← FDA Drug Approvals (Drugs@FDA)
OTEZLA
NDA · New Drug Application · Sponsor: AMGEN INC · Approved 2025-08-29
Drug application
- FDA Application #
NDA210745- Application type
- New Drug Application
- Brand name
- OTEZLA
- Generic name
- Apremilast
- Active ingredients
- APREMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMGEN INC
- First approval
- 2025-08-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown