emtricitabine

FDA Drug Profile — emtricitabine

Drug Details

Generic Name
emtricitabine
Brand Names
emtricitabine
Application Number
ANDA091168
Sponsor
Macleods Pharmaceuticals Limited
NDC Codes
3
Dosage Forms
POWDER, CAPSULE
Routes
ORAL
Active Ingredients
EMTRICITABINE

Indications and Usage

1 INDICATIONS AND USAGE Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet 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. 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 )