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

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    01 Acamprosate Calcium (1)

    02 Bendazac (1)

    03 Benzydamine (1)

    04 Dapiprazole Hydrochloride (1)

    05 Erdosteine (1)

    06 Etoperidone Hydrochloride (1)

    07 Ibopamine (1)

    08 Lonidamine (1)

    09 Metaxalone (1)

    10 Mirtazapine (1)

    11 Oxolamine Citrate (1)

    12 Oxolamine Phosphate (1)

    13 Trazodone Hydrochloride (2)

    14 Blank (3)

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    01 Active (4)

    02 Inactive (6)

    03 Blank (7)

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    01 Valid (3)

    02 Blank (14)

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    01 Blank (17)

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    01 Blank (17)

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    Trazodone Hydrochloride

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    USDMF

    Found USDMF

    3328
    Active
    TRAZODONE HCL
    1978-06-14
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-511 - Rev 00
    Valid
    Trazodone hydrochloride
    2023-08-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    3328
    R0-CEP 2021-511 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRAZODONE HCL
    Trazodone hydrochloride
    Issue/Submission Date
    1978-06-14
    2023-08-28
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    Acamprosate Calcium

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    USDMF

    Found USDMF

    21348
    Active
    ACAMPROSATE CALCIUM
    2008-02-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    21348
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ACAMPROSATE CALCIUM
    Issue/Submission Date
    2008-02-20
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    Benzydamine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-203 - Rev 01
    Valid
    Benzydamine hydrochloride
    2024-01-17
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2021-203 - Rev 01
    Status
    Valid
     
    Filing Details
    Benzydamine hydrochloride
    Issue/Submission Date
    2024-01-17
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    Dapiprazole Hydrochloride

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    USDMF

    Found USDMF

    4334
    Active
    DAPIPRAZOLE HYDROCHLORIDE
    1981-10-28
    CEP/COS

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    Japanese DMF

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    Application Number
    4334
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAPIPRAZOLE HYDROCHLORIDE
    Issue/Submission Date
    1981-10-28
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    Metaxalone

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    USDMF

    Found USDMF

    15100
    Active
    METAXALONE
    2000-10-19
    CEP/COS

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    Japanese DMF

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    Application Number
    15100
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METAXALONE
    Issue/Submission Date
    2000-10-19
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    Trazodone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2023-098 - Rev 00
    Valid
    Trazodone hydrochloride, Process II
    2023-08-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2023-098 - Rev 00
    Status
    Valid
     
    Filing Details
    Trazodone hydrochloride, Process II
    Issue/Submission Date
    2023-08-28
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    Etoperidone Hydrochloride

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    USDMF

    Caution USDMF

    8372
    Inactive
    ETOPERIDONE HYDROCHLORIDE
    1989-11-22
    CEP/COS

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    Japanese DMF

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    Application Number
    8372
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ETOPERIDONE HYDROCHLORIDE
    Issue/Submission Date
    1989-11-22
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    Lonidamine

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    USDMF

    Caution USDMF

    4314
    Inactive
    LONIDAMINE
    1981-11-09
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    4314
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LONIDAMINE
    Issue/Submission Date
    1981-11-09
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    Mirtazapine

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    USDMF

    Caution USDMF

    16014
    Inactive
    MIRTAZAPINE
    2002-06-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    16014
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MIRTAZAPINE
    Issue/Submission Date
    2002-06-20
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    FACILITIES IN APRILIA, ITALY

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    USDMF

    Caution USDMF

    2652
    Inactive
    FACILITIES IN APRILIA, ITALY
    1976-04-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    2652
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITIES IN APRILIA, ITALY
    Issue/Submission Date
    1976-04-06
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