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General MedicationsORALStandard

SYMTUZA

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Standard Dose
150MG;800MG;200MG;EQ 10MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SYMTUZA is listed in Drugs@FDA under application 210455 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Form and strength TABLET;ORAL - 150MG;800MG;200MG;EQ 10MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2023-03-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview SYMTUZA is listed in Drugs@FDA under application 210455 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Form and strength TABLET;ORAL - 150MG;800MG;200MG;EQ 10MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2023-03-31 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.