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General MedicationsORALGeneric

DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE

DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE

Standard Dose
50MG;200MG;25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 214544 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE Form and strength TABLET;ORAL - 50MG;200MG;25MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-01-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 214544 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE Form and strength TABLET;ORAL - 50MG;200MG;25MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-01-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.