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    01 Dexmedetomidine Hydrochloride (2)

    02 Droperidol (1)

    03 Flecainide (1)

    04 Meldonium (1)

    05 Oxytocin (1)

    06 Tegafur (1)

    07 Ursodeoxycholic Acid (2)

    08 Xylazine Hydrochloride (1)

    09 Zopiclone (1)

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    01 Active (2)

    02 Blank (9)

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    01 Valid (6)

    02 Withdrawn by Holder (2)

    03 Blank (3)

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    01 217MF10470 (1)

    02 220MF10090 (1)

    03 228MF10234 (1)

    04 303MF10179 (1)

    05 Blank (7)

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    01 Blank (11)

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    • FDA
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    Droperidol

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    USDMF

    Found USDMF

    22975
    Active
    DROPERIDOL USP
    2009-07-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-164 - Rev 02
    Valid
    Droperidol
    2020-06-12
    Japanese DMF

    Found JDMF

    220MF10090
    Droperidol at 53 Krustpils Street, ...
    2008-03-28
    Written Confirmation

    Close WC

    Application Number
    22975
    R1-CEP 2012-164 - Rev 02
    220MF10090
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DROPERIDOL USP
    Droperidol
    Droperidol at 53 Krustpils Street, ...
    Issue/Submission Date
    2009-07-16
    2020-06-12
    2008-03-28
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    Oxytocin

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    USDMF

    Found USDMF

    21777
    Active
    OXYTOCIN, USP
    2008-06-27
    CEP/COS

    Found CEP/COS

    CEP 2002-200 - Rev 05
    Valid
    Oxytocin
    2024-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21777
    CEP 2002-200 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXYTOCIN, USP
    Oxytocin
    Issue/Submission Date
    2008-06-27
    2024-01-09
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    Dexmedetomidine Hydrochloride

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    303MF10179
    Dexmedetomidine Hydrochloide at 53 ...
    2021-12-15
    Written Confirmation

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    Application Number
    303MF10179
    Status
     
    Filing Details
    Dexmedetomidine Hydrochloide at 53 ...
    Issue/Submission Date
    2021-12-15
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    Dexmedetomidine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10234
    Hydrochloric acid dexmedetomidine a...
    2016-12-26
    Written Confirmation

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    Application Number
    228MF10234
    Status
     
    Filing Details
    Hydrochloric acid dexmedetomidine a...
    Issue/Submission Date
    2016-12-26
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    Meldonium

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-089 - Rev 01
    Valid
    Meldonium dihydrate
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-089 - Rev 01
    Status
    Valid
     
    Filing Details
    Meldonium dihydrate
    Issue/Submission Date
    2022-05-19
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    Tegafur

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10470
    Ftorafur at 53 Krustpils Street, Ri...
    2005-08-24
    Written Confirmation

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    Application Number
    217MF10470
    Status
     
    Filing Details
    Ftorafur at 53 Krustpils Street, Ri...
    Issue/Submission Date
    2005-08-24
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    Ursodeoxycholic Acid

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2012-057 - Rev 00
    Valid
    Ursodeoxycholic acid, Micronised, n...
    2019-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-057 - Rev 00
    Status
    Valid
     
    Filing Details
    Ursodeoxycholic acid, Micronised, n...
    Issue/Submission Date
    2019-03-26
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    Xylazine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-081 - Rev 00
    Valid
    Xylazine hydrochloride for veterina...
    2015-06-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-081 - Rev 00
    Status
    Valid
     
    Filing Details
    Xylazine hydrochloride for veterina...
    Issue/Submission Date
    2015-06-04
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    Zopiclone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-280 - Rev 03
    Valid
    Zopiclone
    2019-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-280 - Rev 03
    Status
    Valid
     
    Filing Details
    Zopiclone
    Issue/Submission Date
    2019-04-12
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    Flecainide

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2008-080 - Rev 01
    Withdrawn by Holder
    Flecainide acetate
    2011-06-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2008-080 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Flecainide acetate
    Issue/Submission Date
    2011-06-01
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