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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 214095

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NDA 214095 describes EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE, which is a drug marketed by Apotex and is included in one NDA. Additional details are available on the EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE profile page.

The generic ingredient in EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE 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 214095

Tradename:	EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
Applicant:	Apotex
Ingredient:	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE;EQ 25MG BASE
Approval Date:	Jan 30, 2026	TE:	AB	RLD:	No

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