Application 206088
- Type
- NDA
- Sponsor
- CELGENE CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OTEZLA | APREMILAST | TABLET;ORAL | 10MG | Yes | No |
| 002 | OTEZLA | APREMILAST | TABLET;ORAL | 20MG | Yes | No |
| 003 | OTEZLA | APREMILAST | TABLET;ORAL | 30MG | Yes | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Otezla | APREMILAST | Amgen, Inc | f6b1f516-4972-4d82-bced-113e47b41cc5 | 2025-12-23 | Warnings, Adverse reactions | Otezla APREMILAST |