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    Denosumab

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    01 2AMGEN

    02 2BIOCON BIOLOGICS INC

    03 2CELLTRION INC

    04 2FRESENIUS KABI USA LLC

    05 2HIKMA PHARMACEUTICALS USA INC

    06 4SAMSUNG BIOEPIS CO LTD

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    01

    AMGEN

    U.S.A
    CTAD25
    Not Confirmed
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    AMGEN

    U.S.A
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    CTAD25
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    RLD :

    TE Code :

    DENOSUMAB

    Brand Name : PROLIA

    Dosage Form : INJECTABLE; SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Approval Date :

    Application Number : 125320

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    02

    AMGEN

    U.S.A
    CTAD25
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    AMGEN

    U.S.A
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    CTAD25
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    RLD :

    TE Code :

    DENOSUMAB

    Brand Name : XGEVA

    Dosage Form : INJECTABLE; SUBCUTANEOUS

    Dosage Strength : 70MG/ML

    Approval Date :

    Application Number : 125320

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    RLD :

    TE Code :

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    03

    FRESENIUS KABI USA LLC

    U.S.A
    CTAD25
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    FRESENIUS KABI USA LLC

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    RLD :

    TE Code :

    DENOSUMAB-BNHT

    Brand Name : BOMYNTRA

    Dosage Form : INJECTION

    Dosage Strength : 120MG/1.7ML (70 MG/ML)

    Approval Date :

    Application Number : 761398

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    TE Code :

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    04

    FRESENIUS KABI USA LLC

    U.S.A
    CTAD25
    Not Confirmed
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    05

    SAMSUNG BIOEPIS CO LTD

    South Korea
    CTAD25
    Not Confirmed
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    SAMSUNG BIOEPIS CO LTD

    South Korea
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    CTAD25
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    RLD :

    TE Code :

    DENOSUMAB-DSSB

    Brand Name : OSPOMYV

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Approval Date :

    Application Number : 761392

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    SAMSUNG BIOEPIS CO LTD

    South Korea
    CTAD25
    Not Confirmed
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    SAMSUNG BIOEPIS CO LTD

    South Korea
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    CTAD25
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    RLD :

    TE Code :

    DENOSUMAB-DSSB

    Brand Name : XBRYK

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 70MG/ML

    Approval Date :

    Application Number : 761392

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    SAMSUNG BIOEPIS CO LTD

    South Korea
    CTAD25
    Not Confirmed
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    SAMSUNG BIOEPIS CO LTD

    South Korea
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    CTAD25
    Not Confirmed
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    RLD :

    TE Code :

    DENOSUMAB-DSSB

    Brand Name : DENOSUMAB-DSSB

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Approval Date :

    Application Number : 761392

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    08

    SAMSUNG BIOEPIS CO LTD

    South Korea
    CTAD25
    Not Confirmed
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    SAMSUNG BIOEPIS CO LTD

    South Korea
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    CTAD25
    Not Confirmed
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    RLD :

    TE Code :

    DENOSUMAB-DSSB

    Brand Name : DENOSUMAB-DSSB

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 70MG/ML

    Approval Date :

    Application Number : 761392

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    09

    SANDOZ INC

    Switzerland
    CTAD25
    Not Confirmed
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    SANDOZ INC

    Switzerland
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    CTAD25
    Not Confirmed
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    RLD :

    TE Code :

    DENOSUMAB-BBDZ

    Brand Name : JUBBONTI

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Approval Date :

    Application Number : 761362

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    10

    SANDOZ INC

    Switzerland
    CTAD25
    Not Confirmed
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    SANDOZ INC

    Switzerland
    arrow
    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD :

    TE Code :

    DENOSUMAB-BBDZ

    Brand Name : WYOST

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 120MG/1.7ML (70MG/ML)

    Approval Date :

    Application Number : 761362

    RX/OTC/DISCN :

    RLD :

    TE Code :

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