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    Amisulpride

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    USDMF

    Found USDMF

    31672
    Active
    AMISULPRIDE
    2017-07-11
    CEP/COS

    Found CEP/COS

    CEP 2019-051 - Rev 03
    Valid
    Amisulpride, Process 2
    2023-11-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31672
    CEP 2019-051 - Rev 03
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMISULPRIDE
    Amisulpride, Process 2
    Issue/Submission Date
    2017-07-11
    2023-11-21
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    Brinzolamide

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    USDMF

    Found USDMF

    25478
    Active
    BRINZOLAMIDE (MICRONIZED, MICRONIZE...
    2011-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10086
    Brinzolamide at Via Delle Arti 33, ...
    2019-04-11
    Written Confirmation

    Close WC

    Application Number
    25478
    231MF10086
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    BRINZOLAMIDE (MICRONIZED, MICRONIZE...
    Brinzolamide at Via Delle Arti 33, ...
    Issue/Submission Date
    2011-11-07
    2019-04-11
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    Epinastine Hydrochloride

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    USDMF

    Found USDMF

    21830
    Active
    EPINASTINE HYDROCHLORIDE
    2008-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10231
    Epinastine hydrochloride at Via Del...
    2014-12-08
    Written Confirmation

    Close WC

    Application Number
    21830
    226MF10231
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    EPINASTINE HYDROCHLORIDE
    Epinastine hydrochloride at Via Del...
    Issue/Submission Date
    2008-07-28
    2014-12-08
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    Fluorescein

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    USDMF

    Found USDMF

    29144
    Active
    FLUORESCEIN SODIUM
    2015-03-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-121 - Rev 00
    Valid
    Fluorescein Sodium
    2023-07-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29144
    R1-CEP 2017-121 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    FLUORESCEIN SODIUM
    Fluorescein Sodium
    Issue/Submission Date
    2015-03-05
    2023-07-03
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    Methylene Blue

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    USDMF

    Found USDMF

    36307
    Active
    METHYLENE BLUE
    2021-12-02
    CEP/COS

    Found CEP/COS

    CEP 2022-296 - Rev 00
    Valid
    Methylthioninium chloride hydrate
    2023-12-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36307
    CEP 2022-296 - Rev 00
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    METHYLENE BLUE
    Methylthioninium chloride hydrate
    Issue/Submission Date
    2021-12-02
    2023-12-18
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    Metoclopramide Hydrochloride

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    USDMF

    Found USDMF

    32884
    Active
    METOCLOPRAMIDE HCL
    2018-06-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-304 - Rev 00
    Valid
    Metoclopramide Hydrochloride monohy...
    2021-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32884
    R1-CEP 2015-304 - Rev 00
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    METOCLOPRAMIDE HCL
    Metoclopramide Hydrochloride monohy...
    Issue/Submission Date
    2018-06-19
    2021-05-20
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    Minoxidil

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    USDMF

    Found USDMF

    17270
    Active
    MINOXIDIL
    2004-03-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-392 - Rev 01
    Valid
    Minoxidil
    2023-06-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17270
    R0-CEP 2020-392 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    MINOXIDIL
    Minoxidil
    Issue/Submission Date
    2004-03-23
    2023-06-02
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    Sulpiride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-074 - Rev 03
    Valid
    Sulpiride
    2023-03-13
    Japanese DMF

    Found JDMF

    218MF10084
    Japan Bureau Sulpiride (for manufac...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-074 - Rev 03
    218MF10084
    Status
    Valid
     
    Filing Details
    Sulpiride
    Japan Bureau Sulpiride (for manufac...
    Issue/Submission Date
    2023-03-13
    2006-01-27
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    Tiapride Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-003 - Rev 00
    Valid
    Tiapride hydrochloride
    2024-01-19
    Japanese DMF

    Found JDMF

    227MF10074
    Tiapride hydrochloride at Via Delle...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    CEP 2023-003 - Rev 00
    227MF10074
    Status
    Valid
     
    Filing Details
    Tiapride hydrochloride
    Tiapride hydrochloride at Via Delle...
    Issue/Submission Date
    2024-01-19
    2015-03-12
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    Amisulpride

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    USDMF

    Caution USDMF

    25523
    Inactive
    AMISULPRIDE
    2011-11-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-215 - Rev 02
    Valid
    Amisulpride
    2021-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25523
    R1-CEP 2009-215 - Rev 02
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMISULPRIDE
    Amisulpride
    Issue/Submission Date
    2011-11-24
    2021-06-16
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    Bepotastine

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    USDMF

    Found USDMF

    27465
    Active
    BEPOTASTINE BESILATE
    2013-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27465
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    BEPOTASTINE BESILATE
    Issue/Submission Date
    2013-08-27
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    Brinzolamide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10040
    Brinzolamide at Via Delle Arti 33, ...
    2017-02-15
    Written Confirmation

    Close WC

    Application Number
    229MF10040
    Status
     
    Filing Details
    Brinzolamide at Via Delle Arti 33, ...
    Issue/Submission Date
    2017-02-15
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    Diacerein

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2017-148 - Rev 03
    Valid
    Diacerein
    2024-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2017-148 - Rev 03
    Status
    Valid
     
    Filing Details
    Diacerein
    Issue/Submission Date
    2024-03-26
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    Fluorescein

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    USDMF

    Found USDMF

    39362
    Active
    FLUORESCEIN SODIUM
    2024-02-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    FLUORESCEIN SODIUM
    Issue/Submission Date
    2024-02-01
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    Indocyanine Green

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    USDMF

    Found USDMF

    38104
    Active
    INDOCYANINE GREEN
    2023-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38104
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    INDOCYANINE GREEN
    Issue/Submission Date
    2023-10-31
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    Risperidone

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    USDMF

    Found USDMF

    35974
    Active
    RISPERIDONE
    2021-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35974
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    RISPERIDONE
    Issue/Submission Date
    2021-06-28
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    Tiapride Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10085
    Outsiders regulations hydrochloric ...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    218MF10085
    Status
     
    Filing Details
    Outsiders regulations hydrochloric ...
    Issue/Submission Date
    2006-01-27
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    Risperidone

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25683
    Inactive
    RISPERIDONE
    2011-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25683
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    RISPERIDONE
    Issue/Submission Date
    2011-12-22
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    Alizapride Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Binimetinib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Bortezomib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Bromopride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Encorafenib

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Gliquidone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Isavuconazonium Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Isosulfan Blue

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Lenalidomide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Levosulpiride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Metoclopramide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Paliperidone Palmitate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Pipoxolan Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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