General MedicationsCAPSULEGeneric
NILOTINIB
NILOTINIB
Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview NILOTINIB is listed in Drugs@FDA under application 218532 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NILOTINIB Form and strength CAPSULE - 200MG Sponsor TORRENT Submission history Latest submission status date: 2025-12-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview NILOTINIB is listed in Drugs@FDA under application 218532 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NILOTINIB Form and strength CAPSULE - 200MG Sponsor TORRENT Submission history Latest submission status date: 2025-12-15 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.