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General MedicationsORALStandard

PREZCOBIX PED

COBICISTAT; DARUNAVIR ETHANOLATE

Standard Dose
90MG;EQ 600MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PREZCOBIX PED is listed in Drugs@FDA under application 220092 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR ETHANOLATE Form and strength TABLET, FOR SUSPENSION;ORAL - 90MG;EQ 600MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2026-02-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREZCOBIX PED is listed in Drugs@FDA under application 220092 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR ETHANOLATE Form and strength TABLET, FOR SUSPENSION;ORAL - 90MG;EQ 600MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2026-02-27 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
PREZCOBIX PED (COBICISTAT; DARUNAVIR ETHANOLATE) | Drug Monograph | MedicHelpline