Application 210745
- Type
- NDA
- Sponsor
- AMGEN INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OTEZLA XR | APREMILAST | TABLET, EXTENDED RELEASE;ORAL | 75MG | Yes | Yes |
| 002 | OTEZLA | APREMILAST | TABLET;ORAL | 10MG | No | No |
| 003 | OTEZLA | APREMILAST | TABLET;ORAL | 20MG | No | No |
| 005 | OTEZLA | APREMILAST | TABLET;ORAL | 30MG | No | No |