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Details for New Drug Application (NDA): 022545

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NDA 022545 describes TEKAMLO, which is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TEKAMLO profile page.

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

Summary for NDA: 022545

aliskiren hemifumarate; amlodipine besylate
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;EQ 5MG BASE
Approval Date:Aug 26, 2010TE:RLD:No
Patent:8,613,949Patent Expiration:Dec 21, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:5,559,111Patent Expiration:Jul 21, 2018Product Flag?YSubstance Flag?YDelist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;EQ 10MG BASE
Approval Date:Aug 26, 2010TE:RLD:No
Patent:8,613,949Patent Expiration:Dec 21, 2029Product 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.