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Last Updated: April 4, 2026

Details for New Drug Application (NDA): 091168


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NDA 091168 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 091168
Tradename:EMTRICITABINE
Applicant:Cipla
Ingredient:emtricitabine
Patents:0
Pharmacology for NDA: 091168
Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors
Medical Subject Heading (MeSH) Categories for 091168
Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 091168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE emtricitabine CAPSULE;ORAL 091168 ANDA Cipla USA Inc. 69097-642 69097-642-02 30 CAPSULE in 1 BOTTLE (69097-642-02)
EMTRICITABINE emtricitabine CAPSULE;ORAL 091168 ANDA Cipla USA Inc. 69097-642 69097-642-15 1000 CAPSULE in 1 BOTTLE (69097-642-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2018TE:ABRLD:No

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Preferred Citation:

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