General MedicationsORALGeneric

LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS

LAMIVUDINE; TENOFOVIR

Standard Dose

300MG/300MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS is listed in Drugs@FDA under application 022459 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LAMIVUDINE; TENOFOVIR Form and strength TABLET; ORAL - 300MG/300MG Sponsor HETERO DRUGS LTD Submission history Latest submission status date: 2009-11-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS is listed in Drugs@FDA under application 022459 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient LAMIVUDINE; TENOFOVIR Form and strength TABLET; ORAL - 300MG/300MG Sponsor HETERO DRUGS LTD Submission history Latest submission status date: 2009-11-05 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.