Composition
- Active ingredients
- Ruxolitinib 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- Ruxolitinib 15MG · TabletNDA219660-003 · Tentative approval
- Ruxolitinib 2MG · TabletNDA219660-004 · Tentative approval
- Ruxolitinib 10MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA219660.
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
- Ruxolitinib
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Apotex
- Status
- Tentative approval
- FDA approval
- 21 Nov 2025
- Application
- NDA219660-002