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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zentiva

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    01 Agomelatine (1)

    02 Articaine Hydrochloride (1)

    03 Carvedilol (1)

    04 Glibenclamide (1)

    05 Glimepiride (1)

    06 Metipranolol HCl (1)

    07 Metoprolol Succinate (1)

    08 Pentoxifylline (1)

    09 Pheniramine Maleate (1)

    10 Tamsulosin (2)

    11 Tetrahydrozoline (1)

    12 Tramadol Hydrochloride (1)

    13 Zolpidem Tartrate (1)

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    01 Active (2)

    02 Inactive (8)

    03 Blank (4)

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    01 Expired (1)

    02 Valid (5)

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    01 Blank (14)

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    01 WC-0133 (3)

    02 WC-0133A2 (1)

    03 WC-0133A3 (1)

    04 Blank (9)

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    Articaine Hydrochloride

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    USDMF

    Found USDMF

    20287
    Active
    ARTICAINE HYDROCHLORIDE
    2007-02-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-060 - Rev 07
    Valid
    Articaine hydrochloride
    2022-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0133
    Expired
    Articaine Hydrochloride EP/USP at P...
    2020-10-15
    Application Number
    20287
    R1-CEP 2002-060 - Rev 07
    Indian CDSCO WC-0133
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2023-10-14
    Filing Details
    ARTICAINE HYDROCHLORIDE
    Articaine hydrochloride
    Articaine Hydrochloride EP/USP at P...
    Issue/Submission Date
    2007-02-20
    2022-05-17
    2020-10-15
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    Glibenclamide

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    USDMF

    Found USDMF

    18018
    Active
    GLYBURIDE USP (GLIBENCLAMIDE), MILL...
    2005-01-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-223 - Rev 07
    Valid
    Glibenclamide, Milled
    2022-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0133
    Expired
    Glibenclamide EP/Glyburide USP at P...
    2020-10-15
    Application Number
    18018
    R1-CEP 2003-223 - Rev 07
    Indian CDSCO WC-0133
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-10-14
    Filing Details
    GLYBURIDE USP (GLIBENCLAMIDE), MILL...
    Glibenclamide, Milled
    Glibenclamide EP/Glyburide USP at P...
    Issue/Submission Date
    2005-01-21
    2022-02-08
    2020-10-15
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    Pentoxifylline

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    USDMF

    Caution USDMF

    10374
    Inactive
    PENTOXIFYLLINE
    1993-07-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-012 - Rev 04
    Valid
    Pentoxifylline
    2022-05-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0133
    Expired
    Oxpentifylline (Pentoxifylline) EP/...
    2020-10-15
    Application Number
    10374
    R1-CEP 2008-012 - Rev 04
    Indian CDSCO WC-0133
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-10-14
    Filing Details
    PENTOXIFYLLINE
    Pentoxifylline
    Oxpentifylline (Pentoxifylline) EP/...
    Issue/Submission Date
    1993-07-21
    2022-05-06
    2020-10-15
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    Tamsulosin

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    USDMF

    Caution USDMF

    18186
    Inactive
    TAMSULOSIN HYDROCHLORIDE
    2005-03-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-121 - Rev 02
    Valid
    Tamsulosin hydrochloride
    2021-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18186
    R1-CEP 2009-121 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TAMSULOSIN HYDROCHLORIDE
    Tamsulosin hydrochloride
    Issue/Submission Date
    2005-03-14
    2021-12-14
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    Tamsulosin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-469 - Rev 00
    Valid
    Tamsulosin hydrochloride, Ankleshwa...
    2024-04-25
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2023-469 - Rev 00
    Status
    Valid
     
    Filing Details
    Tamsulosin hydrochloride, Ankleshwa...
    Issue/Submission Date
    2024-04-25
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    Agomelatine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0133A3
    Expired
    Agomelatine citric acid co-crystal ...
    2022-07-27
    Application Number
    Indian CDSCO WC-0133A3
    Status
     
    Expired
    2023-10-14
    Filing Details
    Agomelatine citric acid co-crystal ...
    Issue/Submission Date
    2022-07-27
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    Carvedilol

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    USDMF

    Caution USDMF

    16530
    Inactive
    CARVEDILOL
    2003-04-08
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    16530
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CARVEDILOL
    Issue/Submission Date
    2003-04-08
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    Glimepiride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2007-043 - Rev 01
    Expired
    Glimepiride
    2009-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2007-043 - Rev 01
    Status
    Expired
     
    Filing Details
    Glimepiride
    Issue/Submission Date
    2009-03-25
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    Metipranolol HCl

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    USDMF

    Caution USDMF

    11637
    Inactive
    D,L-METIPRANOLOL
    1995-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11637
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    D,L-METIPRANOLOL
    Issue/Submission Date
    1995-08-28
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    Metoprolol Succinate

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    USDMF

    Caution USDMF

    11600
    Inactive
    METOPROLOL SUCCINATE
    1995-08-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11600
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METOPROLOL SUCCINATE
    Issue/Submission Date
    1995-08-15
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