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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 205322

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NDA 205322 describes EFAVIRENZ, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Strides Pharma, Hetero Labs Ltd V, Laurus, and Teva Pharms Usa, and is included in twenty-one NDAs. It is available from eight 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 205322

Tradename:	EFAVIRENZ
Applicant:	Aurobindo Pharma
Ingredient:	efavirenz
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Aug 30, 2018	TE:		RLD:	No

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