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Last Updated: April 4, 2026

Details for New Drug Application (NDA): 079188


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NDA 079188 describes EMTRICITABINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Apotex, Lupin Ltd, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Pharmobedient, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Mylan, and is included in nineteen NDAs. It is available from two suppliers. Additional details are available on the EMTRICITABINE profile page.

The generic ingredient in EMTRICITABINE is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.
Summary for 079188
Tradename:EMTRICITABINE
Applicant:Aurobindo Pharma Ltd
Ingredient:emtricitabine
Patents:0
Pharmacology for NDA: 079188
Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors
Medical Subject Heading (MeSH) Categories for 079188
Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 079188
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE emtricitabine CAPSULE;ORAL 079188 ANDA Aurobindo Pharma Limited 65862-301 65862-301-05 500 CAPSULE in 1 BOTTLE (65862-301-05)
EMTRICITABINE emtricitabine CAPSULE;ORAL 079188 ANDA Aurobindo Pharma Limited 65862-301 65862-301-30 30 CAPSULE in 1 BOTTLE (65862-301-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 15, 2023TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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