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    01 1,2-Dioxan-3-One (1)

    02 Betaxolol (1)

    03 Bupropion Hydrochloride (1)

    04 Butoconazole Nitrate (1)

    05 Cicletanine Hydrochloride (1)

    06 Ciprofibrate (1)

    07 Cyclobenzaprine (1)

    08 Domperidone (1)

    09 Epinephrine (1)

    10 Fenofibrate (1)

    11 Flutamide (1)

    12 Fluvoxamine (1)

    13 Ipratropium Bromide (1)

    14 Ketoconazole (1)

    15 Lansoprazole (1)

    16 Meloxicam (1)

    17 Milnacipran Hydrochloride (1)

    18 Sevelamer Hydrochloride (1)

    19 Terbinafine Hydrochloride (4)

    20 Terconazole (1)

    21 Blank (1)

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    01 Active (9)

    02 Inactive (6)

    03 Blank (9)

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    01 Valid (4)

    02 Blank (20)

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    01 217MF11174 (1)

    02 218MF10192 (1)

    03 218MF10653 (1)

    04 218MF10765 (1)

    05 224MF10206 (1)

    06 226MF10105 (1)

    07 301MF10056 (1)

    08 303MF10155 (1)

    09 305MF10078 (1)

    10 Blank (15)

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    01 Blank (24)

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    Fenofibrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24032
    Active
    FENOFIBRATE
    2010-08-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-036 - Rev 00
    Valid
    Fenofibrate
    2023-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    24032
    R1-CEP 2016-036 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FENOFIBRATE
    Fenofibrate
    Issue/Submission Date
    2010-08-04
    2023-01-11
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    Flutamide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-159 - Rev 05
    Valid
    Flutamide
    2017-01-11
    Japanese DMF

    Found JDMF

    217MF11174
    Flutamide at Camino de Pliego, No. ...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-159 - Rev 05
    217MF11174
    Status
    Valid
     
    Filing Details
    Flutamide
    Flutamide at Camino de Pliego, No. ...
    Issue/Submission Date
    2017-01-11
    2005-12-12
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    Ketoconazole

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    USDMF

    Found USDMF

    14794
    Active
    KETOCONAZOLE
    2001-01-19
    CEP/COS

    Found CEP/COS

    CEP 2016-102 - Rev 03
    Valid
    Ketoconazole
    2023-10-23
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    14794
    CEP 2016-102 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    KETOCONAZOLE
    Ketoconazole
    Issue/Submission Date
    2001-01-19
    2023-10-23
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    Meloxicam

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    USDMF

    Found USDMF

    24205
    Active
    MELOXICAM
    2010-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10765
    Meloxicam at Camino Viejo de Pliego...
    2006-09-22
    Written Confirmation

    Close WC

    Application Number
    24205
    218MF10765
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELOXICAM
    Meloxicam at Camino Viejo de Pliego...
    Issue/Submission Date
    2010-09-22
    2006-09-22
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    Betaxolol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10078
    Betaxolol Hydrochloride at Camino d...
    2023-07-12
    Written Confirmation

    Close WC

    Application Number
    305MF10078
    Status
     
    Filing Details
    Betaxolol Hydrochloride at Camino d...
    Issue/Submission Date
    2023-07-12
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    Butoconazole Nitrate

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    USDMF

    Found USDMF

    18981
    Active
    BUTOCONAZOLE NITRATE
    2005-11-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    18981
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUTOCONAZOLE NITRATE
    Issue/Submission Date
    2005-11-29
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    Cicletanine Hydrochloride

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    USDMF

    Found USDMF

    24626
    Active
    CICLETANINE HYDROCHLORIDE
    2011-02-11
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    24626
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CICLETANINE HYDROCHLORIDE
    Issue/Submission Date
    2011-02-11
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    Ciprofibrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-112 - Rev 02
    Valid
    Ciprofibrate
    2023-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-112 - Rev 02
    Status
    Valid
     
    Filing Details
    Ciprofibrate
    Issue/Submission Date
    2023-01-20
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    Cyclobenzaprine

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    USDMF

    Found USDMF

    23521
    Active
    CYCLOBENZAPRINE HYDROCHLORIDE
    2010-02-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    23521
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CYCLOBENZAPRINE HYDROCHLORIDE
    Issue/Submission Date
    2010-02-05
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    Domperidone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10653
    Domperidone at Camino Viejo de Plie...
    2006-07-20
    Written Confirmation

    Close WC

    Application Number
    218MF10653
    Status
     
    Filing Details
    Domperidone at Camino Viejo de Plie...
    Issue/Submission Date
    2006-07-20
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