Application 021923
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEXAVAR | SORAFENIB TOSYLATE | TABLET;ORAL | EQ 200MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-488 | Nexavar | sorafenib | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75646 | SUPPL | 2023-10-03 |
| 75547 | SUPPL | 2023-09-25 |
| 67669 | SUPPL | 2021-06-03 |
| 67573 | SUPPL | 2021-05-24 |
| 63842 | SUPPL | 2020-07-10 |
| 63841 | SUPPL | 2020-07-10 |
| 63665 | SUPPL | 2020-06-23 |
| 63662 | SUPPL | 2020-06-23 |
| 62527 | SUPPL | 2020-04-10 |
| 62437 | SUPPL | 2020-04-03 |
| 56656 | SUPPL | 2018-12-07 |
| 56655 | SUPPL | 2018-12-07 |
| 56646 | SUPPL | 2018-12-07 |
| 56645 | SUPPL | 2018-12-07 |
| 50929 | SUPPL | 2017-12-27 |
| 50914 | SUPPL | 2017-12-27 |
| 6458 | SUPPL | 2013-11-25 |
| 37882 | SUPPL | 2013-11-22 |
| 28848 | SUPPL | 2013-10-31 |
| 16574 | SUPPL | 2013-10-31 |
| 16573 | SUPPL | 2013-06-18 |
| 6457 | SUPPL | 2013-06-12 |
| 6456 | SUPPL | 2012-08-27 |
| 16572 | SUPPL | 2011-10-20 |
| 28847 | SUPPL | 2011-10-17 |
| 16571 | SUPPL | 2011-03-28 |
| 6455 | SUPPL | 2011-03-25 |
| 28846 | SUPPL | 2010-11-03 |
| 6454 | SUPPL | 2010-11-03 |
| 37881 | SUPPL | 2010-10-28 |
| 16570 | SUPPL | 2010-10-28 |
| 28845 | SUPPL | 2007-11-26 |
| 6453 | SUPPL | 2007-11-26 |
| 6452 | SUPPL | 2007-11-26 |
| 6451 | SUPPL | 2007-11-26 |
| 37880 | SUPPL | 2007-11-19 |
| 37879 | SUPPL | 2007-11-19 |
| 37878 | SUPPL | 2007-11-19 |
| 16569 | SUPPL | 2007-11-19 |
| 6450 | SUPPL | 2007-03-15 |
| 21871 | ORIG | 2006-02-08 |
| 28844 | ORIG | 2006-01-19 |
| 37877 | ORIG | 2006-01-06 |