Application 208544
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54786 | ORIG | 2018-07-06 |