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General MedicationsORALStandard

NILOTINIB HYDROCHLORIDE

NILOTINIB HYDROCHLORIDE

Standard Dose
EQ 50MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NILOTINIB HYDROCHLORIDE is listed in Drugs@FDA under application 218544 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NILOTINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 50MG BASE Sponsor MSN Submission history Latest submission status date: 2025-11-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview NILOTINIB HYDROCHLORIDE is listed in Drugs@FDA under application 218544 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NILOTINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 50MG BASE Sponsor MSN Submission history Latest submission status date: 2025-11-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.