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01 2ENDO OPERATIONS

02 4Future Health Pharma GmbH

03 7Noden Pharma

04 11Novartis Pharmaceuticals Corporation

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PharmaCompass

01

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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02

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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03

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Dosage Strength : EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-01-18

Application Number : 22107

Regulatory Info : DISCN

Registration Country : USA

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04

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Dosage Strength : EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-01-18

Application Number : 22107

Regulatory Info : DISCN

Registration Country : USA

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05

American Pharma Summit
Not Confirmed
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American Pharma Summit
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**

Packaging :

Approval Date : 2008-01-18

Application Number : 22107

Regulatory Info : DISCN

Registration Country : USA

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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
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**

Packaging :

Approval Date : 2008-01-18

Application Number : 22107

Regulatory Info : DISCN

Registration Country : USA

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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ALISKIREN HEMIFUMARATE

Brand Name : TEKTURNA

Dosage Form : CAPSULE, PELLET;ORAL

Dosage Strength : EQ 37.5MG BASE

Packaging :

Approval Date : 2017-11-14

Application Number : 210709

Regulatory Info : DISCN

Registration Country : USA

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08

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ALISKIREN HEMIFUMARATE; VALSARTAN

Brand Name : VALTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;160MG

Packaging :

Approval Date : 2009-09-16

Application Number : 22217

Regulatory Info : DISCN

Registration Country : USA

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09

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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10

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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11

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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12

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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13

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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14

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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15

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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16

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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17

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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18

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

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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19

ENDO OPERATIONS

Country
American Pharma Summit
Not Confirmed
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ENDO OPERATIONS

Country
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American Pharma Summit
Not Confirmed

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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20

ENDO OPERATIONS

Country
American Pharma Summit
Not Confirmed
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ENDO OPERATIONS

Country
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American Pharma Summit
Not Confirmed

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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