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General MedicationsORALStandard

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Standard Dose
167MG;250MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 212689 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 167MG;250MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2024-12-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 212689 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 167MG;250MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2024-12-04 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.