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General MedicationsINTRAVENOUSGeneric

AVGEMSI

GEMCITABINE HYDROCHLORIDE

Standard Dose
EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Discontinued
Summary

Approval overview AVGEMSI is listed in Drugs@FDA under application 219920 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-06-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview AVGEMSI is listed in Drugs@FDA under application 219920 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.