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

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    01 Alprostadil (2)

    02 Alprostadil Alfadex (2)

    03 Sivelestat Sodium Hydrate (1)

    04 Blank (3)

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    01 Active (1)

    02 Inactive (7)

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      Alprostadil Alfadex

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      USDMF

      Found USDMF

      27130
      Active
      ALPROSTADIL ALFADEX
      2013-04-26
      CEP/COS

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      Japanese DMF

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      Written Confirmation

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      Application Number
      27130
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      ALPROSTADIL ALFADEX
      Issue/Submission Date
      2013-04-26
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        Alprostadil

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        USDMF

        Caution USDMF

        11534
        Inactive
        PROSTAGLANDIN E1
        1995-05-31
        CEP/COS

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        Japanese DMF

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        Written Confirmation

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        Application Number
        11534
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        PROSTAGLANDIN E1
        Issue/Submission Date
        1995-05-31
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          Alprostadil

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          USDMF

          Caution USDMF

          21906
          Inactive
          PROSTAGLANDIN E1
          2008-07-30
          CEP/COS

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          Japanese DMF

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          Written Confirmation

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          Application Number
          21906
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          PROSTAGLANDIN E1
          Issue/Submission Date
          2008-07-30
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            Alprostadil Alfadex

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            USDMF

            Caution USDMF

            10415
            Inactive
            ALPROSTADIL ALFADEX I.V.
            1993-08-10
            CEP/COS

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            Japanese DMF

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            Application Number
            10415
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            ALPROSTADIL ALFADEX I.V.
            Issue/Submission Date
            1993-08-10
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              Sivelestat Sodium Hydrate

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              USDMF

              Caution USDMF

              15270
              Inactive
              SIVELESTAT SODIUM HYDRATE
              2001-02-13
              CEP/COS

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              Japanese DMF

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              Written Confirmation

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              Application Number
              15270
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              SIVELESTAT SODIUM HYDRATE
              Issue/Submission Date
              2001-02-13
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                FACILITY AND OPERATING PROCEDURES IN OSAKA, JAPAN

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                USDMF

                Caution USDMF

                10305
                Inactive
                FACILITY AND OPERATING PROCEDURES I...
                1993-06-29
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                10305
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                FACILITY AND OPERATING PROCEDURES I...
                Issue/Submission Date
                1993-06-29
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                  MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                  USDMF

                  Caution USDMF

                  11272
                  Inactive
                  MANUFACTURING SITE, FACILITIES, PER...
                  1994-12-30
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

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                  Written Confirmation

                  Close WC

                  Application Number
                  11272
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  MANUFACTURING SITE, FACILITIES, PER...
                  Issue/Submission Date
                  1994-12-30
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                    ONO-2506 DRUG SUBSTANCE

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                    USDMF

                    Caution USDMF

                    14271
                    Inactive
                    ONO-2506 DRUG SUBSTANCE
                    1999-06-30
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    14271
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    ONO-2506 DRUG SUBSTANCE
                    Issue/Submission Date
                    1999-06-30
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