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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Ono Pharmaceutical to the U.S. FDA. Original Data : FDA Website

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    01 ALPROSTADIL ALFADEX (1)

    02 ALPROSTADIL ALFADEX I.V. (1)

    03 FACILITY AND OPERATING PROCEDURES IN OSAKA, JAPAN (1)

    04 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FUKUI, JAPAN. (1)

    05 ONO-2506 DRUG SUBSTANCE (1)

    06 PROSTAGLANDIN E1 (2)

    07 SIVELESTAT SODIUM HYDRATE (1)

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    01 MARUISHI PHARMACEUTICAL CO LTD (1)

    02 ONO PHARMACEUTICAL CO LTD (7)

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      ALPROSTADIL ALFADEX

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      MARUISHI PHARMACEUTIC...
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      2013-04-26
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        ALPROSTADIL ALFADEX I.V.

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        ONO PHARMACEUTICAL CO...
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        10415
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        1993-08-10
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          PROSTAGLANDIN E1

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          ONO PHARMACEUTICAL CO...
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          11534
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          1995-05-31
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            PROSTAGLANDIN E1

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            ONO PHARMACEUTICAL CO...
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            2008-07-30
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              SIVELESTAT SODIUM HYDRATE

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              ONO PHARMACEUTICAL CO...
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              2001-02-13
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                FACILITY AND OPERATING PROCEDURES I...

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                ONO PHARMACEUTICAL CO...
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                10305
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                1993-06-29
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                  MANUFACTURING SITE, FACILITIES, PER...

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                  ONO PHARMACEUTICAL CO...
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                  11272
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                  1994-12-30
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                    ONO-2506 DRUG SUBSTANCE

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                    ONO PHARMACEUTICAL CO...
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                    14271
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                    1999-06-30
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