Details for New Drug Application (NDA): 078064

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NDA 078064 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.

Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFAVIRENZ	efavirenz	CAPSULE;ORAL	078064	ANDA	Aurobindo Pharma Limited	65862-104	65862-104-10	3 BLISTER PACK in 1 CARTON (65862-104-10) / 10 CAPSULE in 1 BLISTER PACK
EFAVIRENZ	efavirenz	CAPSULE;ORAL	078064	ANDA	Aurobindo Pharma Limited	65862-104	65862-104-30	30 CAPSULE in 1 BOTTLE (65862-104-30)

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 15, 2017	TE:		RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 15, 2017	TE:		RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Dec 15, 2017	TE:		RLD:	No

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