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General MedicationsORALGeneric

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

Standard Dose
60MG;5MG;30MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: None (Tentative Approval)
Summary

Approval overview ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE is listed in Drugs@FDA under application 217070 (NDA).

Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE Form and strength TABLET; ORAL - 60MG;5MG;30MG Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2023-08-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE is listed in Drugs@FDA under application 217070 (NDA). Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE Form and strength TABLET; ORAL - 60MG;5MG;30MG Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2023-08-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.