Composition
- Active ingredients
- BINIMETINIB 15MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BINIMETINIB 15MG · TabletANDA217678-001 · Tentative approval
- BINIMETINIB 15MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA217509.
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
- Binimetinib
- Dosage form
- Tablet
- Applicant
- Teva Pharmaceuticals USA, Inc.
- Status
- Tentative approval
- FDA approval
- 10 Dec 2024
- Application
- ANDA217509-001