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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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    01 ACETOHEXAMIDE (1)

    02 AMANTADINE HYDROCHLORIDE (1)

    03 AMISULPRIDE (1)

    04 ANAGRELIDE HYDROCHLORIDE (1)

    05 ATENOLOL (2)

    06 BICALUTAMIDE (1)

    07 CARTEOLOL HYDROCHLORIDE (1)

    08 CETIRIZINE DIHYDROCHLORIDE (1)

    09 CL1109 (1)

    10 DICLOFENAC HYDROXY ETHYL PYRROLIDINE (2)

    11 DROXIDOPA (1)

    12 ETODOLAC (1)

    13 FENOFIBRATE (1)

    14 FLECAINIDE ACETATE (1)

    15 GLICLAZIDE (1)

    16 GLIPIZIDE (1)

    17 GLYCOPYRROLATE (1)

    18 HYDROXYZINE HYDROCHLORIDE (1)

    19 HYDROXYZINE PAMOATE (1)

    20 KETOPROFEN (1)

    21 LABETALOL HYDROCHLORIDE (1)

    22 LEVOMILNACIPRAN HYDROCHLORIDE (1)

    23 LURASIDONE HYDROCHLORIDE (1)

    24 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILANO, ITALY. (1)

    25 MELOXICAM (1)

    26 MEMANTINE HYDROCHLORIDE (1)

    27 METOCLOPRAMIDE HYDROCHLORIDE (1)

    28 METOPROLOL TARTRATE (1)

    29 MILNACIPRAN HYDROCHLORIDE (1)

    30 OXAPROZIN (1)

    31 PANTETHINE (1)

    32 PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES (1)

    33 PHENYLBUTAZONE (1)

    34 PROPRANOLOL HCL (1)

    35 PYRANTEL PAMOATE (1)

    36 RANOLAZINE (1)

    37 SULFINPYRAZONE (1)

    38 TELMISARTAN (1)

    39 TERBUTALINE SULPHATE (1)

    40 TOLAZAMIDE (1)

    41 TOLMETIN SODIUM (2)

    42 TORSEMIDE 1016 (1)

    43 TORSEMIDE 1024 (1)

    44 ZOMPIRAC SODIUM (1)

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    01 AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA (3)

    02 AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPA (3)

    03 AMSA SPA (7)

    04 ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPA (3)

    05 CLAROCHEM IRELAND LTD (2)

    06 COSMA SPA (29)

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    01 Ireland (2)

    02 Italy (45)

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    01 Active (28)

    02 Inactive (19)

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    01 Complete (15)

    02 Blank (32)

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