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    Aliskiren Hemifumarate

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    01

    LXO Group

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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

    Brand Name : TEKTURNA HCT

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2008-01-18

    Application Number : 22107

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    ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

    Brand Name : TEKTURNA HCT

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2008-01-18

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    ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

    Brand Name : TEKTURNA HCT

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2008-01-18

    Application Number : 22107

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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

    Brand Name : TEKTURNA HCT

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 2008-01-18

    Application Number : 22107

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    05

    LXO Group

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    ALISKIREN HEMIFUMARATE

    Brand Name : TEKTURNA

    Dosage Form : CAPSULE, PELLET;ORAL

    Dosage Strength : EQ 37.5MG BASE

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    Approval Date : 2017-11-14

    Application Number : 210709

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    06

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; VALSARTAN

    Brand Name : VALTURNA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;160MG

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    Approval Date : 2009-09-16

    Application Number : 22217

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    ALISKIREN HEMIFUMARATE; VALSARTAN

    Brand Name : VALTURNA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;320MG

    Packaging :

    Approval Date : 2009-09-16

    Application Number : 22217

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Brand Name : TEKAMLO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;EQ 5MG BASE

    Packaging :

    Approval Date : 2010-08-26

    Application Number : 22545

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Regulatory Info : DISCN

    Registration Country : USA

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Brand Name : TEKAMLO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;EQ 10MG BASE

    Packaging :

    Approval Date : 2010-08-26

    Application Number : 22545

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Brand Name : TEKAMLO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 5MG BASE

    Packaging :

    Approval Date : 2010-08-26

    Application Number : 22545

    Regulatory Info : DISCN

    Registration Country : USA

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    11

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Brand Name : TEKAMLO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 10MG BASE

    Packaging :

    Approval Date : 2010-08-26

    Application Number : 22545

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
    Not Confirmed
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    Switzerland
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    Regulatory Info : DISCN

    Registration Country : USA

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Brand Name : AMTURNIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE;EQ 5MG BASE;12.5MG

    Packaging :

    Approval Date : 2010-12-21

    Application Number : 200045

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Switzerland
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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Brand Name : AMTURNIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 5MG BASE;12.5MG

    Packaging :

    Approval Date : 2010-12-21

    Application Number : 200045

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Brand Name : AMTURNIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 5MG BASE;25MG

    Packaging :

    Approval Date : 2010-12-21

    Application Number : 200045

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info : DISCN

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    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Brand Name : AMTURNIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 10MG BASE;12.5MG

    Packaging :

    Approval Date : 2010-12-21

    Application Number : 200045

    Regulatory Info : DISCN

    Registration Country : USA

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    16

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Brand Name : AMTURNIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE;EQ 10MG BASE;25MG

    Packaging :

    Approval Date : 2010-12-21

    Application Number : 200045

    Regulatory Info : DISCN

    Registration Country : USA

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    17

    LXO IRELAND

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    Regulatory Info : RX

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    ALISKIREN HEMIFUMARATE

    Brand Name : TEKTURNA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE

    Packaging :

    Approval Date : 2007-03-05

    Application Number : 21985

    Regulatory Info : RX

    Registration Country : USA

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    LXO IRELAND

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    Regulatory Info : RX

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    ALISKIREN HEMIFUMARATE

    Brand Name : TEKTURNA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE

    Packaging :

    Approval Date : 2007-03-05

    Application Number : 21985

    Regulatory Info : RX

    Registration Country : USA

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    19

    PH HEALTH

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    PH HEALTH

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    ALISKIREN HEMIFUMARATE

    Brand Name : ALISKIREN HEMIFUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 150MG BASE

    Packaging :

    Approval Date : 2019-03-22

    Application Number : 206665

    Regulatory Info : RX

    Registration Country : USA

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    PH HEALTH

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    Regulatory Info : RX

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    ALISKIREN HEMIFUMARATE

    Brand Name : ALISKIREN HEMIFUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 300MG BASE

    Packaging :

    Approval Date : 2019-03-22

    Application Number : 206665

    Regulatory Info : RX

    Registration Country : USA

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