Details for New Drug Application (NDA): 203053

NDA 203053 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 seven 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.

Summary for 203053

Tradename:	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Hetero Labs Ltd V
Ingredient:	efavirenz; emtricitabine; tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 203053

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: 203053

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	203053	ANDA	Camber Pharmaceuticals, Inc.	31722-736	31722-736-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-736-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG;200MG;300MG
Approval Date:	Jan 24, 2022	TE:	AB	RLD:	No

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