| BRAND NAME | APPLICATION | SPONSOR | STATUS |
|---|---|---|---|
| EDOXABAN | ANDA213064 | ZYDUS PHARMS USA INC | None (Tentative Approval) |
| PRODUCT NAME | HOLDER | STATUS | DATE | INDICATION |
|---|---|---|---|---|
| Roteas | Berlin-Chemie AG | Authorised | 19/04/2017 | Stroke;Venous Thromboembolism |
| Lixiana | Daiichi Sankyo Europe GmbH | Authorised | 19/06/2015 | Stroke;Venous Thromboembolism |