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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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    F.I.S. FABBRICA ITALIANA SINTETICI

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    F.I.S. Fabbrica Italiana Sintetici
    Italy Flag
    Country
    Country
    Italy
    Address
    Address
    Viale Milano, 26, 36075 Montecchio, Maggiore, Vicenza (Italy)
    Telephone
    Telephone
    +39-044-470-8011
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.fisvi.com/it
    Linkedin
    Linkedin
    https://www.linkedin.com/company/f-i-s---fabbrica-italiana-sintetici/
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    Twitter

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    • FDA
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    Chlordiazepoxide

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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

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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Carbamazepine

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    USDMF

    Found USDMF

    6641
    Active
    CARBAMAZEPINE
    1986-10-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-271 - Rev 05
    Valid
    Carbamazepine
    2022-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6641
    R1-CEP 2003-271 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CARBAMAZEPINE
    Carbamazepine
    Issue/Submission Date
    1986-10-20
    2022-02-25
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    • FDA
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    Clomiphene Citrate

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    USDMF

    Found USDMF

    5674
    Active
    CLOMIPHENE CITRATE
    1984-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10082
    Clomiphene citrate at Viale Milano ...
    2014-05-02
    Written Confirmation

    Close WC

    Application Number
    5674
    226MF10082
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLOMIPHENE CITRATE
    Clomiphene citrate at Viale Milano ...
    Issue/Submission Date
    1984-12-20
    2014-05-02
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    Diltiazem Hydrochloride

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    USDMF

    Found USDMF

    7600
    Active
    DILTIAZEM HYDROCHLORIDE
    1988-07-18
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-036 - Rev 07
    Valid
    Diltiazem hydrochloride
    2022-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7600
    R1-CEP 1998-036 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DILTIAZEM HYDROCHLORIDE
    Diltiazem hydrochloride
    Issue/Submission Date
    1988-07-18
    2022-03-15
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    • FDA
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    24901
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    2011-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-110 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2022-06-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24901
    R1-CEP 2015-110 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2011-04-20
    2022-06-21
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    Flurazepam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    5282
    Active
    FLURAZEPAM HCl
    1984-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10792
    Flurazepam hydrochloride at Viale M...
    2006-10-06
    Written Confirmation

    Close WC

    Application Number
    5282
    218MF10792
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLURAZEPAM HCl
    Flurazepam hydrochloride at Viale M...
    Issue/Submission Date
    1984-02-27
    2006-10-06
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    • FDA
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    Fosfomycin

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    USDMF

    Found USDMF

    10891
    Active
    FOSFOMYCIN TROMETAMOL
    1994-04-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-289 - Rev 00
    Valid
    Fosfomycin trometamol
    2022-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10891
    R1-CEP 2015-289 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FOSFOMYCIN TROMETAMOL
    Fosfomycin trometamol
    Issue/Submission Date
    1994-04-28
    2022-04-19
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    • FDA
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    Gabapentin

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    USDMF

    Found USDMF

    14024
    Active
    GABAPENTIN
    1999-03-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-173 - Rev 00
    Valid
    Gabapentin
    2019-08-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14024
    R1-CEP 2013-173 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GABAPENTIN
    Gabapentin
    Issue/Submission Date
    1999-03-19
    2019-08-27
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    25205
    Active
    IMATINIB MESYLATE (BETA FORM)
    2011-07-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-058 - Rev 00
    Valid
    Imatinib mesilate
    2022-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25205
    R1-CEP 2016-058 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IMATINIB MESYLATE (BETA FORM)
    Imatinib mesilate
    Issue/Submission Date
    2011-07-26
    2022-08-04
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    Indomethacin

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    USDMF

    Found USDMF

    3136
    Active
    INDOMETHACIN
    1978-01-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-256 - Rev 03
    Valid
    Indometacin, Micronised, non-micron...
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3136
    R1-CEP 2009-256 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    INDOMETHACIN
    Indometacin, Micronised, non-micron...
    Issue/Submission Date
    1978-01-23
    2023-01-25
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    Midazolam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-383 - Rev 01
    Valid
    Midazolam
    2022-10-12
    Japanese DMF

    Found JDMF

    229MF10108
    Midazolam at Viale Milano 26 36075 ...
    2017-06-21
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-383 - Rev 01
    229MF10108
    Status
    Valid
     
    Filing Details
    Midazolam
    Midazolam at Viale Milano 26 36075 ...
    Issue/Submission Date
    2022-10-12
    2017-06-21
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    Nifedipine

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    USDMF

    Found USDMF

    6339
    Active
    NIFEDIPINE USP
    1986-03-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-055 - Rev 02
    Valid
    Nifedipine
    2018-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6339
    R1-CEP 2009-055 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NIFEDIPINE USP
    Nifedipine
    Issue/Submission Date
    1986-03-14
    2018-07-17
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    Nitrazepam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-286 - Rev 03
    Valid
    Nitrazepam
    2014-02-24
    Japanese DMF

    Found JDMF

    217MF10544
    Nitrazepam at Viale Milano 26 36075...
    2005-09-09
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-286 - Rev 03
    217MF10544
    Status
    Valid
     
    Filing Details
    Nitrazepam
    Nitrazepam at Viale Milano 26 36075...
    Issue/Submission Date
    2014-02-24
    2005-09-09
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    Nitrofurantoin

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    USDMF

    Found USDMF

    453
    Active
    NITROFURANTOIN & NITROFURANTOIN MAC...
    1965-07-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-178 - Rev 00
    Valid
    Nitrofurantoin, Macrocrystals
    2021-09-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    453
    R0-CEP 2019-178 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NITROFURANTOIN & NITROFURANTOIN MAC...
    Nitrofurantoin, Macrocrystals
    Issue/Submission Date
    1965-07-13
    2021-09-29
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    Nitrofurantoin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13266
    Active
    NITROFURANTOIN MONOHYDRATE
    1998-10-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-181 - Rev 00
    Valid
    Nitrofurantoin
    2021-09-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13266
    R0-CEP 2019-181 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NITROFURANTOIN MONOHYDRATE
    Nitrofurantoin
    Issue/Submission Date
    1998-10-05
    2021-09-29
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    Oxazepam

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    5208
    Active
    OXAZEPAM
    1984-01-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-014 - Rev 01
    Valid
    Oxazepam
    2019-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5208
    R1-CEP 2011-014 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXAZEPAM
    Oxazepam
    Issue/Submission Date
    1984-01-09
    2019-10-31
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    Oxcarbazepine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16597
    Active
    OXCARBAZEPINE
    2003-05-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-091 - Rev 00
    Valid
    Oxcarbazepine, Process M
    2021-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16597
    R1-CEP 2015-091 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXCARBAZEPINE
    Oxcarbazepine, Process M
    Issue/Submission Date
    2003-05-15
    2021-09-02
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    Pentazocine

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Found USDMF

    3776
    Active
    PENTAZOCINE HCI
    1980-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10106
    Pentazocine hydrochloride at Viale ...
    2009-06-02
    Written Confirmation

    Close WC

    Application Number
    3776
    221MF10106
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENTAZOCINE HCI
    Pentazocine hydrochloride at Viale ...
    Issue/Submission Date
    1980-03-07
    2009-06-02
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    Pentazocine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30214
    Active
    PENTAZOCINE
    2016-04-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10848
    Pentazocine at Viale Milano 26 3607...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    30214
    217MF10848
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENTAZOCINE
    Pentazocine at Viale Milano 26 3607...
    Issue/Submission Date
    2016-04-20
    2005-11-01
    ASK
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    Progesterone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22096
    Active
    PROGESTERONE
    2008-11-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-234 - Rev 01
    Valid
    Progesterone
    2019-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22096
    R1-CEP 2010-234 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PROGESTERONE
    Progesterone
    Issue/Submission Date
    2008-11-20
    2019-11-29
    ASK
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    • FDA
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    Quetiapine Hemifumarate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    21358
    Active
    QUETIAPINE FUMARATE
    2008-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10124
    Quetiapine fumarate at Viale Milano...
    2011-07-28
    Written Confirmation

    Close WC

    Application Number
    21358
    223MF10124
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine fumarate at Viale Milano...
    Issue/Submission Date
    2008-02-21
    2011-07-28
    ASK
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    • FDA
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    Sulindac

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    6187
    Active
    SULINDAC
    1986-02-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10202
    Sulindac at Viale Milano 26 36075 M...
    2008-09-19
    Written Confirmation

    Close WC

    Application Number
    6187
    220MF10202
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SULINDAC
    Sulindac at Viale Milano 26 36075 M...
    Issue/Submission Date
    1986-02-11
    2008-09-19
    ASK
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    • FDA
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    Testosterone Propionate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33240
    Active
    TESTOSTERONE PROPIONATE
    2018-10-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-258 - Rev 00
    Valid
    Testosterone propionate
    2020-05-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33240
    R0-CEP 2018-258 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TESTOSTERONE PROPIONATE
    Testosterone propionate
    Issue/Submission Date
    2018-10-16
    2020-05-07
    ASK
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    your Marketing & Sales content
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    • FDA
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    Entacapone

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    23984
    Active
    ENTACAPONE
    2010-07-13
    CEP/COS

    Caution CEP/COS

    R1-CEP 2014-221 - Rev 00
    Withdrawn by Holder
    Entacapone
    2021-12-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23984
    R1-CEP 2014-221 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ENTACAPONE
    Entacapone
    Issue/Submission Date
    2010-07-13
    2021-12-03
    ASK
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    Olopatadine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    23240
    Inactive
    OLOPATADINE HYDROCHLORIDE
    2009-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10009
    Olopatadine hydrochloride at Viale ...
    2011-01-21
    Written Confirmation

