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General MedicationsORALStandard

DUVYZAT

GIVINOSTAT HYDROCHLORIDE

Standard Dose
EQ 8.86MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview DUVYZAT is listed in Drugs@FDA under application 217865 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient GIVINOSTAT HYDROCHLORIDE Form and strength SUSPENSION;ORAL - EQ 8.86MG BASE/ML Sponsor ITALFARMACO SPA Submission history Latest submission status date: 2024-03-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview DUVYZAT is listed in Drugs@FDA under application 217865 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient GIVINOSTAT HYDROCHLORIDE Form and strength SUSPENSION;ORAL - EQ 8.86MG BASE/ML Sponsor ITALFARMACO SPA Submission history Latest submission status date: 2024-03-21 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.