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    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    Baloxavir Marboxil

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    01

    F. Hoffmann-La Roche

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    F. Hoffmann-La Roche

    Switzerland
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    ACS Fall 2025
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET

    Dosage Strength : 80MG

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    Approval Date :

    Application Number : 2524163

    Regulatory Info :

    Registration Country : Canada

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    02

    Genentech

    U.S.A
    ACS Fall 2025
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    Genentech

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    Regulatory Info : DISCN

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2018-10-24

    Application Number : 210854

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 40MG

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    Approval Date : 2018-10-24

    Application Number : 210854

    Regulatory Info : RX

    Registration Country : USA

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    04

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 2021-03-18

    Application Number : 210854

    Regulatory Info : RX

    Registration Country : USA

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    05

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 2MG/ML

    Packaging :

    Approval Date : 2020-11-23

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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    06

    Genentech

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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 30MG/PACKET

    Packaging :

    Approval Date : 2025-05-30

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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    07

    Genentech

    U.S.A
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    U.S.A
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    ACS Fall 2025
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 40MG/PACKET

    Packaging :

    Approval Date : 2025-05-30

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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