Otezla
- Product NDC
- 55513-519
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apremilast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amgen, Inc
- Application
- NDA205437
- Marketing category
- NDA
- Substance
- APREMILAST
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 55513-519-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55513-519-30) | 2025-08-31 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Otezla | Amgen, Inc | Celgene International Sarl | 2025-12-23 | HUMAN PRESCRIPTION DRUG LABEL | 34 |