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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Erregierre SpA

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    Erregierre SpA
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    Italy
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    Address
    via Francesco Baracca, 1924060 San Paolo D'Argon (BG)
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    Telephone
    +39 035 958383
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    enquiries@pharmacompass.com
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    • FDA
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    Mesalazine

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    USDMF

    Found USDMF

    13883
    Active
    MESALAMINE USP-EP
    1998-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-049 - Rev 04
    Valid
    Mesalazine
    2019-10-03
    Japanese DMF

    Found JDMF

    221MF10064
    Mesalazine at VIA F. BARACCA 19-240...
    2009-03-26
    Written Confirmation

    Close WC

    Application Number
    13883
    R1-CEP 2004-049 - Rev 04
    221MF10064
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP-EP
    Mesalazine
    Mesalazine at VIA F. BARACCA 19-240...
    Issue/Submission Date
    1998-12-03
    2019-10-03
    2009-03-26
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    Mesalazine

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    USDMF

    Found USDMF

    24889
    Active
    MESALAMINE USP - PH.EUR. (HIGH DENS...
    2011-04-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-322 - Rev 00
    Valid
    Mesalazine, High density
    2017-10-30
    Japanese DMF

    Found JDMF

    219MF10065
    Mesalazine at VIA F. BARACCA 19-240...
    2007-03-05
    Written Confirmation

    Close WC

    Application Number
    24889
    R1-CEP 2011-322 - Rev 00
    219MF10065
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP - PH.EUR. (HIGH DENS...
    Mesalazine, High density
    Mesalazine at VIA F. BARACCA 19-240...
    Issue/Submission Date
    2011-04-26
    2017-10-30
    2007-03-05
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    • FDA
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    Raloxifene Hydrochloride

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    USDMF

    Found USDMF

    15932
    Active
    RALOXIFENE HYDROCHLORIDE
    2002-04-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-205 - Rev 00
    Valid
    Raloxifene hydrochloride
    2017-09-06
    Japanese DMF

    Found JDMF

    226MF10007
    Raloxifene Hydrochloride at VIA F. ...
    2014-01-08
    Written Confirmation

    Close WC

    Application Number
    15932
    R1-CEP 2010-205 - Rev 00
    226MF10007
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RALOXIFENE HYDROCHLORIDE
    Raloxifene hydrochloride
    Raloxifene Hydrochloride at VIA F. ...
    Issue/Submission Date
    2002-04-10
    2017-09-06
    2014-01-08
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    • FDA
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-117 - Rev 02
    Valid
    Ambroxol hydrochloride
    2020-07-10
    Japanese DMF

    Found JDMF

    219MF10010
    Outsiders regulations ambroxol hydr...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-117 - Rev 02
    219MF10010
    Status
    Valid
     
    Filing Details
    Ambroxol hydrochloride
    Outsiders regulations ambroxol hydr...
    Issue/Submission Date
    2020-07-10
    2007-01-18
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    • FDA
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    Bifonazole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-241 - Rev 00
    Valid
    Bifonazole
    2019-12-05
    Japanese DMF

    Found JDMF

    221MF10279
    Bifonazole (production only) at Via...
    2009-12-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-241 - Rev 00
    221MF10279
    Status
    Valid
     
    Filing Details
    Bifonazole
    Bifonazole (production only) at Via...
    Issue/Submission Date
    2019-12-05
    2009-12-18
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    • FDA
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    Bisacodyl

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    USDMF

    Found USDMF

    14947
    Active
    BISACODYL USP-EP
    2000-06-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-233 - Rev 00
    Valid
    Bisacodyl, Micronised
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14947
    R0-CEP 2020-233 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BISACODYL USP-EP
    Bisacodyl, Micronised
    Issue/Submission Date
    2000-06-29
    2022-03-01
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    • FDA
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    Ciclopirox

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    USDMF

    Found USDMF

    16353
    Active
    CICLOPIROX USP-EP
    2002-12-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-210 - Rev 03
    Valid
    Ciclopirox
    2019-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16353
    R1-CEP 2002-210 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CICLOPIROX USP-EP
    Ciclopirox
    Issue/Submission Date
    2002-12-30
    2019-03-07
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    Ciclopirox Olamine

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    USDMF

    Found USDMF

    16352
    Active
    CICLOPIROX OLAMINE USP-PH.EUR.
    2003-01-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-065 - Rev 04
    Valid
    Ciclopirox olamine
    2022-08-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16352
    R1-CEP 2002-065 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CICLOPIROX OLAMINE USP-PH.EUR.
    Ciclopirox olamine
    Issue/Submission Date
    2003-01-02
    2022-08-29
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    • FDA
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    Clotrimazole

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    USDMF

    Found USDMF

    6324
    Active
    CLOTRIMAZOLE USP-EP
    1986-03-01
    CEP/COS

    Found CEP/COS

    CEP 2005-176 - Rev 03
    Valid
    Clotrimazole
    2024-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6324
    CEP 2005-176 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLOTRIMAZOLE USP-EP
    Clotrimazole
    Issue/Submission Date
    1986-03-01
    2024-01-31
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    • FDA
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    Isoconazole Nitrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-282 - Rev 01
    Valid
    Isoconazole nitrate, Standard and m...
    2023-10-18
    Japanese DMF

    Found JDMF

    217MF10587
    Nitric acid isoconazole at VIA F. B...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    CEP 2014-282 - Rev 01
    217MF10587
    Status
    Valid
     
    Filing Details
    Isoconazole nitrate, Standard and m...
    Nitric acid isoconazole at VIA F. B...
    Issue/Submission Date
    2023-10-18
    2005-09-14
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    • FDA
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    Nisoldipine

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    USDMF

    Found USDMF

    16215
    Active
    NISOLDIPINE
    2002-10-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10589
    Nisoldipine at VIA F. BARACCA 19-24...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    16215
    217MF10589
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NISOLDIPINE
    Nisoldipine at VIA F. BARACCA 19-24...
    Issue/Submission Date
    2002-10-22
    2005-09-14
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    • FDA
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    24331
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2010-10-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-364 - Rev 00
    Valid
    Pramipexole dihydrochloride monohyd...
    2017-03-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24331
    R1-CEP 2010-364 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2010-10-25
    2017-03-06
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    • FDA
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    Rivastigmine

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    USDMF

    Found USDMF

    25871
    Active
    RIVASTIGMINE
    2011-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10192
    Rivastigmine at VIA F. BARACCA 19-2...
    2016-10-05
    Written Confirmation

    Close WC

    Application Number
    25871
    228MF10192
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RIVASTIGMINE
    Rivastigmine at VIA F. BARACCA 19-2...
    Issue/Submission Date
    2011-12-22
    2016-10-05
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    • FDA
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    Ticlopidine

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    USDMF

    Found USDMF

    11968
    Active
    TICLOPIDINE HYDROCHLORIDE
    1996-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-081 - Rev 02
    Valid
    Ticlopidine hydrochloride
    2017-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11968
    R1-CEP 1999-081 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TICLOPIDINE HYDROCHLORIDE
    Ticlopidine hydrochloride
    Issue/Submission Date
    1996-05-17
    2017-07-17
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    • FDA
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    Gabapentin

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    USDMF

    Caution USDMF

    15513
    Inactive
    GABAPENTIN
    2001-07-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-210 - Rev 00
    Valid
    Gabapentin
    2018-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15513
    R1-CEP 2012-210 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GABAPENTIN
    Gabapentin
    Issue/Submission Date
    2001-07-03
    2018-09-27
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    • FDA
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    Oxiconazole Nitrate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    15403
    Inactive
    OXICONAZOLE NITRATE
    2001-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10204
    Nitrate oxiconazole at VIA F. BARAC...
    2008-09-29
    Written Confirmation

    Close WC

    Application Number
    15403
    220MF10204
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXICONAZOLE NITRATE
    Nitrate oxiconazole at VIA F. BARAC...
    Issue/Submission Date
    2001-04-26
    2008-09-29
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    • FDA
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    Amisulpride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-202 - Rev 03
    Valid
    Amisulpride
    2017-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-202 - Rev 03
    Status
    Valid
     
