| attribute | value |
|---|---|
| Drug Name | XARELTO |
| Application Number | 202439 |
| Active Ingredient(s) | RIVAROXABAN |
| Company | JANSSEN PHARMS |
| Drug Name | Active Ingredient(s) | Strength | Form/Route | Marketing Status | RLD | TE Code |
|---|---|---|---|---|---|---|
| XARELTO | RIVAROXABAN | 15MG | TABLET; ORAL | 1 | 0 | |
| XARELTO | RIVAROXABAN | 20MG | TABLET; ORAL | 1 | 1 | |
| XARELTO | RIVAROXABAN | 20MG | TABLET; ORAL | 1 | 2 | TBD |
| Date | Supplement No. | Action | Documents |
|---|---|---|---|
| Nov 05, 2012 | 007 | Labeling Revision | |
| Jul 12, 2012 | 005 | Labeling Revision | |
| Nov 04, 2011 | 000 | Approval | |
| Dec 05, 2011 | 001 | Labeling Revision | |
| Apr 03, 2013 | 003 | Manufacturing Change or Addition |