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General MedicationsORALGeneric

EPIVIR-HBV

LAMIVUDINE

Standard Dose
5MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview EPIVIR-HBV is listed in Drugs@FDA under application 021004 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LAMIVUDINE Form and strength SOLUTION;ORAL - 5MG/ML Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2021-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview EPIVIR-HBV is listed in Drugs@FDA under application 021004 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LAMIVUDINE Form and strength SOLUTION;ORAL - 5MG/ML Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2021-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.