General MedicationsCAPSULEGeneric
NINTEDANIB
NINTEDANIB
Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview NINTEDANIB is listed in Drugs@FDA under application 219708 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NINTEDANIB Form and strength CAPSULE - 100MG Sponsor QILU PHARMACEUTICAL CO., LTD.
Structured Monograph
Clinical summary
Approval overview NINTEDANIB is listed in Drugs@FDA under application 219708 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NINTEDANIB Form and strength CAPSULE - 100MG Sponsor QILU PHARMACEUTICAL CO., LTD. Submission history Latest submission status date: 2026-03-17 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.