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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 021985


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NDA 021985 describes TEKTURNA, which is a drug marketed by Noden Pharma and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TEKTURNA profile page.

The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for 021985
Tradename:TEKTURNA
Applicant:Noden Pharma
Ingredient:aliskiren hemifumarate
Patents:1
Pharmacology for NDA: 021985
Mechanism of ActionRenin Inhibitors
Suppliers and Packaging for NDA: 021985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985 NDA A-S Medication Solutions 50090-2985 50090-2985-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-2985-0)
TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-141 66993-141-30 30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 5, 2007TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 19, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Mar 5, 2007TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 19, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021985

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 ⤷  Sign Up ⤷  Sign Up
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.