darunavir 800 mg

FDA Drug Profile — darunavir

Drug Details

Generic Name
darunavir 800 mg
Brand Names
darunavir
Application Number
ANDA206288
Sponsor
EXELAN PHARMACEUTICALS INC.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
DARUNAVIR HYDRATE

Indications and Usage

1 INDICATIONS AND USAGE Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 )] . Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. ( 1 )