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

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    • FDA
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    ACETOHEXAMIDE

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    COSMA SPA
    Inactive
    7034
    N/A
    1987-06-16
    II
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    AMANTADINE HYDROCHLORIDE

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    ANONIMA MATERIE SINTE...
    Active
    29486
    N/A
    2015-09-01
    II
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    AMISULPRIDE

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    COSMA SPA
    Active
    33911
    N/A
    2019-06-11
    II
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    ANAGRELIDE HYDROCHLORIDE

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    AMSA ANONIMA MATERIE ...
    Inactive
    16969
    N/A
    2003-11-12
    II
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    ATENOLOL

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    COSMA SPA
    Inactive
    7933
    N/A
    1989-02-20
    II
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    ATENOLOL

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    AMSA ANONIMA MEDICINA...
    Inactive
    7265
    N/A
    1987-12-23
    II
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    BICALUTAMIDE

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    COSMA SPA
    Inactive
    19410
    N/A
    2006-04-21
    II
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    CARTEOLOL HYDROCHLORIDE

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    AMSA SPA
    Inactive
    14946
    N/A
    2000-07-03
    II
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    CETIRIZINE DIHYDROCHLORIDE

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    COSMA SPA
    Active
    20309
    N/A
    2007-02-21
    II
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    DICLOFENAC HYDROXY ETHYL PYRROLIDIN...

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    AMSA SPA
    Active
    14831
    N/A
    2000-04-10
    II
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    DICLOFENAC HYDROXY ETHYL PYRROLIDIN...

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    COSMA SPA
    Active
    27322
    N/A
    2014-03-04
    II
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    DROXIDOPA

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    CLAROCHEM IRELAND LTD
    Active
    33459
    Complete
    2019-03-20
    2019-01-31
    2019-01-04
    II
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    ETODOLAC

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    AMSA SPA
    Active
    11359
    N/A
    1995-02-20
    II
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    FENOFIBRATE

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    ANONIMA MATERIE SINTE...
    Inactive
    16971
    N/A
    2003-11-17
    II
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    FLECAINIDE ACETATE

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    AMSA ANONIMA MATERIE ...
    Active
    14749
    N/A
    2000-02-29
    II
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    GLICLAZIDE

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    COSMA SPA
    Active
    25538
    N/A
    2011-12-06
    II
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    GLIPIZIDE

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    AMSA SPA
    Active
    13101
    Complete
    2014-03-21
    2013-09-23
    1998-07-30
    II
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    GLYCOPYRROLATE

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    AMSA SPA
    Active
    16972
    Complete
    2015-03-13
    2015-03-06
    2003-11-13
    II
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    HYDROXYZINE HYDROCHLORIDE

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    COSMA SPA
    Active
    4435
    Complete
    2014-05-15
    2014-01-28
    1982-01-29
    II
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    HYDROXYZINE PAMOATE

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    COSMA SPA
    Active
    4514
    Complete
    2013-09-28
    2013-09-24
    1982-04-16
    II
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    KETOPROFEN

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    COSMA SPA
    Active
    7599
    Complete
    2015-10-28
    2015-03-27
    1988-07-21
    II
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    LABETALOL HYDROCHLORIDE

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    COSMA SPA
    Active
    14702
    N/A
    2000-02-04
    II
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    LEVOMILNACIPRAN HYDROCHLORIDE

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    COSMA SPA
    Active
    31327
    Complete
    2017-05-18
    2017-02-02
    2017-03-16
    II
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    LURASIDONE HYDROCHLORIDE

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    AMSA SPA
    Active
    27898
    Complete
    2014-06-24
    2014-01-24
    2014-04-30
    II
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    • FDA
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    MELOXICAM

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    ANONIMA MATERIE SINTE...
    Active
    17238
    Complete
    2016-04-01
    2016-03-02
    2004-03-16
    II
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    • FDA
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    MEMANTINE HYDROCHLORIDE

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    AMSA ANONIMA MATERIE ...
    Active
    19549
    Complete
    2013-06-06
    2013-05-22
    2006-06-20
    II
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    • FDA
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    METOCLOPRAMIDE HYDROCHLORIDE

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    COSMA SPA
    Active
    4523
    Complete
    2018-03-02
    2018-01-12
    1982-05-03
    II
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    METOPROLOL TARTRATE

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    COSMA SPA
    Inactive
    14324
    N/A
    1999-07-29
    II
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    MILNACIPRAN HYDROCHLORIDE

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    COSMA SPA
    Active
    25717
    Complete
    2013-07-05
    2012-12-20
    2012-02-23
    II
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    • FDA
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    OXAPROZIN

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    COSMA SPA
    Active
    12999
    N/A
    1998-05-21
    II
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    PANTETHINE

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    COSMA SPA
    Inactive
    10069
    N/A
    1993-02-01
    II
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    • FDA
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    PHENYLBUTAZONE

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    AMSA ANONIMA MEDICINA...
    Inactive
    1548
    N/A
    1970-07-23
    II
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    PROPRANOLOL HCL

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    COSMA SPA
    Active
    4104
    Complete
    2015-01-29
    2015-01-22
    1981-02-27
    II
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    • FDA
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    PYRANTEL PAMOATE

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    COSMA SPA
    Active
    7669
    N/A
    1988-09-09
    II
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    • FDA
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    RANOLAZINE

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    COSMA SPA
    Active
    22811
    Complete
    2014-02-10
    2013-02-05
    2009-06-15
    II
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    • FDA
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    SULFINPYRAZONE

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    COSMA SPA
    Inactive
    3915
    N/A
    1980-07-21
    II
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    TELMISARTAN

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    COSMA SPA
    Inactive
    24703
    N/A
    2011-05-12
    II
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    • FDA
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    TERBUTALINE SULPHATE

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    COSMA SPA
    Inactive
    4748
    N/A
    1982-11-29
    II
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    TOLAZAMIDE

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    COSMA SPA
    Inactive
    4735
    N/A
    1982-11-29
    II
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    TOLMETIN SODIUM

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    COSMA SPA
    Inactive
    7336
    N/A
    1988-02-05
    II
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    TOLMETIN SODIUM

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    AMSA SPA
    Inactive
    16432
    N/A
    2003-02-17
    II
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    • FDA
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    TORSEMIDE 1016

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    COSMA SPA
    Active
    15562
    N/A
    2001-07-31
    II
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    TORSEMIDE 1024

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    COSMA SPA
    Active
    15563
    N/A
    2001-07-31
    II
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    • FDA
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    ZOMPIRAC SODIUM

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    COSMA SPA
    Inactive
    4742
    N/A
    1982-11-29
    II
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    • FDA
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    CL1109

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    CLAROCHEM IRELAND LTD
    Active
    28209
    Complete
    2014-06-11
    2014-05-13
    2014-05-23
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    AMSA ANONIMA MEDICINA...
    Inactive
    7182
    N/A
    1987-10-09
    II
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    • FDA
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    PERSONNEL, FACILITIES AND GENERAL O...

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    COSMA SPA
    Inactive
    4086
    N/A
    1981-02-27
    II
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