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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by F.i.s. Fabbrica Italiana Sintetici

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    01 2,5-Dibromo-1,4-Dimethyl-1H-Imidazole (1)

    02 4-Des-Dimethylaminotetracycline (1)

    03 Acetylcysteine (1)

    04 Allopurinol (1)

    05 Bazedoxifene (1)

    06 Benzylhydrazine (1)

    07 Bromazepam (1)

    08 Carbamazepine (1)

    09 Chlordiazepoxide (2)

    10 Chlordiazepoxide HCl (1)

    11 Clobazam (2)

    12 Clomiphene Citrate (2)

    13 Clonazepam (1)

    14 Clorazepate Dipotassium (1)

    15 Clotrimazole (1)

    16 Desipramine Hydrochloride (1)

    17 Diazepam (1)

    18 Diltiazem Hydrochloride (2)

    19 Dorzolamide Hydrochloride (2)

    20 Dutasteride (1)

    21 Eletriptan Hydrobromide (1)

    22 Entacapone (1)

    23 Erlotinib Hydrochloride (1)

    24 Esomeprazole Magnesium (3)

    25 Estazolam (1)

    26 Flunitrazepam (2)

    27 Flurazepam (1)

    28 Flurazepam Monohydrochloride (1)

    29 Fluvastatin Sodium (2)

    30 Fosfomycin (1)

    31 Furazolidone (1)

    32 Furosemide (1)

    33 Gabapentin (1)

    34 Imatinib Mesylate (3)

    35 Indomethacin (1)

    36 Indomethacin Sodium (1)

    37 Lansoprazole (1)

    38 Lenalidomide (1)

    39 Lorazepam (1)

    40 Lubiprostone (1)

    41 Midazolam (1)

    42 Midazolam Hydrochloride (1)

    43 Nebivolol (1)

    44 Nelarabine (1)

    45 Nifedipine (1)

    46 Nilotinib (1)

    47 Nitrazepam (1)

    48 Nitrofurantoin (3)

    49 Olopatadine Hydrochloride (3)

    50 Oxazepam (1)

    51 Oxcarbazepine (2)

    52 Pentazocine (2)

    53 Piroxicam (1)

    54 Prasterone Acetate (1)

    55 Prazepam (1)

    56 Progesterone (1)

    57 Propofol (1)

    58 Quazepam (1)

    59 Quetiapine Hemifumarate (2)

    60 Rifaximin (1)

    61 Safinamide Mesylate (1)

    62 Sertraline Hydrochloride (1)

    63 Sitagliptin Phosphate (2)

    64 Solifenacin Succinate (2)

    65 Sulindac (1)

    66 Temazepam (1)

    67 Terbinafine (1)

    68 Testosterone Cypionate (1)

    69 Testosterone Propionate (1)

    70 Tetrazepam (2)

    71 Thalidomide (1)

    72 Tramazoline Hydrochloride Monohydrate (1)

    73 Triamterene (1)

    74 Trimethobenzamide HCl (1)

    75 Trimethoprim (2)

    76 Blank (4)

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    01 Active (52)

    02 Inactive (33)

    03 Blank (16)

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    01 Valid (33)

    02 Withdrawn by Holder (4)

    03 Blank (64)

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    01 217MF10541 (1)

    02 217MF10542 (1)

    03 217MF10543 (1)

    04 217MF10544 (1)

    05 217MF10848 (1)

    06 217MF10849 (1)

    07 218MF10197 (1)

    08 218MF10792 (1)

    09 220MF10166 (1)

    10 220MF10202 (1)

    11 221MF10106 (1)

    12 221MF10167 (1)

    13 222MF10163 (1)

    14 223MF10009 (1)

    15 223MF10124 (1)

    16 224MF10199 (1)

    17 226MF10001 (1)

    18 226MF10082 (1)

    19 226MF10165 (1)

    20 229MF10108 (1)

    21 230MF10165 (1)

    22 305MF10116 (1)

    23 Blank (79)

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    01 Blank (101)

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    Chlordiazepoxide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    467
    Active
    CHLORDIAZEPOXIDE HCL
    1962-02-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-423 - Rev 02
    Valid
    Chlordiazepoxide
    2014-02-24
    Japanese DMF

    Found JDMF

    222MF10163
    Chlordiazepoxide at Viale Milano 26...
    2010-06-02
    Written Confirmation

    Close WC

    Application Number
    467
    R1-CEP 2001-423 - Rev 02
    222MF10163
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CHLORDIAZEPOXIDE HCL
    Chlordiazepoxide
    Chlordiazepoxide at Viale Milano 26...
    Issue/Submission Date
    1962-02-15
    2014-02-24
    2010-06-02
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    Clonazepam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7505
    Active
    CLONAZEPAM
    1988-06-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-037 - Rev 01
    Valid
    Clonazepam, Non-micronised, microni...
    2022-11-23
    Japanese DMF

