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

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    F.I.S. Fabbrica Italiana Sintetici
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    Italy
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    Viale Milano, 26, 36075 Montecchio, Maggiore, Vicenza (Italy)
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    +39-044-470-8011
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    ACETYLCYSTEINE, USP

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    FIS FABBRICA ITALIANA...
    Active
    5091
    N/A
    1983-07-04
    II
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    ALLOPURINOL

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    FABBRICA ITALIANA SIN...
    Inactive
    6373
    N/A
    1986-05-23
    II
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    BENZYL HYDRAZINE MSA (FIS0181)

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    FIS FABBRICA ITALIANA...
    Inactive
    20784
    N/A
    2007-08-07
    II
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    CARBAMAZEPINE

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    FIS FABBRICA ITALIANA...
    Active
    6641
    N/A
    1986-10-20
    II
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    CHLORDIAZEPOXIDE HCL

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    FIS FABBRICA ITALIANA...
    Active
    467
    Complete
    2017-11-16
    2017-10-26
    1962-02-15
    II
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    CLOBAZAM

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    FIS FABBRICA ITALIANA...
    Inactive
    18080
    N/A
    2005-02-10
    II
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    CLOBAZAM

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    FIS FABBRICA ITALIANA...
    Active
    24728
    Complete
    2015-10-02
    2015-03-11
    2011-02-28
    II
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    CLOMIPHENE CITRATE

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    FIS FABBRICA ITALIANA...
    Active
    5674
    Complete
    2014-10-21
    2013-07-05
    1984-12-20
    II
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    CLONAZEPAM

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    FIS FABBRICA ITALIANA...
    Active
    7505
    Complete
    2015-05-04
    2015-04-21
    1988-06-01
    II
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    CLORAZEPATE DIPOTASSIUM

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    FABBRICA ITALIANA SIN...
    Inactive
    5922
    N/A
    1985-07-24
    II
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    CLOTRIMAZOLE

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    FIS FABBRICA ITALIANA...
    Active
    7548
    Complete
    2015-01-07
    2014-12-18
    1988-06-21
    II
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    CMT

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    FIS FABBRICA ITALIANA...
    Inactive
    17059
    N/A
    2003-12-19
    II
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    DESIPRAMINE HYDROCHLORIDE

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    FABBRICA ITALIANA SIN...
    Inactive
    7401
    N/A
    1988-03-22
    II
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    DIAZEPAM

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    FIS FABBRICA ITALIANA...
    Active
    3164
    Complete
    2012-10-24
    2013-05-13
    1978-02-28
    II
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    DILTIAZEM HYDROCHLORIDE

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    FABBRICA ITALIANA SIN...
    Inactive
    7908
    N/A
    1989-01-26
    II
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    DILTIAZEM HYDROCHLORIDE

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    FIS FABBRICA ITALIANA...
    Active
    7600
    Complete
    2013-01-18
    2012-12-12
    1988-07-18
    II
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    DORZOLAMIDE HYDROCHLORIDE

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    FIS FABBRICA ITALIANA...
    Inactive
    20740
    N/A
    2007-07-27
    II
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    DORZOLAMIDE HYDROCHLORIDE (ALTERNAT...

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    FIS FABBRICA ITALIANA...
    Active
    29584
    Complete
    2018-06-13
    2017-11-21
    2015-07-24
    II
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      DUTASTERIDE

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      FIS FABBRICA ITALIANA...
      Inactive
      23494
      N/A
      2010-04-30
      II
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      ELETRIPTAN HYDROBROMIDE

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      FIS FABBRICA ITALIANA...
      Active
      24528
      Complete
      2013-12-18
      2013-10-25
      2010-12-29
      II
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      ENCLOMIPHENE CITRATE

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      FIS FABBRICA ITALIANA...
      Active
      31739
      Complete
      2017-12-15
      2017-05-11
      2017-05-25
      II
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      ENTACAPONE

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      FIS FABBRICA ITALIANA...
      Active
      23984
      N/A
      2010-07-13
      II
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      ERLOTINIB HYDROCHLORIDE

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      FIS FABBRICA ITALIANA...
      Active
      32197
      Complete
      2018-03-22
      2017-10-31
      2017-12-18
      II
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      ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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      FIS FABBRICA ITALIANA...
      Active
      24901
      Complete
      2014-05-05
      2013-04-05
      2011-04-20
      II
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      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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      FIS FABBRICA ITALIANA...
      Active
      33367
      N/A
      2018-12-20
      II
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      ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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      FIS FABBRICA ITALIANA...
      Inactive
      25080
      N/A
      2011-04-20
      II
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      ESTAZOLAM

