Composition
- Active ingredients
- UPADACITINIB 15MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- UPADACITINIB 30MG · Tablet, extended releaseANDA218792-002 · Tentative approval
- UPADACITINIB 15MG · Tablet, extended releaseThis page
- UPADACITINIB 30MG · TabletANDA218866-002 · Tentative approval
- UPADACITINIB 15MG · TabletANDA218866-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218792.
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
- Upadacitinib
- Dosage form
- Tablet, extended release
- Applicant
- Sandoz Inc
- Status
- Tentative approval
- FDA approval
- 14 Nov 2025
- Application
- ANDA218792-003