Application 213064
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EDOXABAN | EDOXABAN | TABLET;ORAL | 15MG | No | No |
| 002 | EDOXABAN | EDOXABAN | TABLET;ORAL | 30MG | No | No |
| 003 | EDOXABAN | EDOXABAN | TABLET;ORAL | 60MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72947 | ORIG | 2022-12-20 |