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      FIS FABBRICA ITALIANA...
      Active
      11784
      N/A
      1995-12-20
      II
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      FIS1174

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      FIS FABBRICA ITALIANA...
      Inactive
      21769
      N/A
      2008-06-18
      II
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      FLURAZEPAM HCl

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      FIS FABBRICA ITALIANA...
      Active
      5282
      N/A
      1984-02-27
      II
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        FLUVASTATIN SODIUM HYDRATE USP

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        FIS FABBRICA ITALIANA...
        Active
        18911
        Complete
        2018-10-25
        2018-10-22
        2005-10-11
        II
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        FOSFOMYCIN TROMETAMOL

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        FIS FABBRICA ITALIANA...
        Active
        10891
        N/A
        1994-04-28
        II
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        FURAZOLIDONE BULK

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        FABBRICA ITALIANA SIN...
        Inactive
        4338
        N/A
        1981-10-16
        II
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        FUROSEMIDE

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        FIS FABBRICA ITALIANA...
        Active
        3513
        Complete
        2015-03-16
        2015-03-11
        1979-03-08
        II
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        GABAPENTIN

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        FIS FABBRICA ITALIANA...
        Active
        14024
        N/A
        1999-03-19
        II
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          IMATINIB MESYLATE

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          PHF SA
          Inactive
          24287
          N/A
          2010-12-09
          II
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          IMATINIB MESYLATE (ALPHA FORM)

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          FIS FABBRICA ITALIANA...
          Active
          25206
          Complete
          2017-03-24
          2015-12-21
          2011-07-27
          II
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          IMATINIB MESYLATE (BETA FORM)

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          FIS FABBRICA ITALIANA...
          Active
          25205
          N/A
          2011-07-26
          II
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          INDOMETHACIN

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          FIS FABBRICA ITALIANA...
          Active
          3136
          Complete
          2013-02-26
          2013-02-07
          1978-01-23
          II
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          INDOMETHACIN SODIUM

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          FIS FABBRICA ITALIANA...
          Active
          29441
          Complete
          2016-05-31
          2015-09-30
          2015-09-30
          II
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            LENALIDOMIDE

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            ZYDUS LIFESCIENCES LT...
            Active
            27116
            Complete
            2016-03-03
            2015-04-13
            2013-06-04
            II
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            LORAZEPAM

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            FIS FABBRICA ITALIANA...
            Active
            5027
            Complete
            2014-06-27
            2014-06-20
            1983-05-17
            II
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              LUBIPROSTONE

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              FIS FABBRICA ITALIANA...
              Inactive
              24286
              N/A
              2010-11-08
              II
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              MIDAZOLAM HCI

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              FIS FABBRICA ITALIANA...
              Active
              25204
              Complete
              2018-06-29
              2018-02-20
              2011-08-01
              II
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              NEBIVOLOL HYDROCHLORIDE

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              FIS FABBRICA ITALIANA...
              Active
              22735
              Complete
              2014-10-13
              2014-10-06
              2009-03-31
              II
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              NIFEDIPINE USP

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              FIS FABBRICA ITALIANA...
              Active
              6339
              Complete
              2013-03-15
              2013-02-27
              1986-03-14
              II
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              NILOTINIB DIHYDROCHLORIDE DIHYDRATE

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              FIS FABBRICA ITALIANA...
              Active
              31740
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              2017-10-20
              2017-05-11
              2017-06-30
              II
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              NITROFURANTOIN & NITROFURANTOIN MAC...

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              FIS FABBRICA ITALIANA...
              Active
              453
              Complete
              2013-01-18
              2012-12-21
              1965-07-13
              II
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              NITROFURANTOIN MONOHYDRATE

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              FIS FABBRICA ITALIANA...
              Active
              13266
              Complete
              2013-01-11
              2012-12-10
              1998-10-05
              II
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              NITROFURANTOIN MONOHYDRATE (CODE 10...

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              FIS FABBRICA ITALIANA...
              Active
              21887
              Complete
              2015-01-08
              2014-12-18
              2008-08-05
              II
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                OLOPATADINE HCI USP

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                PHF SA
                Inactive
                24408
                N/A
                2010-12-17
                II
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