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

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    01 Disopyramide (1)

    02 Divalproex Sodium (2)

    03 Dorzolamide Hydrochloride (1)

    04 Esomeprazole Sodium (1)

    05 Estetrol (1)

    06 Racecadotril (1)

    07 Roluperidone (1)

    08 Blank (1)

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    01 Active (7)

    02 Blank (2)

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    01 Valid (2)

    02 Blank (7)

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    01 Blank (9)

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    01 Blank (9)

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    • FDA
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    Disopyramide

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    USDMF

    Found USDMF

    23852
    Active
    DISOPYRAMIDE PHOSPHATE
    2010-05-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    23852
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DISOPYRAMIDE PHOSPHATE
    Issue/Submission Date
    2010-05-24
    Seqens Company Banner

    Cophex 2024

    Not Confirmed

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    • FDA
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    Divalproex Sodium

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    USDMF

    Found USDMF

    5678
    Active
    VALPROIC ACID
    1985-01-18
    CEP/COS

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    Japanese DMF

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    Application Number
    5678
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VALPROIC ACID
    Issue/Submission Date
    1985-01-18
    Seqens Company Banner

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    Not Confirmed

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    Divalproex Sodium

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    USDMF

    Found USDMF

    14646
    Active
    DIVALPROEX SODIUM
    1999-12-27
    CEP/COS

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    Application Number
    14646
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIVALPROEX SODIUM
    Issue/Submission Date
    1999-12-27
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    Dorzolamide Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2012-023 - Rev 01
    Valid
    Dorzolamide hydrochloride
    2020-07-30
    Japanese DMF

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    Application Number
    R1-CEP 2012-023 - Rev 01
    Status
    Valid
     
    Filing Details
    Dorzolamide hydrochloride
    Issue/Submission Date
    2020-07-30
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    Cophex 2024

    Not Confirmed

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    Esomeprazole Sodium

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    USDMF

    Found USDMF

    28375
    Active
    ESOMEPRAZOLE SODIUM
    2014-06-09
    CEP/COS

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    Application Number
    28375
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESOMEPRAZOLE SODIUM
    Issue/Submission Date
    2014-06-09
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    Cophex 2024

    Not Confirmed

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    Estetrol

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    USDMF

    Found USDMF

    34214
    Active
    Estetrol Monohydrate
    2019-11-27
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34214
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    Estetrol Monohydrate
    Issue/Submission Date
    2019-11-27
    Seqens Company Banner

    Cophex 2024

    Not Confirmed

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    • FDA
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    Racecadotril

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2014-373 - Rev 01
    Valid
    Racecadotril
    2021-08-06
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2014-373 - Rev 01
    Status
    Valid
     
    Filing Details
    Racecadotril
    Issue/Submission Date
    2021-08-06
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    Cophex 2024

    Not Confirmed

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    Roluperidone

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    USDMF

    Found USDMF

    36423
    Active
    ROLUPERIDONE HYDROCHLORIDE
    2021-11-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    36423
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ROLUPERIDONE HYDROCHLORIDE
    Issue/Submission Date
    2021-11-22
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    Not Confirmed

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    MIPRI

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    USDMF

    Found USDMF

    24680
    Active
    MIPRI
    2011-02-23
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    24680
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MIPRI
    Issue/Submission Date
    2011-02-23
    Seqens Company Banner

    Cophex 2024

    Not Confirmed

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