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General MedicationsORALStandard

NITISINONE

NITISINONE

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

Approval overview NITISINONE is listed in Drugs@FDA under application 216201 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NITISINONE Form and strength CAPSULE;ORAL - 5MG Sponsor ETON Submission history Latest submission status date: 2023-05-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview NITISINONE is listed in Drugs@FDA under application 216201 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NITISINONE Form and strength CAPSULE;ORAL - 5MG Sponsor ETON Submission history Latest submission status date: 2023-05-25 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.