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General MedicationsORALGeneric

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Standard Dose
400MG; 200MG; 25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 213509 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Form and strength TABLET; ORAL - 400MG; 200MG; 25MG Sponsor MYLAN Submission history Latest submission status date: 2024-03-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 213509 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Form and strength TABLET; ORAL - 400MG; 200MG; 25MG Sponsor MYLAN Submission history Latest submission status date: 2024-03-22 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.