Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

FDA Drug Profile — Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate, SYMFI

Drug Details

Generic Name
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Brand Names
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate, SYMFI
Application Number
ANDA213038
Sponsor
Laurus Labs Limited
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
EFAVIRENZ, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. ( 1 )