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General MedicationsORALStandard

XROMI

HYDROXYUREA

Standard Dose
100MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview XROMI is listed in Drugs@FDA under application 216593 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient HYDROXYUREA Form and strength SOLUTION;ORAL - 100MG/ML Sponsor NOVA LABS LTD Submission history Latest submission status date: 2024-12-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview XROMI is listed in Drugs@FDA under application 216593 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient HYDROXYUREA Form and strength SOLUTION;ORAL - 100MG/ML Sponsor NOVA LABS LTD Submission history Latest submission status date: 2024-12-23 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.