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General MedicationsCAPSULEGeneric

NILOTINIB HYDROCHLORIDE DIHYDRATE

NILOTINIB HYDROCHLORIDE DIHYDRATE

Standard Dose
150MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview NILOTINIB HYDROCHLORIDE DIHYDRATE is listed in Drugs@FDA under application 209651 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NILOTINIB HYDROCHLORIDE DIHYDRATE Form and strength CAPSULE - 150MG Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-11-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview NILOTINIB HYDROCHLORIDE DIHYDRATE is listed in Drugs@FDA under application 209651 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NILOTINIB HYDROCHLORIDE DIHYDRATE Form and strength CAPSULE - 150MG Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2025-11-19 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.