    Filing Details
    Amisulpride
    Issue/Submission Date
    2017-12-06
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    • FDA
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    Aripiprazole

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    USDMF

    Found USDMF

    18706
    Active
    ARIPIPRAZOLE USP-EP
    2005-08-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18706
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE USP-EP
    Issue/Submission Date
    2005-08-15
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    • FDA
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    Bupropion Hydrochloride

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    USDMF

    Found USDMF

    11054
    Active
    BUPROPION HYDROCHLORIDE USP
    1994-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11054
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPROPION HYDROCHLORIDE USP
    Issue/Submission Date
    1994-08-30
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    • FDA
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    Butenafine Hydrochloride

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    USDMF

    Found USDMF

    18707
    Active
    BUTENAFINE HYDROCHLORIDE
    2005-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18707
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUTENAFINE HYDROCHLORIDE
    Issue/Submission Date
    2005-08-16
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    • FDA
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    Camostat

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10164
    Duck Stat mesylate at VIA F. BARACC...
    2017-08-22
    Written Confirmation

    Close WC

    Application Number
    229MF10164
    Status
     
    Filing Details
    Duck Stat mesylate at VIA F. BARACC...
    Issue/Submission Date
    2017-08-22
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    Camostatum

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11176
    \"Japan-station\" mesylate camostat...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    217MF11176
    Status
     
    Filing Details
    \"Japan-station\" mesylate camostat...
    Issue/Submission Date
    2005-12-12
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    • FDA
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    Carprofen

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-003 - Rev 01
    Valid
    Carprofen for veterinary use, Micro...
    2023-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-003 - Rev 01
    Status
    Valid
     
    Filing Details
    Carprofen for veterinary use, Micro...
    Issue/Submission Date
    2023-07-13
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    Fluoxetine Hydrochloride

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    USDMF

    Found USDMF

    10837
    Active
    FLUOXETINE HYDROCHLORIDE USP-EP
    1994-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10837
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUOXETINE HYDROCHLORIDE USP-EP
    Issue/Submission Date
    1994-03-28
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    • FDA
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    Gepirone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14297
    Active
    GEPIRONE HYDROCHLORIDE
    1999-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14297
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GEPIRONE HYDROCHLORIDE
    Issue/Submission Date
    1999-07-09
    ASK
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    Ingavirin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31634
    Active
    IMIDAZOLYL ETHANAMIDE PENTANDIOIC A...
    2017-04-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31634
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IMIDAZOLYL ETHANAMIDE PENTANDIOIC A...
    Issue/Submission Date
    2017-04-07
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    Miconazole Nitrate

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    USDMF

    Found USDMF

    6870
    Active
    MICONAZOLE NITRATE
    1987-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6870
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICONAZOLE NITRATE
    Issue/Submission Date
    1987-03-05
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    Nabumetone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19243
    Active
    NABUMETONE USP
    2006-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19243
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NABUMETONE USP
    Issue/Submission Date
    2006-03-07
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    NAFTIFINE HCL

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14711
    Active
    NAFTIFINE HYDROCHLORIDE USP
    2000-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14711
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NAFTIFINE HYDROCHLORIDE USP
    Issue/Submission Date
    2000-02-15
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    Ozagrel Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10232
    OZAGREL HYDROCHLORIDE at VIA F. BAR...
    2008-11-17
    Written Confirmation

    Close WC

    Application Number
    220MF10232
    Status
     
    Filing Details
    OZAGREL HYDROCHLORIDE at VIA F. BAR...
    Issue/Submission Date
    2008-11-17
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    Ozagrel Sodium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10586
    Sodium ozagrel at VIA F. BARACCA 19...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    217MF10586
    Status
     
