1978-06-05
                                                                CEP/COS

                                                                Close CEP/COS

                                                                Japanese DMF

                                                                Close JDMF

                                                                Written Confirmation

                                                                Close WC

                                                                Application Number
                                                                3237
                                                                Status
                                                                Inactive
                                                                Fees Unpaid
                                                                N/A
                                                                 
                                                                Filing Details
                                                                MECILLINAM FOR INJECTION
                                                                Issue/Submission Date
                                                                1978-06-05
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                                                                  FACILS & CONTROLS USED IN MFGR OF SODIUM FUSIDATE CAPS.

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                                                                  USDMF

                                                                  Caution USDMF

                                                                  4548
                                                                  Inactive
                                                                  FACILS & CONTROLS USED IN MFGR OF S...
                                                                  1982-03-18
                                                                  CEP/COS

                                                                  Close CEP/COS

                                                                  Japanese DMF

                                                                  Close JDMF

                                                                  Written Confirmation

                                                                  Close WC

                                                                  Application Number
                                                                  4548
                                                                  Status
                                                                  Inactive
                                                                  Fees Unpaid
                                                                  N/A
                                                                   
                                                                  Filing Details
                                                                  FACILS & CONTROLS USED IN MFGR OF S...
                                                                  Issue/Submission Date
                                                                  1982-03-18
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                                                                    PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

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                                                                    USDMF

                                                                    Caution USDMF

                                                                    4593
                                                                    Inactive
                                                                    PERSONNEL, FACILITIES AND GENERAL O...
                                                                    1982-07-07
                                                                    CEP/COS

                                                                    Close CEP/COS

                                                                    Japanese DMF

                                                                    Close JDMF

                                                                    Written Confirmation

                                                                    Close WC

                                                                    Application Number
                                                                    4593
                                                                    Status
                                                                    Inactive
                                                                    Fees Unpaid
                                                                    N/A
                                                                     
                                                                    Filing Details
                                                                    PERSONNEL, FACILITIES AND GENERAL O...
                                                                    Issue/Submission Date
                                                                    1982-07-07
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                                                                      FACILITIES AND OPERATING PROCEDURES IN BALLERUP, DENMAR...

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                                                                      USDMF

                                                                      Caution USDMF

                                                                      8313
                                                                      Inactive
                                                                      FACILITIES AND OPERATING PROCEDURES...
                                                                      1989-11-27
                                                                      CEP/COS

                                                                      Close CEP/COS

                                                                      Japanese DMF

                                                                      Close JDMF

                                                                      Written Confirmation

                                                                      Close WC

                                                                      Application Number
                                                                      8313
                                                                      Status
                                                                      Inactive
                                                                      Fees Unpaid
                                                                      N/A
                                                                       
                                                                      Filing Details
                                                                      FACILITIES AND OPERATING PROCEDURES...
                                                                      Issue/Submission Date
                                                                      1989-11-27
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                                                                        FACILITIES AND OPERATING PROCEDURES

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                                                                        USDMF

                                                                        Caution USDMF

                                                                        8322
                                                                        Inactive
                                                                        FACILITIES AND OPERATING PROCEDURES
                                                                        1989-11-27
                                                                        CEP/COS

                                                                        Close CEP/COS

                                                                        Japanese DMF

                                                                        Close JDMF

                                                                        Written Confirmation

                                                                        Close WC

                                                                        Application Number
                                                                        8322
                                                                        Status
                                                                        Inactive
                                                                        Fees Unpaid
                                                                        N/A
                                                                         
                                                                        Filing Details
                                                                        FACILITIES AND OPERATING PROCEDURES
                                                                        Issue/Submission Date
                                                                        1989-11-27
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                                                                          INNOHEP INJECTION 20,000 ANTI-XA IR/ML

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                                                                          USDMF

                                                                          Caution USDMF

                                                                          10597
                                                                          Inactive
                                                                          INNOHEP INJECTION 20,000 ANTI-XA IR...
                                                                          1993-12-07
                                                                          CEP/COS

                                                                          Close CEP/COS

                                                                          Japanese DMF

                                                                          Close JDMF

                                                                          Written Confirmation

                                                                          Close WC

                                                                          Application Number
                                                                          10597
                                                                          Status
                                                                          Inactive
                                                                          Fees Unpaid
                                                                          N/A
                                                                           
                                                                          Filing Details
                                                                          INNOHEP INJECTION 20,000 ANTI-XA IR...
                                                                          Issue/Submission Date
                                                                          1993-12-07
                                                                          ASK
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                                                                            FACILITY FOR THE MANUFACTURE OF EB 1089 IN BALLERUP, DE...

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                                                                            USDMF

                                                                            Caution USDMF

                                                                            10842
                                                                            Inactive
                                                                            FACILITY FOR THE MANUFACTURE OF EB ...
                                                                            1994-03-30
                                                                            CEP/COS

                                                                            Close CEP/COS

                                                                            Japanese DMF

                                                                            Close JDMF

                                                                            Written Confirmation

                                                                            Close WC

                                                                            Application Number
                                                                            10842
                                                                            Status
                                                                            Inactive
                                                                            Fees Unpaid
                                                                            N/A
                                                                             
                                                                            Filing Details
                                                                            FACILITY FOR THE MANUFACTURE OF EB ...
                                                                            Issue/Submission Date
                                                                            1994-03-30
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                                                                              EB 1089 EC-CAPSULES DRUG PRODUCT

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                                                                              USDMF

                                                                              Caution USDMF

                                                                              11505
                                                                              Inactive
                                                                              EB 1089 EC-CAPSULES DRUG PRODUCT
                                                                              1995-05-12
                                                                              CEP/COS

                                                                              Close CEP/COS

                                                                              Japanese DMF

                                                                              Close JDMF

                                                                              Written Confirmation

                                                                              Close WC

                                                                              Application Number
                                                                              11505
                                                                              Status
                                                                              Inactive
                                                                              Fees Unpaid
                                                                              N/A
                                                                               
                                                                              Filing Details
                                                                              EB 1089 EC-CAPSULES DRUG PRODUCT
                                                                              Issue/Submission Date
                                                                              1995-05-12
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