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

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    Umeclidinium

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    01

    GLAXOSMITHKLINE

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GLAXOSMITHKLINE

    United Kingdom
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    AAPS 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

    Brand Name : ANORO ELLIPTA

    Dosage Form : POWDER;INHALATION

    Dosage Strength : EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

    Approval Date : 2013-12-18

    Application Number : 203975

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    GLAXO GRP ENGLAND

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GLAXO GRP ENGLAND

    United Kingdom
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    AAPS 2024
    Not Confirmed
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    • WHO-GMP
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    RLD : Yes

    TE Code :

    UMECLIDINIUM BROMIDE

    Brand Name : INCRUSE ELLIPTA

    Dosage Form : POWDER;INHALATION

    Dosage Strength : EQ 0.0625MG BASE/INH

    Approval Date : 2014-04-30

    Application Number : 205382

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    GLAXOSMITHKLINE

    United Kingdom
    AAPS 2024
    Not Confirmed
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    United Kingdom
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    AAPS 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

    Brand Name : TRELEGY ELLIPTA

    Dosage Form : POWDER;INHALATION

    Dosage Strength : 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

    Approval Date : 2017-09-18

    Application Number : 209482

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    GLAXOSMITHKLINE

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GLAXOSMITHKLINE

    United Kingdom
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    AAPS 2024
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    RLD : Yes

    TE Code :

    FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

    Brand Name : TRELEGY ELLIPTA

    Dosage Form : POWDER;INHALATION

    Dosage Strength : 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

    Approval Date : 2020-09-09

    Application Number : 209482

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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