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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 two NDAs. It is available from three suppliers. There are three 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. Two suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

Summary for NDA: 021985

Tradename:
TEKTURNA
Applicant:
Noden Pharma
Ingredient:
aliskiren hemifumarate
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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 Novartis Pharmaceuticals Corporation 0078-0485 0078-0485-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0485-15)
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL 021985 NDA Novartis Pharmaceuticals Corporation 0078-0485 0078-0485-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0485-34)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 5, 2007TE:RLD:No
Patent:8,617,595Patent Expiration:Feb 19, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:5,559,111Patent Expiration:Jul 21, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERTENSION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Mar 5, 2007TE:RLD:Yes
Patent:8,617,595Patent Expiration:Feb 19, 2026Product Flag?YSubstance Flag?Delist Request?


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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 verifification 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.

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