Composition
- Active ingredients
- NINTEDANIB 100MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- NINTEDANIB 100MG · CapsuleANDA218472-002 · Tentative approval
- NINTEDANIB 25MG · CapsuleANDA218472-003 · Tentative approval
- NINTEDANIB 100MG · CapsuleThis page
- NINTEDANIB 100MG · CapsuleANDA219371-002 · Tentative approval
- NINTEDANIB 25MG · CapsuleANDA219371-003 · Tentative approval
- NINTEDANIB EQ 150MG BASE · CapsuleANDA212732-002 · Tentative approval
- NINTEDANIB EQ 100MG BASE · CapsuleANDA212732-001 · Tentative approval
- NINTEDANIB EQ 150MG BASE · CapsuleANDA215123-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219708.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Nintedanib
- Dosage form
- Capsule
- Applicant
- Qilu Pharmaceutical Co., LTD.
- Status
- Tentative approval
- FDA approval
- 17 Mar 2026
- Application
- ANDA219708-002