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General MedicationsORALGeneric

DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Standard Dose
50MG; 300MG; 300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 213556 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 50MG; 300MG; 300MG Sponsor SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD Submission history Latest submission status date: 2020-10-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE is listed in Drugs@FDA under application 213556 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Form and strength TABLET;ORAL - 50MG; 300MG; 300MG Sponsor SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD Submission history Latest submission status date: 2020-10-06 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.