Details for New Drug Application (NDA): 213038

NDA 213038 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 213038

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

Pharmacology for NDA: 213038

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

Suppliers and Packaging for NDA: 213038

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	213038	ANDA	Laurus Labs Limited	42385-929	42385-929-18	180 TABLET, FILM COATED in 1 BOTTLE (42385-929-18)
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	213038	ANDA	Laurus Labs Limited	42385-929	42385-929-30	30 TABLET, FILM COATED in 1 BOTTLE (42385-929-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG;300MG;300MG
Approval Date:	May 14, 2020	TE:	AB	RLD:	No

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