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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 091055


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NDA 091055 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, Pharmobedient, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 091055
Tradename:EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:Strides Pharma
Ingredient:emtricitabine; tenofovir disoproxil fumarate
Patents:0
Pharmacology for NDA: 091055
Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 091055
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091055 ANDA Strides Pharma Inc. 42543-719 42543-719-04 30 TABLET in 1 BOTTLE, PLASTIC (42543-719-04)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091055 ANDA Golden State Medical Supply, Inc. 51407-112 51407-112-30 30 TABLET in 1 BOTTLE, PLASTIC (51407-112-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Jan 13, 2021TE:ABRLD:No

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Preferred Citation:

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