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    01 Carvedilol (2)

    02 Dobutamine Hydrochloride (2)

    03 Ezetimibe (2)

    04 Fingolimod Hydrochloride (1)

    05 Glycopyrronium Bromide (1)

    06 Lamotrigine (2)

    07 Linezolid (1)

    08 Moxifloxacin Hydrochloride (1)

    09 Nebivolol (1)

    10 Pentosan Polysulfate Sodium (1)

    11 Rivaroxaban (1)

    12 Tadalafil (1)

    13 Teneligliptin (1)

    14 Tramadol Hydrochloride (2)

    15 Trimetazidine (2)

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    01 Active (2)

    02 Inactive (1)

    03 Blank (18)

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    01 Expired (1)

    02 Valid (5)

    03 Withdrawn by Holder (1)

    04 Blank (14)

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    01 219MF10300 (1)

    02 229MF10118 (1)

    03 Blank (19)

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    01 WC-0124 (10)

    02 WC-0124A2 (4)

    03 WC-0467 (1)

    04 WC-0467A1 (1)

    05 Blank (5)

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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    20632
    Active
    TRAMADOL HYDROCHLORIDE
    2007-06-26
    CEP/COS

    Found CEP/COS

    CEP 2007-129 - Rev 09
    Valid
    Tramadol hydrochloride, New process
    2023-10-18
    Japanese DMF

    Found JDMF

    229MF10118
    Tramadol hydrochloride at 28A, IDA,...
    2017-07-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Tramadol HCI (Ph. Eur/USP)
    2019-10-31
    Application Number
    20632
    CEP 2007-129 - Rev 09
    229MF10118
    Indian CDSCO WC-0124
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramadol hydrochloride, New process
    Tramadol hydrochloride at 28A, IDA,...
    Tramadol HCI (Ph. Eur/USP)
    Issue/Submission Date
    2007-06-26
    2023-10-18
    2017-07-10
    2019-10-31
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    Lamotrigine

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    USDMF

    Caution USDMF

    25779
    Inactive
    LAMOTRINGINE
    2012-02-14
    CEP/COS

    Found CEP/COS

    CEP 2010-249 - Rev 05
    Valid
    Lamotrigine
    2023-10-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Lamotrigine (USP/Ph. Eur)
    2019-10-31
    Application Number
    25779
    CEP 2010-249 - Rev 05
    Indian CDSCO WC-0124
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LAMOTRINGINE
    Lamotrigine
    Lamotrigine (USP/Ph. Eur)
    Issue/Submission Date
    2012-02-14
    2023-10-18
    2019-10-31
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    Carvedilol

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10300
    Carvedilol at 28A, IDA, Nacharam Hy...
    2007-09-18
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Carvedilol (JP/Ph. Eur)
    2019-10-31
    Application Number
    219MF10300
    Indian CDSCO WC-0124
    Status
     
    Expired
    2022-07-02
    Filing Details
    Carvedilol at 28A, IDA, Nacharam Hy...
    Carvedilol (JP/Ph. Eur)
    Issue/Submission Date
    2007-09-18
    2019-10-31
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    Dobutamine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2020-180 - Rev 03
    Valid
    Dobutamine hydrochloride, Process-2
    2023-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Dobutamine HCI (USP/Ph. Eur)
    2019-10-31
    Application Number
    CEP 2020-180 - Rev 03
    Indian CDSCO WC-0124
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Dobutamine hydrochloride, Process-2
    Dobutamine HCI (USP/Ph. Eur)
    Issue/Submission Date
    2023-10-19
    2019-10-31
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    Moxifloxacin Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-101 - Rev 02
    Valid
    Moxifloxacin hydrochloride, Monohyd...
    2023-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Moxifloxacin HCI (Ph. Eur)
    2019-10-31
    Application Number
    CEP 2014-101 - Rev 02
    Indian CDSCO WC-0124
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Moxifloxacin hydrochloride, Monohyd...
    Moxifloxacin HCI (Ph. Eur)
    Issue/Submission Date
    2023-11-23
    2019-10-31
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    Pentosan Polysulfate Sodium

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    USDMF

    Found USDMF

    34095
    Active
    PENTOSAN POLYSULFATE SODIUM
    2019-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Pentosan Polysulfate Sodium (IH)
    2019-10-31
    Application Number
    34095
    Indian CDSCO WC-0124
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PENTOSAN POLYSULFATE SODIUM
    Pentosan Polysulfate Sodium (IH)
    Issue/Submission Date
    2019-09-13
    2019-10-31
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    Trimetazidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2008-314 - Rev 07
    Valid
    Trimetazidine dihydrochloride
    2023-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0467
    Expired
    Trimetazidine dihydrochloride (EP/B...
    2020-03-26
    Application Number
    CEP 2008-314 - Rev 07
    Indian CDSCO WC-0467
    Status
    Valid
     
    Expired
    2023-03-26
    Filing Details
    Trimetazidine dihydrochloride
    Trimetazidine dihydrochloride (EP/B...
    Issue/Submission Date
    2023-10-19
    2020-03-26
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    Dobutamine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-106 - Rev 03
    Withdrawn by Holder
    Dobutamine hydrochloride
    2021-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124A2
    Expired
    Dobutamine HCl USP
    2020-08-07
    Application Number
    R0-CEP 2016-106 - Rev 03
    Indian CDSCO WC-0124A2
    Status
    Withdrawn by Holder
     
    Expired
    2022-07-02
    Filing Details
    Dobutamine hydrochloride
    Dobutamine HCl USP
    Issue/Submission Date
    2021-02-22
    2020-08-07
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    Tramadol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-132 - Rev 02
    Expired
    Tramadol hydrochloride
    2005-12-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124A2
    Expired
    Tramadol Hydrochloride USP
    2020-08-07
    Application Number
    R0-CEP 2003-132 - Rev 02
    Indian CDSCO WC-0124A2
    Status
    Expired
     
    Expired
    2022-07-02
    Filing Details
    Tramadol hydrochloride
    Tramadol Hydrochloride USP
    Issue/Submission Date
    2005-12-08
    2020-08-07
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    Carvedilol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124A2
    Expired
    Carvedilol JP
    2020-08-07
    Application Number
    Indian CDSCO WC-0124A2
    Status
     
    Expired
    2022-07-02
    Filing Details
    Carvedilol JP
    Issue/Submission Date
    2020-08-07
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