Application 125504
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COSENTYX | SECUKINUMAB | INJECTABLE;INJECTION | 150MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0639 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-1056 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-1056 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-1056 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-1056 | COSENTYX | secukinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85725 | SUPPL | 2026-04-21 |
| 85724 | SUPPL | 2026-04-21 |
| 85723 | SUPPL | 2026-04-21 |
| 85720 | SUPPL | 2026-04-20 |
| 85717 | SUPPL | 2026-04-20 |
| 85376 | SUPPL | 2026-03-16 |
| 83065 | SUPPL | 2025-08-21 |
| 83064 | SUPPL | 2025-08-07 |
| 81677 | SUPPL | 2025-03-24 |
| 81676 | SUPPL | 2025-03-24 |
| 81568 | SUPPL | 2025-03-14 |
| 81561 | SUPPL | 2025-03-14 |
| 79849 | SUPPL | 2024-10-09 |
| 79846 | SUPPL | 2024-10-09 |
| 79444 | SUPPL | 2024-08-20 |
| 79443 | SUPPL | 2024-08-20 |
| 79434 | SUPPL | 2024-08-19 |
| 76660 | SUPPL | 2023-11-24 |
| 76650 | SUPPL | 2023-11-22 |
| 76042 | SUPPL | 2023-11-02 |
| 76034 | SUPPL | 2023-11-02 |
| 75693 | SUPPL | 2023-10-10 |
| 75685 | SUPPL | 2023-10-10 |
| 74896 | SUPPL | 2023-07-26 |
| 74895 | SUPPL | 2023-07-26 |
| 74893 | SUPPL | 2023-07-26 |
| 74886 | SUPPL | 2023-07-25 |
| 74885 | SUPPL | 2023-07-25 |
| 74884 | SUPPL | 2023-07-25 |
| 74235 | SUPPL | 2023-05-12 |
| 74234 | SUPPL | 2023-05-12 |
| 69783 | SUPPL | 2021-12-27 |
| 69782 | SUPPL | 2021-12-27 |
| 69763 | SUPPL | 2021-12-27 |
| 69762 | SUPPL | 2021-12-27 |
| 67676 | SUPPL | 2021-06-03 |
| 67644 | SUPPL | 2021-06-01 |
| 67643 | SUPPL | 2021-06-01 |
| 63595 | SUPPL | 2020-06-17 |
| 63591 | SUPPL | 2020-06-17 |
| 63590 | SUPPL | 2020-06-17 |
| 61742 | SUPPL | 2020-01-30 |
| 61739 | SUPPL | 2020-01-30 |
| 61738 | SUPPL | 2020-01-30 |
| 59620 | SUPPL | 2019-08-07 |
| 59614 | SUPPL | 2019-08-07 |
| 54645 | SUPPL | 2018-06-21 |
| 51903 | SUPPL | 2018-01-26 |
| 51856 | SUPPL | 2018-01-26 |
| 49789 | SUPPL | 2017-09-19 |
| 49764 | SUPPL | 2017-09-18 |
| 18927 | SUPPL | 2016-01-26 |
| 18926 | SUPPL | 2016-01-26 |
| 31984 | SUPPL | 2016-01-20 |
| 9771 | SUPPL | 2016-01-20 |
| 24377 | ORIG | 2015-02-19 |
| 22816 | ORIG | 2015-02-19 |
| 31983 | ORIG | 2015-01-23 |
| 18925 | ORIG | 2015-01-22 |