Application 208236
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
| 002 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 250MCG | No | No |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
| 002 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 250MCG | No | No |