Application 218445
- Type
- ANDA
- Sponsor
- REGCON HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 2.5MG | No | No |
| 002 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 10MG | No | No |
| 003 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 15MG | No | No |
| 004 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 20MG | No | No |