01 2ENDO OPERATIONS
02 4Future Health Pharma GmbH
03 7Noden Pharma
04 11Novartis Pharmaceuticals Corporation
01 1CAPSULE, PELLET;ORAL
02 4Filmtabl
03 19TABLET;ORAL
01 16DISCN
02 4RX
03 4Blank
01 2ALISKIREN HEMIFUMARATE
02 5AMTURNIDE
03 4Rasilez
04 4TEKAMLO
05 3TEKTURNA
06 4TEKTURNA HCT
07 2VALTURNA
01 4Switzerland
02 20USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
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
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
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
Regulatory Info : DISCN
Registration Country : USA
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
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rasilez
Dosage Form : Filmtabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rasilez
Dosage Form : Filmtabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rasilez
Dosage Form : Filmtabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rasilez
Dosage Form : Filmtabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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