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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alkaloida Chemical Company Zrt

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    Alkaloida Chemical Company Zrt

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    01 Buspirone (1)

    02 Buspirone Hydrochloride (1)

    03 Codeine (1)

    04 Codeine Phosphate (1)

    05 Dihydrocodeine Tartrate (1)

    06 Hydroxychloroquine Sulphate (2)

    07 Mexiletine (1)

    08 Noscapine (1)

    09 Noscapine Hydrochloride (1)

    10 Oxycodone Hydrochloride (1)

    11 Phenobarbital (1)

    12 Phenobarbital Sodium (1)

    13 Pholcodine (1)

    14 Topiramate (1)

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    01 Active (3)

    02 Inactive (5)

    03 Blank (7)

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    01 Expired (1)

    02 Valid (8)

    03 Blank (6)

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    01 Blank (15)

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    01 Blank (15)

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    Phenobarbital

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    USDMF

    Found USDMF

    4642
    Active
    PHENOBARBITAL USP
    1982-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-132 - Rev 03
    Valid
    Phenobarbital
    2021-12-08
    Japanese DMF

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    Application Number
    4642
    R1-CEP 2009-132 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PHENOBARBITAL USP
    Phenobarbital
    Issue/Submission Date
    1982-09-01
    2021-12-08
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    Phenobarbital Sodium

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    USDMF

    Found USDMF

    34598
    Active
    PHENOBARBITAL SODIUM, USP
    2020-03-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-501 - Rev 00
    Valid
    Phenobarbital Sodium
    2023-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    34598
    R0-CEP 2021-501 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PHENOBARBITAL SODIUM, USP
    Phenobarbital Sodium
    Issue/Submission Date
    2020-03-10
    2023-04-04
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    Codeine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-142 - Rev 00
    Valid
    Codeine monohydrate
    2022-12-01
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    Application Number
    R0-CEP 2022-142 - Rev 00
    Status
    Valid
     
    Filing Details
    Codeine monohydrate
    Issue/Submission Date
    2022-12-01
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    Codeine Phosphate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-199 - Rev 01
    Valid
    Codeine phosphate hemihydrate
    2021-02-16
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    Application Number
    R1-CEP 2006-199 - Rev 01
    Status
    Valid
     
    Filing Details
    Codeine phosphate hemihydrate
    Issue/Submission Date
    2021-02-16
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    Dihydrocodeine Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-225 - Rev 02
    Valid
    Dihydrocodeine hydrogen tartrate
    2020-08-21
    Japanese DMF

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    Application Number
    R1-CEP 2009-225 - Rev 02
    Status
    Valid
     
    Filing Details
    Dihydrocodeine hydrogen tartrate
    Issue/Submission Date
    2020-08-21
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    Hydroxychloroquine Sulphate

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    USDMF

    Found USDMF

    23582
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    2010-03-25
    CEP/COS

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    Application Number
    23582
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Issue/Submission Date
    2010-03-25
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    Noscapine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-067 - Rev 00
    Valid
    Noscapine
    2019-04-23
    Japanese DMF

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    Application Number
    R0-CEP 2018-067 - Rev 00
    Status
    Valid
     
    Filing Details
    Noscapine
    Issue/Submission Date
    2019-04-23
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    Noscapine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2017-222 - Rev 00
    Valid
    Noscapine Hydrochloride Hydrate
    2019-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2017-222 - Rev 00
    Status
    Valid
     
    Filing Details
    Noscapine Hydrochloride Hydrate
    Issue/Submission Date
    2019-04-04
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    Pholcodine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2016-268 - Rev 01
    Valid
    Pholcodine monohydrate
    2024-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    CEP 2016-268 - Rev 01
    Status
    Valid
     
    Filing Details
    Pholcodine monohydrate
    Issue/Submission Date
    2024-01-25
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    Buspirone

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    USDMF

    Caution USDMF

    12135
    Inactive
    BUSPIRONE BASE
    1996-09-16
    CEP/COS

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    Application Number
    12135
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BUSPIRONE BASE
    Issue/Submission Date
    1996-09-16
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