General MedicationsORALStandard
PREZCOBIX
COBICISTAT; DARUNAVIR ETHANOLATE
Standard Dose
150MG;EQ 800MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PREZCOBIX is listed in Drugs@FDA under application 205395 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR ETHANOLATE Form and strength TABLET;ORAL - 150MG;EQ 800MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2026-02-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview PREZCOBIX is listed in Drugs@FDA under application 205395 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR ETHANOLATE Form and strength TABLET;ORAL - 150MG;EQ 800MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2026-02-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.