Composition
- Active ingredients
- APREMILAST 75MG
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA210745.
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
- Otezla XR
- Active substance
- apremilast
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Amgen Inc
- Status
- Prescription
- FDA approval
- 29 Aug 2025
- Application
- NDA210745-001