Application 215859
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XARELTO | RIVAROXABAN | SUSPENSION;ORAL | 1MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50458-575 | Xarelto | rivaroxaban | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-575 | Xarelto | rivaroxaban | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-575 | Xarelto | rivaroxaban | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-575 | Xarelto | rivaroxaban | Janssen Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85554 | SUPPL | 2026-03-27 |
| 85535 | SUPPL | 2026-03-27 |
| 85540 | SUPPL | 2026-03-24 |
| 82603 | SUPPL | 2025-06-20 |
| 82600 | SUPPL | 2025-06-20 |
| 82598 | SUPPL | 2025-06-18 |
| 73506 | SUPPL | 2023-02-15 |
| 73424 | SUPPL | 2023-02-09 |
| 71009 | ORIG | 2022-05-06 |
| 69738 | ORIG | 2021-12-22 |
| 69696 | ORIG | 2021-12-20 |
| 69695 | ORIG | 2021-12-20 |