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General MedicationsINTRAVESICALStandard

INLEXZO

GEMCITABINE HYDROCHLORIDE

Standard Dose
EQ 225MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview INLEXZO is listed in Drugs@FDA under application 219683 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SYSTEM;INTRAVESICAL - EQ 225MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-09-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview INLEXZO is listed in Drugs@FDA under application 219683 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SYSTEM;INTRAVESICAL - EQ 225MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-09-09 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.