Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINTRAVENOUSStandard

AVGEMSI

GEMCITABINE HYDROCHLORIDE

Standard Dose
EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

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

Review priority: PRIORITY Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 1GM BASE/26.3ML (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: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 1GM BASE/26.3ML (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: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.