Details for New Drug Application (NDA): 213541

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NDA 213541 describes EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, and Teva Pharms Usa, and is included in six NDAs. It is available from six suppliers. Additional details are available on the EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE profile page.

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

Tradename:	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Laurus
Ingredient:	efavirenz; emtricitabine; tenofovir disoproxil fumarate
Patents:	0

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 Nucleoside Reverse Transcriptase Inhibitors

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	213541	ANDA	Laurus Labs Limited	42385-915	42385-915-30	30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30)
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	213541	ANDA	Laurus Labs Limited	42385-915	42385-915-90	90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG;200MG;300MG
Approval Date:	Dec 22, 2021	TE:	AB	RLD:	No

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