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General MedicationsORALStandard

VISTOGARD

URIDINE TRIACETATE

Standard Dose
10GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview VISTOGARD is listed in Drugs@FDA under application 208159 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient URIDINE TRIACETATE Form and strength GRANULE;ORAL - 10GM/PACKET Sponsor BTG INTL Submission history Latest submission status date: 2016-06-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview VISTOGARD is listed in Drugs@FDA under application 208159 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient URIDINE TRIACETATE Form and strength GRANULE;ORAL - 10GM/PACKET Sponsor BTG INTL Submission history Latest submission status date: 2016-06-07 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.