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

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    Zentiva
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    U kabelovny 529/16, Dolni Mecholupy 102 00 Prague 10
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    +420 267 241 111
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    • FDA
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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

    Close JDMF

    Written Confirmation

    Close WC

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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    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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    • FDA
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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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    • FDA
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    Pheniramine Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0133A2
    Expired
    Pheniramine Maleate BP at Plot No 3...
    2021-02-26
    Application Number
    Indian CDSCO WC-0133A2
    Status
     
    Expired
    2023-10-14
    Filing Details
    Pheniramine Maleate BP at Plot No 3...
    Issue/Submission Date
    2021-02-26
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    • FDA
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    Tetrahydrozoline

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    USDMF

    Caution USDMF

    15191
    Inactive
    TETRAHYDROZOLINE HYDROCHLORIDE USP
    2000-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15191
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TETRAHYDROZOLINE HYDROCHLORIDE USP
    Issue/Submission Date
    2000-12-15
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    • FDA
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    Tramadol Hydrochloride

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    USDMF

    Caution USDMF

    12404
    Inactive
    TRAMADOL HYDROCHLORIDE
    1997-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12404
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Issue/Submission Date
    1997-02-28
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    • FDA
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    Zolpidem Tartrate

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    USDMF

    Caution USDMF

    16624
    Inactive
    ZOLPIDEM TARTRATE
    2003-06-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16624
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZOLPIDEM TARTRATE
    Issue/Submission Date
    2003-06-02
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