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General MedicationsORALGeneric

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

Approval overview EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 091593 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET; ORAL - 200MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2017-09-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 091593 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET; ORAL - 200MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2017-09-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.