    Filing Details
    Sodium ozagrel at VIA F. BARACCA 19...
    Issue/Submission Date
    2005-09-14
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    P-Trifluoromethylbenzyl Bromide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25932
    Active
    N-[4-(TRIFLUOROMETHYL)BENZYL]-4-MET...
    2012-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25932
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    N-[4-(TRIFLUOROMETHYL)BENZYL]-4-MET...
    Issue/Submission Date
    2012-03-27
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    Propafenone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13010
    Active
    PROPAFENONE HYDROCHLORIDE USP-EP
    1998-06-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13010
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PROPAFENONE HYDROCHLORIDE USP-EP
    Issue/Submission Date
    1998-06-01
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    Rivastigmine Tartrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20227
    Active
    RIVASTIGMINE TARTRATE
    2007-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20227
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVASTIGMINE TARTRATE
    Issue/Submission Date
    2007-01-29
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    Sulconazole Nitrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14972
    Active
    SULCONAZOLE NITRATE USP
    2000-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14972
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SULCONAZOLE NITRATE USP
    Issue/Submission Date
    2000-07-31
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    Tioconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    12613
    Active
    TIOCONAZOLE
    1997-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12613
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TIOCONAZOLE
    Issue/Submission Date
    1997-08-04
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    Tolterodine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20483
    Active
    TOLTERODINE TARTRATE
    2007-04-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20483
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOLTERODINE TARTRATE
    Issue/Submission Date
    2007-04-24
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    Urapidil Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10127
    URAAPIDIL at VIA F. BARACCA 19-2406...
    2022-08-31
    Written Confirmation

    Close WC

    Application Number
    304MF10127
    Status
     
    Filing Details
    URAAPIDIL at VIA F. BARACCA 19-2406...
    Issue/Submission Date
    2022-08-31
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    • FDA
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    Zileuton

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26995
    Active
    ZILEUTON USP
    2013-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26995
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ZILEUTON USP
    Issue/Submission Date
    2013-03-15
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    Celecoxib

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19652
    Inactive
    CELECOXIB USP-EP
    2006-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19652
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CELECOXIB USP-EP
    Issue/Submission Date
    2006-08-03
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    Chenodeoxycholic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21692
    Inactive
    CHENODEOXYCHOLIC ACID EP
    2008-06-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21692
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHENODEOXYCHOLIC ACID EP
    Issue/Submission Date
    2008-06-07
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    Gabapentin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    17351
    Inactive
    GABAPENTIN
    2004-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17351
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GABAPENTIN
    Issue/Submission Date
    2004-04-29
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    Isoxsuprine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    12511
    Inactive
    ISOXSUPRINE HYDROCHLORIDE USP
    1997-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12511
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ISOXSUPRINE HYDROCHLORIDE USP
    Issue/Submission Date
    1997-05-19
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    Nabumetone

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

    See Less

    USDMF

    Caution USDMF

    14600
    Inactive
    NABUMETONE
    1999-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14600
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NABUMETONE
    Issue/Submission Date
    1999-11-30
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    • FDA
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    Oxaprozin

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

    See Less

    USDMF

    Caution USDMF

    14059
    Inactive
    OXAPROZIN JP
    1999-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14059
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXAPROZIN JP
    Issue/Submission Date
    1999-04-05
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20342
    Inactive
    PANTOPRAZOLE SODIUM
    2007-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20342
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PANTOPRAZOLE SODIUM
    Issue/Submission Date
    2007-03-01
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    Pioglitazone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19343
    Inactive
    PIOGLITAZONE HYDROCHLORIDE
    2006-04-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19343
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE
    Issue/Submission Date
    2006-04-04
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    Risperidone

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    19370
    Inactive
    RISPERIDONE PH. EUR.
    2006-04-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19370
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RISPERIDONE PH. EUR.
    Issue/Submission Date
    2006-04-07
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    Sotalol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    13083
    Inactive
    SOTALOL HYDROCHLORIDE
    1998-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13083
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SOTALOL HYDROCHLORIDE
    Issue/Submission Date
    1998-07-21
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    Trazodone Hydrochloride

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

    See Less

    USDMF

    Caution USDMF

    14047
    Inactive
    TRAZODONE HYDROCHLORIDE
    1999-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14047
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TRAZODONE HYDROCHLORIDE
    Issue/Submission Date
    1999-03-29
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