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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213926

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NDA 213926 describes EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, which is a drug marketed by Apotex and Lupin Ltd and is included in two NDAs. Additional details are available on the EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE profile page.

The generic ingredient in EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE is emtricitabine; 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; tenofovir alafenamide fumarate profile page.

Summary for 213926

Tradename:	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
Applicant:	Lupin Ltd
Ingredient:	emtricitabine; tenofovir alafenamide fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE
Approval Date:	Dec 13, 2024	TE:	AB	RLD:	No

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