Application 125104
- Type
- BLA
- Sponsor
- BIOGEN IDEC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYSABRI | NATALIZUMAB | VIAL; SINGLE-USE | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
| 64406-008 | TYSABRI | natalizumab | Biogen Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81664 | SUPPL | 2025-03-21 |
| 81663 | SUPPL | 2025-03-21 |
| 81637 | SUPPL | 2025-03-19 |
| 75971 | SUPPL | 2023-10-27 |
| 75970 | SUPPL | 2023-10-27 |
| 75297 | SUPPL | 2023-08-28 |
| 73980 | SUPPL | 2023-04-12 |
| 73979 | SUPPL | 2023-04-12 |
| 73975 | SUPPL | 2023-04-12 |
| 73974 | SUPPL | 2023-04-12 |
| 69560 | SUPPL | 2021-12-15 |
| 69559 | SUPPL | 2021-12-15 |
| 69558 | SUPPL | 2021-12-15 |
| 69548 | SUPPL | 2021-12-14 |
| 69547 | SUPPL | 2021-12-14 |
| 64887 | SUPPL | 2020-10-09 |
| 64853 | SUPPL | 2020-10-06 |
| 63608 | SUPPL | 2020-06-19 |
| 63621 | SUPPL | 2020-06-18 |
| 63620 | SUPPL | 2020-06-18 |
| 63619 | SUPPL | 2020-06-18 |
| 63618 | SUPPL | 2020-06-18 |
| 63609 | SUPPL | 2020-06-18 |
| 59605 | SUPPL | 2019-08-07 |
| 59581 | SUPPL | 2019-08-06 |
| 59580 | SUPPL | 2019-08-06 |
| 53777 | SUPPL | 2018-04-23 |
| 53776 | SUPPL | 2018-04-23 |
| 53754 | SUPPL | 2018-04-20 |
| 53753 | SUPPL | 2018-04-20 |
| 49492 | SUPPL | 2017-08-21 |
| 49438 | SUPPL | 2017-08-17 |
| 49437 | SUPPL | 2017-08-17 |
| 45526 | SUPPL | 2016-10-12 |
| 39845 | SUPPL | 2016-05-20 |
| 18792 | SUPPL | 2016-05-20 |
| 9611 | SUPPL | 2016-05-20 |
| 9610 | SUPPL | 2016-05-20 |
| 39844 | SUPPL | 2015-05-13 |
| 31833 | SUPPL | 2015-05-13 |
| 24357 | SUPPL | 2014-01-16 |
| 39843 | SUPPL | 2013-12-17 |
| 39842 | SUPPL | 2013-12-17 |
| 31832 | SUPPL | 2013-12-17 |
| 18791 | SUPPL | 2013-12-17 |
| 9609 | SUPPL | 2013-12-17 |
| 9608 | SUPPL | 2013-12-17 |
| 22784 | SUPPL | 2013-10-23 |
| 39841 | SUPPL | 2013-06-04 |
| 9607 | SUPPL | 2013-05-28 |
| 31831 | SUPPL | 2012-01-31 |
| 9606 | SUPPL | 2012-01-31 |
| 18790 | SUPPL | 2012-01-27 |
| 24083 | ORIG | 2012-01-18 |
| 39840 | SUPPL | 2011-09-27 |
| 18789 | SUPPL | 2011-04-07 |
| 18788 | SUPPL | 2011-04-07 |
| 39839 | SUPPL | 2009-09-16 |
| 9605 | SUPPL | 2008-11-03 |
| 9604 | SUPPL | 2008-11-03 |
| 18786 | SUPPL | 2008-10-31 |
| 9603 | SUPPL | 2008-01-23 |
| 39838 | SUPPL | 2008-01-15 |
| 39837 | SUPPL | 2006-06-06 |
| 31830 | SUPPL | 2006-06-06 |
| 22783 | ORIG | 2005-03-08 |
| 18785 | ORIG | 2004-11-24 |
| 9602 | ORIG | 2004-11-24 |
| 18787 | SUPPL | 2004-11-23 |