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01 2ENDO OPERATIONS

02 7NODEN PHARMA

03 11NOVARTIS

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PharmaCompass

01

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ALISKIREN HEMIFUMARATE

Brand Name : TEKTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2007-03-05

Application Number : 21985

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

ALISKIREN HEMIFUMARATE

Brand Name : TEKTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2007-03-05

Application Number : 21985

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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Dosage Strength : EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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Dosage Strength : EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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Dosage Strength : EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

ALISKIREN HEMIFUMARATE; VALSARTAN

Brand Name : VALTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;160MG

Approval Date : 2009-09-16

Application Number : 22217

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

ALISKIREN HEMIFUMARATE; VALSARTAN

Brand Name : VALTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE;320MG

Approval Date : 2009-09-16

Application Number : 22217

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Brand Name : TEKAMLO

Dosage Form : TABLET;ORAL

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

Approval Date : 2010-08-26

Application Number : 22545

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Brand Name : TEKAMLO

Dosage Form : TABLET;ORAL

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

Approval Date : 2010-08-26

Application Number : 22545

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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