Last Updated: June 24, 2026

Details for New Drug Application (NDA): 204869

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NDA 204869 describes EFAVIRENZ, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Pharmobedient, Strides Pharma, Hetero Labs Ltd V, Laurus, Teva Pharms Usa, and Chartwell Rx, and is included in twenty-one NDAs. It is available from five suppliers. Additional details are available on the EFAVIRENZ profile page.

The generic ingredient in EFAVIRENZ 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 204869

Tradename:	EFAVIRENZ
Applicant:	Pharmobedient
Ingredient:	efavirenz
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Mar 12, 2018	TE:	AB	RLD:	No

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