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General MedicationsORALGeneric

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE

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

Approval overview ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE is listed in Drugs@FDA under application 218383 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE Form and strength TABLET;ORAL - 5MG Sponsor LUPIN LTD Submission history Latest submission status date: 2024-12-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE is listed in Drugs@FDA under application 218383 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE Form and strength TABLET;ORAL - 5MG Sponsor LUPIN LTD Submission history Latest submission status date: 2024-12-03 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.