darunavir
Drug Details
- Generic Name
- darunavir
- Brand Names
- Darunavir 600 and 800 mg, PREZISTA
- Application Number
- ANDA206288
- Sponsor
- Cipla USA Inc.
- NDC Codes
- 8
- Dosage Forms
- TABLET, TABLET, FILM COATED, SUSPENSION
- Routes
- ORAL
- Active Ingredients
- DARUNAVIR HYDRATE, DARUNAVIR ETHANOLATE, DARUNAVIR DIHYDRATE
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 )