Last Updated: May 5, 2026

Details for New Drug Application (NDA): 214053

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NDA 214053 describes EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, which is a drug marketed by Apotex, Lupin Ltd, and Macleods Pharms Ltd, and is included in three 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 214053

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	120MG;EQ 15MG BASE
Approval Date:	May 17, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE
Approval Date:	May 17, 2024	TE:		RLD:	No

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