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    28 A, IDA Nacharam Hyderabad 500 076, India
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    • FDA
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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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    • FDA
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    Carvedilol

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    USDMF

    Close USDMF

    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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Carvedilol

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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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    • FDA
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    Ezetimibe

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Ezetimibe (IH)
    2019-10-31
    Application Number
    Indian CDSCO WC-0124
    Status
     
    Expired
    2022-07-02
    Filing Details
    Ezetimibe (IH)
    Issue/Submission Date
    2019-10-31
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    Ezetimibe

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0467A1
    Expired
    Ezetimibe USP
    2020-09-18
    Application Number
    Indian CDSCO WC-0467A1
    Status
     
    Expired
    2023-03-25
    Filing Details
    Ezetimibe USP
    Issue/Submission Date
    2020-09-18
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    • FDA
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    Glycopyrronium Bromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Glycopyrronium Bromide EP
    2019-10-31
    Application Number
    Indian CDSCO WC-0124
    Status
     
    Expired
    2022-07-02
    Filing Details
    Glycopyrronium Bromide EP
    Issue/Submission Date
    2019-10-31
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    Lamotrigine

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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
    Lamotrigine USP
    2020-08-07
    Application Number
    Indian CDSCO WC-0124A2
    Status
     
    Expired
    2022-07-02
    Filing Details
    Lamotrigine USP
    Issue/Submission Date
    2020-08-07
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    • FDA
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    Nebivolol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Nebivolol Hydrochloride (IH)
    2019-10-31
    Application Number
    Indian CDSCO WC-0124
    Status
     
    Expired
    2022-07-02
    Filing Details
    Nebivolol Hydrochloride (IH)
    Issue/Submission Date
    2019-10-31
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    Trimetazidine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0124
    Expired
    Trimetazidine Di HCI (Ph. Eur)
    2019-10-31
    Application Number
    Indian CDSCO WC-0124
    Status
     
    Expired
    2022-07-02
    Filing Details
    Trimetazidine Di HCI (Ph. Eur)
    Issue/Submission Date
    2019-10-31
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    • FDA
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    Fingolimod Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    • FDA
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    Linezolid

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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
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    Rivaroxaban

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Close WC

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    Status
     
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    Tadalafil

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Teneligliptin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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