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    Approved Drug Products containing Osimertinib listed in the FDA Orange Book. Original Data : FDA Website

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    Bora Pharmaceuticals- Making success more certain.

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    Osimertinib

    ACTIVE PHARMA INGREDIENTS

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    02 2ZYDUS PHARMS USA INC

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    ASTRAZENECA

    United Kingdom
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    ASTRAZENECA

    United Kingdom
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    RLD : Yes

    TE Code :

    OSIMERTINIB MESYLATE

    Brand Name : TAGRISSO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 40MG BASE

    Approval Date : 2015-11-13

    Application Number : 208065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    ASTRAZENECA

    United Kingdom
    Luxepack
    Not Confirmed
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    ASTRAZENECA

    United Kingdom
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    Luxepack
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    OSIMERTINIB MESYLATE

    Brand Name : TAGRISSO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 80MG BASE

    Approval Date : 2015-11-13

    Application Number : 208065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

    Portfolio PDF

    Product Web Link

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    Website

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    03

    ZYDUS PHARMS USA INC

    U.S.A
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    ZYDUS PHARMS USA INC

    U.S.A
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    • EDQM
    • WHO-GMP
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    RLD :

    TE Code :

    OSIMERTINIB MESYLATE

    Brand Name : OSIMERTINIB MESYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 40MG

    Approval Date :

    Application Number : 214263

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    04

    ZYDUS PHARMS USA INC

    U.S.A
    Luxepack
    Not Confirmed
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    ZYDUS PHARMS USA INC

    U.S.A
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    Luxepack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD :

    TE Code :

    OSIMERTINIB MESYLATE

    Brand Name : OSIMERTINIB MESYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 80MG

    Approval Date :

    Application Number : 214263

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF