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General MedicationsORALGeneric

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE

Standard Dose
300MG; 300MG; 200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE is listed in Drugs@FDA under application 205355 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE Form and strength TABLET; ORAL - 300MG; 300MG; 200MG Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2014-03-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE is listed in Drugs@FDA under application 205355 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE Form and strength TABLET; ORAL - 300MG; 300MG; 200MG Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2014-03-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.