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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209061


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NDA 209061 describes EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Mylan and is included in one NDA. Additional details are available on the EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 209061
Tradename:EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant:Mylan
Ingredient:efavirenz; emtricitabine; tenofovir disoproxil fumarate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength600MG;200MG;300MG
Approval Date:Sep 5, 2024TE:RLD:No

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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