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Details for New Drug Application (NDA): 022107

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NDA 022107 describes TEKTURNA HCT, which is a drug marketed by Noden Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEKTURNA HCT profile page.

The generic ingredient in TEKTURNA HCT 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: 022107

Tradename:
TEKTURNA HCT
Applicant:
Noden Pharma
Ingredient:
aliskiren hemifumarate; hydrochlorothiazide
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 022107

Ingredient-typeThiazides
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 022107

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL 022107 NDA Novartis Pharmaceuticals Corporation 0078-0521 0078-0521-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0521-15)
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL 022107 NDA Novartis Pharmaceuticals Corporation 0078-0521 0078-0521-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0521-34)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE;12.5MG
Approval Date:Jan 18, 2008TE:RLD:No
Patent:8,618,172Patent Expiration:Jul 13, 2028Product 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 150MG BASE;25MG
Approval Date:Jan 18, 2008TE:RLD:No
Patent:8,618,172Patent Expiration:Jul 13, 2028Product 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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