Composition
- Active ingredients
- APREMILAST 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- APREMILAST 30MG · TabletNDA206088-003 · Prescription
- APREMILAST 10MG · TabletNDA206088-001 · Prescription
- APREMILAST 20MG · TabletNDA206088-002 · Prescription
- APREMILAST 30MG · TabletNDA210745-005 · Prescription
- APREMILAST 20MG · TabletNDA210745-003 · Prescription
- APREMILAST 10MG · TabletNDA210745-002 · Prescription
- APREMILAST 30MG · TabletNDA205437-003 · Prescription
- APREMILAST 10MG · TabletThis page
- APREMILAST 20MG · TabletNDA205437-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA205437.
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
- Active substance
- apremilast
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Amgen Inc
- Status
- Prescription
- FDA approval
- 21 Mar 2014
- Application
- NDA205437-001