General MedicationsORALStandard
NITYR
NITISINONE
Standard Dose
10MG
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 - 10MG 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 - 10MG 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.