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

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    01 2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (10275-S) EPITIOSTANOL (1)

    02 CERULETIDE DIETHYLAMINE (1)

    03 COMPOUND # 450088-S (1)

    04 COMPOUND 7432-S (1)

    05 COMPOUND NUMBER 6059-S (1)

    06 KEFLEX R SUSTAINED RELEASE CAPSULES (CEPHALEXIN MONOHYDRATE LILLY) (1)

    07 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KANEGASAKI, JAPAN. (1)

    08 MOXALACTAM DIACID (1)

    09 OSPEMIFENE (1)

    10 SULFAMETHOXAZOLE N.F. (1)

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    01 SHIONOGI AND CO LTD (9)

    02 SHIONOGI INC (1)

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    01 U.S.A (10)

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    02 Inactive (9)

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    01 Blank (10)

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      CERULETIDE DIETHYLAMINE

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      SHIONOGI AND CO LTD
      Inactive
      4661
      N/A
      1982-09-30
      II
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        COMPOUND 7432-S

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        SHIONOGI AND CO LTD
        Inactive
        6883
        N/A
        1987-03-18
        II
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          KEFLEX R SUSTAINED RELEASE CAPSULES...

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          SHIONOGI AND CO LTD
          Inactive
          3118
          N/A
          1977-11-17
          II
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            OSPEMIFENE

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            SHIONOGI INC
            Active
            35877
            N/A
            2021-07-29
            II
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              SULFAMETHOXAZOLE N.F.

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              SHIONOGI AND CO LTD
              Inactive
              2899
              N/A
              1977-04-11
              II
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                2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (...

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                SHIONOGI AND CO LTD
                Inactive
                1994
                N/A
                1972-09-18
                II
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                  COMPOUND # 450088-S

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                  SHIONOGI AND CO LTD
                  Inactive
                  3934
                  N/A
                  1980-09-09
                  II
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                    COMPOUND NUMBER 6059-S

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                    SHIONOGI AND CO LTD
                    Inactive
                    3395
                    N/A
                    1978-11-01
                    II
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                      MANUFACTURING SITE, FACILITIES, PER...

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                      SHIONOGI AND CO LTD
                      Inactive
                      9297
                      N/A
                      1991-08-20
                      II
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                        MOXALACTAM DIACID

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                        SHIONOGI AND CO LTD
                        Inactive
                        6675
                        N/A
                        1986-11-20
                        II
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