Application 203971
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XOFIGO | RADIUM RA-223 DICHLORIDE | SOLUTION;INTRAVENOUS | 162mCi/6ML (27mCi/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-208 | Xofigo | Radium Ra 223 dichloride | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61241 | SUPPL | 2019-12-11 |
| 61230 | SUPPL | 2019-12-11 |
| 55470 | SUPPL | 2018-09-13 |
| 55381 | SUPPL | 2018-09-05 |
| 52507 | SUPPL | 2018-02-08 |
| 52397 | SUPPL | 2018-02-02 |
| 19505 | SUPPL | 2016-03-22 |
| 10261 | SUPPL | 2016-03-22 |
| 43448 | ORIG | 2013-06-21 |
| 24453 | ORIG | 2013-06-21 |
| 32483 | ORIG | 2013-05-16 |
| 19504 | ORIG | 2013-05-15 |