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General MedicationsORALStandard

NITYR

NITISINONE

Standard Dose
5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview NITYR is listed in Drugs@FDA under application 209449 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient NITISINONE Form and strength TABLET;ORAL - 5MG Sponsor CYCLE Submission history Latest submission status date: 2025-06-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview NITYR is listed in Drugs@FDA under application 209449 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient NITISINONE Form and strength TABLET;ORAL - 5MG Sponsor CYCLE Submission history Latest submission status date: 2025-06-10 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.