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General MedicationsORALGeneric

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

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; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE is listed in Drugs@FDA under application 217016 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE Form and strength TABLET; ORAL - 50MG/300MG/300MG Sponsor STRIDES PHARMA Submission history Latest submission status date: 2023-09-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE is listed in Drugs@FDA under application 217016 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE Form and strength TABLET; ORAL - 50MG/300MG/300MG Sponsor STRIDES PHARMA Submission history Latest submission status date: 2023-09-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.