    Found JDMF

    217MF10543
    Clonazepam at Viale Milano 26 36075...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    7505
    R1-CEP 2013-037 - Rev 01
    217MF10543
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLONAZEPAM
    Clonazepam, Non-micronised, microni...
    Clonazepam at Viale Milano 26 36075...
    Issue/Submission Date
    1988-06-01
    2022-11-23
    2005-09-09
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    Clotrimazole

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    USDMF

    Found USDMF

    7548
    Active
    CLOTRIMAZOLE
    1988-06-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-326 - Rev 02
    Valid
    Clotrimazole, Standard and micronis...
    2022-06-22
    Japanese DMF

    Found JDMF

    221MF10167
    Clotrimazole at Viale Milano 26 360...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    7548
    R1-CEP 2008-326 - Rev 02
    221MF10167
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLOTRIMAZOLE
    Clotrimazole, Standard and micronis...
    Clotrimazole at Viale Milano 26 360...
    Issue/Submission Date
    1988-06-21
    2022-06-22
    2009-07-30
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    Diazepam

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    USDMF

    Found USDMF

    3164
    Active
    DIAZEPAM
    1978-02-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-272 - Rev 03
    Valid
    Diazepam
    2023-04-17
    Japanese DMF

    Found JDMF

    217MF10542
    Diazepam at Viale Milano 26 36075 M...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    3164
    R1-CEP 2003-272 - Rev 03
    217MF10542
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DIAZEPAM
    Diazepam
    Diazepam at Viale Milano 26 36075 M...
    Issue/Submission Date
    1978-02-28
    2023-04-17
    2005-09-09
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    Furosemide

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    USDMF

    Found USDMF

    3513
    Active
    FUROSEMIDE
    1979-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-005 - Rev 03
    Valid
    Furosemide
    2014-02-24
    Japanese DMF

    Found JDMF

    217MF10541
    Furosemide at Viale Milano 26 36075...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    3513
    R1-CEP 2004-005 - Rev 03
    217MF10541
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FUROSEMIDE
    Furosemide
    Furosemide at Viale Milano 26 36075...
    Issue/Submission Date
    1979-03-08
    2014-02-24
    2005-09-09
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    Lorazepam

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    USDMF

    Found USDMF

    5027
    Active
    LORAZEPAM
    1983-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-243 - Rev 00
    Valid
    Lorazepam
    2022-12-16
    Japanese DMF

    Found JDMF

    217MF10849
    Lorazepam at Viale Milano 26 36075 ...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    5027
    R1-CEP 2016-243 - Rev 00
    217MF10849
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LORAZEPAM
    Lorazepam
    Lorazepam at Viale Milano 26 36075 ...
    Issue/Submission Date
    1983-05-17
    2022-12-16
    2005-11-01
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    Rifaximin

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    USDMF

    Found USDMF

    15635
    Active
    RIFAXIMIN
    2001-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-085 - Rev 01
    Valid
    Rifaximin, Form α
    2018-10-12
    Japanese DMF

    Found JDMF

    226MF10165
    Rifaximin at Viale Milano 26 36075 ...
    2014-09-01
    Written Confirmation

    Close WC

    Application Number
    15635
    R1-CEP 2010-085 - Rev 01
    226MF10165
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RIFAXIMIN
    Rifaximin, Form α
    Rifaximin at Viale Milano 26 36075 ...
    Issue/Submission Date
    2001-09-20
    2018-10-12
    2014-09-01
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    Dorzolamide Hydrochloride

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    USDMF

    Caution USDMF

    20740
    Inactive
    DORZOLAMIDE HYDROCHLORIDE
    2007-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-308 - Rev 03
    Valid
    Dorzolamide hydrochloride
    2019-03-25
    Japanese DMF

    Found JDMF

    230MF10165
    Dorzolamide Hydrochloride at Viale ...
    2018-12-04
    Written Confirmation

    Close WC

    Application Number
    20740
    R1-CEP 2008-308 - Rev 03
    230MF10165
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DORZOLAMIDE HYDROCHLORIDE
    Dorzolamide hydrochloride
    Dorzolamide Hydrochloride at Viale ...
    Issue/Submission Date
    2007-07-27
    2019-03-25
    2018-12-04
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    Acetylcysteine

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    USDMF

    Found USDMF

    5091
    Active
    ACETYLCYSTEINE, USP
    1983-07-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-070 - Rev 09
    Valid
    Acetylcysteine
    2021-07-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5091
    R1-CEP 1996-070 - Rev 09
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ACETYLCYSTEINE, USP
    Acetylcysteine
    Issue/Submission Date
    1983-07-04
    2021-07-23
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    Bromazepam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-034 - Rev 02
    Valid
    Bromazepam
    2014-02-24
    Japanese DMF

    Found JDMF

    220MF10166
    Bromazepam at Viale Milano 26 36075...
    2008-07-24
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-034 - Rev 02
    220MF10166
    Status
    Valid
     
    Filing Details
    Bromazepam
    Bromazepam at Viale Milano 26 36075...
    Issue/Submission Date
    2014-02-24
    2008-07-24
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