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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Cosma S.p.a

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    COSMA S.p.A

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    01 Acetohexamide (1)

    02 Amantadine Hydrochloride (2)

    03 Amisulpride (1)

    04 Anagrelide Hydrochloride (1)

    05 Atenolol (2)

    06 Bicalutamide (1)

    07 Bromhexine Hydrochloride (1)

    08 Carprofen (1)

    09 Carteolol (1)

    10 Cetirizine (1)

    11 Cetirizine Dihydrochloride (1)

    12 Dexketoprofen Trometamol (1)

    13 Diclofenac (2)

    14 Droxidopa (1)

    15 Etodolac (1)

    16 Fenofibrate (1)

    17 Firocoxib (1)

    18 Flecainide (1)

    19 Fosfomycin (1)

    20 Gliclazide (1)

    21 Glipizide (1)

    22 Glycopyrronium Bromide (2)

    23 Glycopyrronium Tosylate (1)

    24 Hydroxyzine Dihydrochloride (1)

    25 Hydroxyzine Pamoate (1)

    26 Ketoprofen (1)

    27 Ketoprofen Lysinate (1)

    28 Labetalol Hydrochloride (1)

    29 Levocloperastine Fendizoate (1)

    30 Levodropropizine (2)

    31 Lurasidone Hydrochloride (1)

    32 Meloxicam (1)

    33 Memantine Hydrochloride (1)

    34 Metoclopramide (1)

    35 Metoclopramide Dihydrochloride (1)

    36 Metoclopramide Hydrochloride (2)

    37 Metoprolol Tartrate (1)

    38 Milnacipran HCl (2)

    39 Milnacipran Hydrochloride (1)

    40 Mirabegron (1)

    41 Oxantel Pamoate (1)

    42 Oxaprozin (1)

    43 Pantethine (1)

    44 Phenylbutazone (1)

    45 Propranolol Hydrochloride (1)

    46 Pyrantel Pamoate (2)

    47 Ranolazine (1)

    48 Rifaximin (1)

    49 Sulfinpyrazone (1)

    50 Telmisartan (1)

    51 Terbutaline Sulphate (1)

    52 Tolazamide (1)

    53 Tolmetin Sodium (2)

    54 Torsemide (2)

    55 Zomepirac (1)

    56 Blank (3)

    filter

    01 Active (28)

    02 Inactive (19)

    03 Blank (21)

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    01 Expired (1)

    02 Valid (8)

    03 Blank (59)

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    01 218MF11036 (1)

    02 218MF11037 (1)

    03 221MF10057 (1)

    04 221MF10278 (1)

    05 223MF10093 (1)

    06 302MF10148 (1)

    07 305MF10087 (1)

    08 Blank (61)

    filter

    01 Blank (68)

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    • FDA
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    Flecainide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14749
    Active
    FLECAINIDE ACETATE
    2000-02-29
    CEP/COS

    Found CEP/COS

    CEP 2009-363 - Rev 03
    Valid
    Flecainide acetate
    2023-12-06
    Japanese DMF

    Found JDMF

    223MF10093
    Flecainide acetate at VIALE DEL GHI...
    2011-06-29
    Written Confirmation

    Close WC

    Application Number
    14749
    CEP 2009-363 - Rev 03
    223MF10093
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLECAINIDE ACETATE
    Flecainide acetate
    Flecainide acetate at VIALE DEL GHI...
    Issue/Submission Date
    2000-02-29
    2023-12-06
    2011-06-29
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    Amisulpride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33911
    Active
    AMISULPRIDE
    2019-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-397 - Rev 01
    Valid
    Amisulpride
    2017-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33911
    R1-CEP 2009-397 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMISULPRIDE
    Amisulpride
    Issue/Submission Date
    2019-06-11
    2017-08-24
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    16972
    Active
    GLYCOPYRROLATE
    2003-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-194 - Rev 01
    Valid
    Glycopyrronium bromide
    2021-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16972
    R1-CEP 2014-194 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCOPYRROLATE
    Glycopyrronium bromide
    Issue/Submission Date
    2003-11-13
    2021-02-18
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    Hydroxyzine Pamoate

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    USDMF

    Found USDMF

    4514
    Active
    HYDROXYZINE PAMOATE
    1982-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF11037
    Hydroxy Jinpa model salt at Via Col...
    2006-12-28
    Written Confirmation

    Close WC

    Application Number
    4514
    218MF11037
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROXYZINE PAMOATE
    Hydroxy Jinpa model salt at Via Col...
    Issue/Submission Date
    1982-04-16
    2006-12-28
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    Ketoprofen

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7599
    Active
    KETOPROFEN
    1988-07-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-053 - Rev 03
    Valid
    Ketoprofen
    2020-04-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7599
    R1-CEP 2007-053 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    KETOPROFEN
    Ketoprofen
    Issue/Submission Date
    1988-07-21
    2020-04-21
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17238
    Active
    MELOXICAM
    2004-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF11036
    Meloxicam at VIALE DEL GHISALLO, 20...
    2006-12-28
    Written Confirmation

    Close WC

    Application Number
    17238
    218MF11036
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MELOXICAM
    Meloxicam at VIALE DEL GHISALLO, 20...
    Issue/Submission Date
    2004-03-16
    2006-12-28
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    • FDA
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    Propranolol Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    4104
    Active
    PROPRANOLOL HCL
    1981-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10278
    Propranolol hydrochloride (producti...
    2009-12-18
    Written Confirmation

    Close WC

    Application Number
    4104
    221MF10278
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PROPRANOLOL HCL
    Propranolol hydrochloride (producti...
    Issue/Submission Date
    1981-02-27
    2009-12-18
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    Torsemide

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    USDMF

    Found USDMF

    15562
    Active
    TORSEMIDE 1016
    2001-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-287 - Rev 03
    Valid
    Torasemide
    2020-01-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15562
    R1-CEP 2006-287 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TORSEMIDE 1016
    Torasemide
    Issue/Submission Date
    2001-07-31
    2020-01-16
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    Amantadine Hydrochloride

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    USDMF

    Found USDMF

    29486
    Active
    AMANTADINE HYDROCHLORIDE
    2015-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29486
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMANTADINE HYDROCHLORIDE
    Issue/Submission Date
    2015-09-01
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    Atenolol

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    USDMF

    Caution USDMF

    7933
    Inactive
    ATENOLOL
    1989-02-20
    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-426 - Rev 01
    Expired
    Atenolol
    2004-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7933
    R0-CEP 2001-426 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    ATENOLOL
    Atenolol
    Issue/Submission Date
    1989-02-20
    2004-10-22
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