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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 200045

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NDA 200045 describes AMTURNIDE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the AMTURNIDE profile page.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

Summary for 200045

Tradename:	AMTURNIDE
Applicant:	Novartis
Ingredient:	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE;EQ 5MG BASE;12.5MG
Approval Date:	Dec 21, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE;EQ 5MG BASE;12.5MG
Approval Date:	Dec 21, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE;EQ 5MG BASE;25MG
Approval Date:	Dec 21, 2010	TE:		RLD:	No

Expired US Patents for NDA 200045

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	8,618,174	⤷ Start Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010	5,559,111	⤷ Start Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	5,559,111	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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