Composition
- Active ingredients
- BOSUTINIB MONOHYDRATE EQ 100MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BOSUTINIB MONOHYDRATE EQ 100MG BASE · TabletANDA209624-002 · Tentative approval
- BOSUTINIB MONOHYDRATE EQ 500MG BASE · TabletANDA209624-003 · Tentative approval
- BOSUTINIB MONOHYDRATE 400MG · TabletANDA209624-001 · Tentative approval
- BOSUTINIB MONOHYDRATE EQ 100MG BASE · TabletThis page
- BOSUTINIB MONOHYDRATE EQ 500MG BASE · TabletANDA209577-003 · Tentative approval
- BOSUTINIB MONOHYDRATE 400MG · TabletANDA209577-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209577.
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
- Bosutinib
- Active substance
- bosutinib monohydrate
- Route
- Film coated
- Dosage form
- Tablet
- Applicant
- Sun Pharm Industries
- Status
- Tentative approval
- FDA approval
- 25 Aug 2023
- Application
- ANDA209577-002