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General MedicationsORALStandard

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Standard Dose
600MG;200MG;300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 213541 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 600MG;200MG;300MG Sponsor LAURUS Submission history Latest submission status date: 2021-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 213541 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 600MG;200MG;300MG Sponsor LAURUS Submission history Latest submission status date: 2021-12-22 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.