Application 125166
- Type
- BLA
- Sponsor
- ALEXION PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLIRIS | ECULIZUMAB | INJECTABLE; IV (INFUSION) | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals Inc. | BLA | Current |
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals Inc. | BLA | Current |
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals Inc. | BLA | Current |
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals I | BLA | Current |
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals Inc. | BLA | Current |
| 25682-001 | SOLIRIS | ECULIZUMAB | Alexion Pharmaceuticals Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82694 | SUPPL | 2025-06-30 |
| 81420 | SUPPL | 2025-03-04 |
| 81404 | SUPPL | 2025-03-03 |
| 81387 | SUPPL | 2025-03-03 |
| 79668 | SUPPL | 2024-09-20 |
| 79665 | SUPPL | 2024-09-20 |
| 78957 | SUPPL | 2024-07-02 |
| 78947 | SUPPL | 2024-07-01 |
| 78946 | SUPPL | 2024-07-01 |
| 77950 | SUPPL | 2024-03-25 |
| 77935 | SUPPL | 2024-03-25 |
| 77445 | SUPPL | 2024-02-09 |
| 77438 | SUPPL | 2024-02-09 |
| 69510 | SUPPL | 2021-12-07 |
| 65825 | SUPPL | 2021-01-06 |
| 65465 | SUPPL | 2020-12-02 |
| 65298 | SUPPL | 2020-11-23 |
| 62481 | SUPPL | 2020-04-17 |
| 60083 | SUPPL | 2019-09-20 |
| 59197 | SUPPL | 2019-07-25 |
| 59198 | SUPPL | 2019-06-28 |
| 55061 | SUPPL | 2018-07-31 |
| 55010 | SUPPL | 2018-07-26 |
| 55009 | SUPPL | 2018-07-26 |
| 54992 | SUPPL | 2018-07-26 |
| 54991 | SUPPL | 2018-07-26 |
| 52819 | SUPPL | 2018-03-06 |
| 52786 | SUPPL | 2018-03-01 |
| 50153 | SUPPL | 2017-10-24 |
| 50146 | SUPPL | 2017-10-23 |
| 46898 | SUPPL | 2017-01-19 |
| 46861 | SUPPL | 2017-01-13 |
| 31867 | SUPPL | 2016-04-15 |
| 31866 | SUPPL | 2015-12-08 |
| 18825 | SUPPL | 2015-12-08 |
| 9649 | SUPPL | 2015-12-08 |
| 43309 | SUPPL | 2015-07-20 |
| 9648 | SUPPL | 2014-10-14 |
| 39874 | SUPPL | 2014-05-02 |
| 18824 | SUPPL | 2014-05-02 |
| 9647 | SUPPL | 2014-05-02 |
| 9646 | SUPPL | 2014-05-02 |
| 31865 | SUPPL | 2012-12-27 |
| 18823 | SUPPL | 2011-09-23 |
| 24084 | ORIG | 2010-06-30 |
| 9645 | SUPPL | 2010-06-29 |
| 9644 | SUPPL | 2009-08-07 |
| 43308 | ORIG | 2007-05-17 |
| 31864 | ORIG | 2007-03-27 |
| 39873 | ORIG | 2007-03-23 |