efavirenz, emtricitabine and tenofovir disoproxil fumarate

FDA Drug Profile — efavirenz, emtricitabine and tenofovir disoproxil fumarate

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 tablets are 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 )