General MedicationsORALStandard
XURIDEN
URIDINE TRIACETATE
Standard Dose
2GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview XURIDEN is listed in Drugs@FDA under application 208169 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient URIDINE TRIACETATE Form and strength GRANULE;ORAL - 2GM/PACKET Sponsor BTG INTL Submission history Latest submission status date: 2019-12-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview XURIDEN is listed in Drugs@FDA under application 208169 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient URIDINE TRIACETATE Form and strength GRANULE;ORAL - 2GM/PACKET Sponsor BTG INTL Submission history Latest submission status date: 2019-12-02 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.