Composition
- Active ingredients
- NILOTINIB HYDROCHLORIDE DIHYDRATE 150MG
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209651.
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
- Nilotinib Hydrochloride Dihydrate
- Dosage form
- Capsule
- Applicant
- Hetero Labs LTD V
- Status
- Tentative approval
- FDA approval
- 19 Nov 2025
- Application
- ANDA209651-003