Last Updated: May 5, 2026

Details for New Drug Application (NDA): 214216

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NDA 214216 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 214216

Tradename:	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
Applicant:	Macleods Pharms 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:	Apr 7, 2026	TE:	AB	RLD:	No

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