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General MedicationsORALStandard

EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Standard Dose
200MG;EQ 25MG BASE;300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 208452 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 200MG;EQ 25MG BASE;300MG Sponsor MYLAN Submission history Latest submission status date: 2025-05-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 208452 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 200MG;EQ 25MG BASE;300MG Sponsor MYLAN Submission history Latest submission status date: 2025-05-20 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.