efavirenz, emtricitabine and tenofovir disoproxil fumarate

FDA Drug Profile — efavirenz, emtricitabine and tenofovir disoproxil fumarate

efavirenz, emtricitabine and tenofovir disoproxil fumarate is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including efavirenz, emtricitabine and tenofovir disoproxil fumarate. Available dosage form: tablet, film coated.

Drug Details

Generic Name
efavirenz, emtricitabine and tenofovir disoproxil fumarate
Brand Names
efavirenz, emtricitabine and tenofovir disoproxil fumarate
Application Number
ANDA206894
Sponsor
Cipla USA Inc.
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. (1)