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    01 2AIZANT

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    03 13ASTRAZENECA AB

    04 2GLENMARK GENERICS

    05 2HETERO LABS UNIT III

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    01

    ASTRAZENECA AB

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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN

    Brand Name : FARXIGA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date : 2014-01-08

    Application Number : 202293

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    ASTRAZENECA AB

    United Kingdom
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    ASTRAZENECA AB

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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN

    Brand Name : FARXIGA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2014-01-08

    Application Number : 202293

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    ASTRAZENECA AB

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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : XIGDUO XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;500MG

    Approval Date : 2014-10-29

    Application Number : 205649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    ASTRAZENECA AB

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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : XIGDUO XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG;1GM

    Approval Date : 2014-10-29

    Application Number : 205649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    05

    ASTRAZENECA AB

    United Kingdom
    American Pharma Summit
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    ASTRAZENECA AB

    United Kingdom
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    American Pharma Summit
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : XIGDUO XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;500MG

    Approval Date : 2014-10-29

    Application Number : 205649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    06

    ASTRAZENECA AB

    United Kingdom
    American Pharma Summit
    Not Confirmed
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    ASTRAZENECA AB

    United Kingdom
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    American Pharma Summit
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : XIGDUO XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG;1GM

    Approval Date : 2014-10-29

    Application Number : 205649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    07

    ASTRAZENECA AB

    United Kingdom
    American Pharma Summit
    Not Confirmed
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    ASTRAZENECA AB

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    American Pharma Summit
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : XIGDUO XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 2.5MG;1GM

    Approval Date : 2017-07-28

    Application Number : 205649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    08

    ASTRAZENECA AB

    United Kingdom
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

    Brand Name : QTERN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG;EQ 5MG BASE

    Approval Date : 2017-02-27

    Application Number : 209091

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    09

    ASTRAZENECA AB

    United Kingdom
    American Pharma Summit
    Not Confirmed
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    ASTRAZENECA AB

    United Kingdom
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    American Pharma Summit
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

    Brand Name : QTERN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG;EQ 5MG BASE

    Approval Date : 2019-05-02

    Application Number : 209091

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    10

    ASTRAZENECA AB

    United Kingdom
    American Pharma Summit
    Not Confirmed
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    ASTRAZENECA AB

    United Kingdom
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    American Pharma Summit
    Not Confirmed
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    RLD : Yes

    TE Code :

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

    Brand Name : QTERNMET XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 2.5MG;1GM;EQ 2.5MG BASE

    Approval Date : 2019-05-02

    Application Number : 210874

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    blank

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