Application 125289
- Type
- BLA
- Sponsor
- CENTOCOR ORTHO BIOTECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMPONI | GOLIMUMAB | INJECTABLE; INJECTION | 50MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57894-070 | Simponi | golimumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-070 | Simponi | golimumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-071 | Simponi | golimumab | Janssen Biotech, Inc. | BLA | Current |
| 57894-071 | Simponi | golimumab | Janssen Biotech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83907 | SUPPL | 2025-10-23 |
| 83906 | SUPPL | 2025-10-23 |
| 83900 | SUPPL | 2025-10-23 |
| 83684 | SUPPL | 2025-10-07 |
| 83677 | SUPPL | 2025-10-07 |
| 83639 | SUPPL | 2025-10-03 |
| 83610 | SUPPL | 2025-10-01 |
| 82793 | SUPPL | 2025-07-11 |
| 82002 | SUPPL | 2025-04-25 |
| 76616 | SUPPL | 2023-11-17 |
| 73919 | SUPPL | 2023-03-31 |
| 73912 | SUPPL | 2023-03-31 |
| 60109 | SUPPL | 2019-09-25 |
| 60101 | SUPPL | 2019-09-25 |
| 60100 | SUPPL | 2019-09-25 |
| 52911 | SUPPL | 2018-03-12 |
| 52877 | SUPPL | 2018-03-08 |
| 52549 | SUPPL | 2018-02-09 |
| 52531 | SUPPL | 2018-02-09 |
| 50426 | SUPPL | 2017-11-15 |
| 50406 | SUPPL | 2017-11-14 |
| 48804 | SUPPL | 2017-06-22 |
| 48802 | SUPPL | 2017-06-22 |
| 48418 | SUPPL | 2017-05-17 |
| 47055 | SUPPL | 2017-01-31 |
| 47062 | SUPPL | 2017-01-30 |
| 18852 | SUPPL | 2016-01-12 |
| 31906 | SUPPL | 2016-01-11 |
| 39906 | SUPPL | 2015-06-19 |
| 31905 | SUPPL | 2015-06-18 |
| 31904 | SUPPL | 2014-12-23 |
| 22798 | SUPPL | 2014-08-01 |
| 31902 | SUPPL | 2013-12-31 |
| 18851 | SUPPL | 2013-12-30 |
| 39904 | SUPPL | 2013-11-15 |
| 31901 | SUPPL | 2013-11-14 |
| 39902 | SUPPL | 2013-05-21 |
| 18849 | SUPPL | 2013-05-21 |
| 18848 | SUPPL | 2013-05-21 |
| 31899 | SUPPL | 2013-05-16 |
| 31898 | SUPPL | 2013-05-16 |
| 9683 | SUPPL | 2013-05-16 |
| 9684 | SUPPL | 2013-05-08 |
| 18850 | SUPPL | 2013-05-06 |
| 39903 | SUPPL | 2013-04-30 |
| 31900 | SUPPL | 2013-04-30 |
| 39901 | SUPPL | 2012-11-28 |
| 9682 | SUPPL | 2012-11-26 |
| 39900 | SUPPL | 2012-03-15 |
| 31896 | SUPPL | 2012-01-24 |
| 39899 | SUPPL | 2012-01-11 |
| 31897 | SUPPL | 2012-01-03 |
| 23950 | ORIG | 2011-12-20 |
| 9681 | SUPPL | 2011-09-13 |
| 31895 | SUPPL | 2011-03-25 |
| 9679 | SUPPL | 2011-01-06 |
| 18847 | SUPPL | 2011-01-05 |
| 9680 | SUPPL | 2010-10-19 |
| 39898 | SUPPL | 2010-08-10 |
| 9678 | SUPPL | 2010-08-03 |
| 18846 | SUPPL | 2009-12-11 |
| 9677 | SUPPL | 2009-11-25 |
| 44797 | ORIG | 2009-06-05 |
| 43315 | ORIG | 2009-06-05 |
| 9676 | ORIG | 2009-05-06 |
| 39897 | ORIG | 2009-05-05 |
| 51154 | SUPPL | 1900-01-01 |
| 51153 | SUPPL | 1900-01-01 |
| 51152 | SUPPL | 1900-01-01 |
| 51151 | SUPPL | 1900-01-01 |