    Close WC

    Application Number
    23240
    223MF10009
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OLOPATADINE HYDROCHLORIDE
    Olopatadine hydrochloride at Viale ...
    Issue/Submission Date
    2009-10-30
    2011-01-21
    ASK
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    • FDA
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    Oxcarbazepine

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    18521
    Inactive
    OXCARBAZEPINE
    2005-06-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-249 - Rev 00
    Valid
    Oxcarbazepine, Process A
    2022-04-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18521
    R1-CEP 2016-249 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXCARBAZEPINE
    Oxcarbazepine, Process A
    Issue/Submission Date
    2005-06-30
    2022-04-21
    ASK
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    • FDA
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    Bazedoxifene

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    15025
    Active
    TSE 424 ACETATE
    2000-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15025
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TSE 424 ACETATE
    Issue/Submission Date
    2000-08-31
    ASK
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    • FDA
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    Clobazam

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    24728
    Active
    CLOBAZAM
    2011-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24728
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLOBAZAM
    Issue/Submission Date
    2011-02-28
    ASK
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    Eletriptan Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24528
    Active
    ELETRIPTAN HYDROBROMIDE
    2010-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24528
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ELETRIPTAN HYDROBROMIDE
    Issue/Submission Date
    2010-12-29
    ASK
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    • FDA
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    Estazolam

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    11784
    Active
    ESTAZOLAM
    1995-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11784
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESTAZOLAM
    Issue/Submission Date
    1995-12-20
    ASK
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      Fluvastatin Sodium

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      18911
      Active
      FLUVASTATIN SODIUM HYDRATE USP
      2005-10-11
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      18911
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Filing Details
      FLUVASTATIN SODIUM HYDRATE USP
      Issue/Submission Date
      2005-10-11
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      • FDA
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      Imatinib Mesylate

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      25206
      Active
      IMATINIB MESYLATE (ALPHA FORM)
      2011-07-27
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      25206
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      IMATINIB MESYLATE (ALPHA FORM)
      Issue/Submission Date
      2011-07-27
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      Indomethacin Sodium

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      29441
      Active
      INDOMETHACIN SODIUM
      2015-09-30
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      29441
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      INDOMETHACIN SODIUM
      Issue/Submission Date
      2015-09-30
      ASK
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        Lenalidomide

        PDF Supplier PDF
        URL Supplier Web Content
        See all info for this product

        See Less

        USDMF

        Found USDMF

        27116
        Active
        LENALIDOMIDE
        2013-06-04
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27116
        Status
        Active
        Fees Unpaid
        Reviewed
         
        Filing Details
        LENALIDOMIDE
        Issue/Submission Date
        2013-06-04
        ASK
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        Midazolam Hydrochloride

        PDF Supplier PDF
        URL Supplier Web Content
        See all info for this product

        See Less

        USDMF

        Found USDMF

        25204
        Active
        MIDAZOLAM HCI
        2011-08-01
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        25204
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        MIDAZOLAM HCI
        Issue/Submission Date
        2011-08-01
        ASK
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        Nebivolol

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        22735
        Active
        NEBIVOLOL HYDROCHLORIDE
        2009-03-31
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        22735
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        NEBIVOLOL HYDROCHLORIDE
        Issue/Submission Date
        2009-03-31
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        Nitrofurantoin

        PDF Supplier PDF
        URL Supplier Web Content
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        See Less

        USDMF

        Found USDMF

        21887
        Active
        NITROFURANTOIN MONOHYDRATE (CODE 10...
        2008-08-05
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        21887
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        NITROFURANTOIN MONOHYDRATE (CODE 10...
        Issue/Submission Date
        2008-08-05
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        • FDA
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        Olopatadine Hydrochloride

        PDF Supplier PDF
        URL Supplier Web Content
        See all info for this product

        See Less

        USDMF

        Found USDMF

        26297
        Active
        OLOPATADINE HYDROCHLORIDE
        2012-08-02
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        26297
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        OLOPATADINE HYDROCHLORIDE
        Issue/Submission Date
        2012-08-02
        ASK
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        • FDA
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        Prasterone Acetate

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        27340
        Active
        PRASTERONE ACETATE
        2013-09-20
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27340
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        PRASTERONE ACETATE
        Issue/Submission Date
        2013-09-20
        ASK
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          Thalidomide

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Found USDMF

          21806
          Active
          THALIDOMIDE
          2008-07-28
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          21806
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Filing Details
          THALIDOMIDE
          Issue/Submission Date
          2008-07-28
          ASK
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          • FDA
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          ENAMINE AMIDE (FIS0448)

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Found USDMF

          18957
          Active
          ENAMINE AMIDE (FIS0448)
          2005-11-09
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          18957
          Status
          Active
          Fees Paid
          N/A
           
          Filing Details
          ENAMINE AMIDE (FIS0448)
          Issue/Submission Date
          2005-11-09
          ASK
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