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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 210649

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NDA 210649 describes EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma Ltd, Laurus, and Macleods Pharms Ltd, and is included in four NDAs. It is available from one supplier. Additional details are available on the EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.

Summary for 210649

Tradename:	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Macleods Pharms Ltd
Ingredient:	efavirenz; lamivudine; tenofovir disoproxil fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;300MG;300MG
Approval Date:	Mar 15, 2019	TE:		RLD:	No

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