Application 125319
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ILARIS | CANAKINUMAB | INJECTABLE; SUBCUTANEOUS | 180MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0582 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0582 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0734 | Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80145 | SUPPL | 2024-11-05 |
| 80144 | SUPPL | 2024-11-05 |
| 80120 | SUPPL | 2024-11-05 |
| 75312 | SUPPL | 2023-08-29 |
| 75300 | SUPPL | 2023-08-28 |
| 64650 | SUPPL | 2020-09-22 |
| 64649 | SUPPL | 2020-09-22 |
| 64625 | SUPPL | 2020-09-21 |
| 63605 | SUPPL | 2020-06-17 |
| 63604 | SUPPL | 2020-06-17 |
| 63594 | SUPPL | 2020-06-17 |
| 56359 | SUPPL | 2018-11-08 |
| 50941 | SUPPL | 2017-12-29 |
| 50940 | SUPPL | 2017-12-29 |
| 50939 | SUPPL | 2017-12-29 |
| 46525 | SUPPL | 2016-12-23 |
| 46510 | SUPPL | 2016-12-22 |
| 45393 | SUPPL | 2016-09-27 |
| 45392 | SUPPL | 2016-09-27 |
| 45391 | SUPPL | 2016-09-27 |
| 45399 | SUPPL | 2016-09-26 |
| 45398 | SUPPL | 2016-09-26 |
| 45397 | SUPPL | 2016-09-26 |
| 9697 | SUPPL | 2016-07-26 |
| 39918 | SUPPL | 2016-07-22 |
| 39917 | SUPPL | 2014-10-21 |
| 9696 | SUPPL | 2014-10-21 |
| 43932 | ORIG | 2013-05-15 |
| 39916 | SUPPL | 2013-05-13 |
| 9695 | SUPPL | 2013-05-13 |
| 31920 | SUPPL | 2012-10-15 |
| 39915 | SUPPL | 2012-10-12 |
| 31919 | SUPPL | 2012-04-02 |
| 18861 | SUPPL | 2012-04-02 |
| 44800 | ORIG | 2009-08-26 |
| 43318 | ORIG | 2009-08-26 |
| 31918 | ORIG | 2009-06-30 |
| 18860 | ORIG | 2009-06-29 |