Product manufactured by Janssen Products Lp

Application Nr Approved Date Route Status External Links
NDA021976 2012-11-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Prezista®, Co-Administered With Ritonavir (prezista/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)]. Prezista 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. Prezista Must Be Co-Administered With Ritonavir (prezista/ritonavir) And With Other Antiretroviral Agents. (1)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Methylparaben Sodium METHYLPARABEN SODIUM Molecular
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Water WATER Molecular
5. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Darunavir Ethanolate DARUNAVIR ETHANOLATE ZINC3955219