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Last Updated: November 22, 2024

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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;EQ 5MG BASE;12.5MG
Approval Date:Dec 21, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE;EQ 5MG BASE;12.5MG
Approval Date:Dec 21, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE;EQ 5MG BASE;25MG
Approval Date:Dec 21, 2010TE:RLD:No

Expired US Patents for NDA 200045

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-001 Dec 21, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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