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General MedicationsORALStandard

BIKTARVY

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Standard Dose
EQ 30MG BASE;120MG;EQ 15MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BIKTARVY is listed in Drugs@FDA under application 210251 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Form and strength TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2025-07-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview BIKTARVY is listed in Drugs@FDA under application 210251 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Form and strength TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2025-07-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.