Application 125160
- Type
- BLA
- Sponsor
- UCB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIMZIA | CERTOLIZUMAB PEGOL | INJECTABLE; INJECTION | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-700 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
| 50474-710 | Cimzia | certolizumab pegol | UCB, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83473 | SUPPL | 2025-09-25 |
| 83472 | SUPPL | 2025-09-25 |
| 83426 | SUPPL | 2025-09-24 |
| 79633 | SUPPL | 2024-09-16 |
| 79600 | SUPPL | 2024-09-16 |
| 76563 | SUPPL | 2023-11-14 |
| 74208 | SUPPL | 2023-05-10 |
| 73046 | SUPPL | 2022-12-27 |
| 73045 | SUPPL | 2022-12-27 |
| 73023 | SUPPL | 2022-12-23 |
| 65850 | SUPPL | 2021-01-07 |
| 60743 | SUPPL | 2019-10-31 |
| 59946 | SUPPL | 2019-09-09 |
| 59945 | SUPPL | 2019-09-09 |
| 59940 | SUPPL | 2019-09-09 |
| 58923 | SUPPL | 2019-06-03 |
| 58186 | SUPPL | 2019-04-02 |
| 58185 | SUPPL | 2019-04-02 |
| 58155 | SUPPL | 2019-03-29 |
| 57843 | SUPPL | 2019-02-28 |
| 57832 | SUPPL | 2019-02-28 |
| 57844 | SUPPL | 2019-02-27 |
| 54361 | SUPPL | 2018-05-29 |
| 54351 | SUPPL | 2018-05-29 |
| 54350 | SUPPL | 2018-05-29 |
| 53486 | SUPPL | 2018-03-28 |
| 53481 | SUPPL | 2018-03-28 |
| 46677 | SUPPL | 2017-01-05 |
| 46671 | SUPPL | 2017-01-05 |
| 9640 | SUPPL | 2016-05-04 |
| 39868 | SUPPL | 2016-04-29 |
| 18819 | SUPPL | 2016-02-11 |
| 9641 | SUPPL | 2016-02-04 |
| 39869 | SUPPL | 2015-10-22 |
| 31860 | SUPPL | 2015-10-21 |
| 18818 | SUPPL | 2013-10-22 |
| 9639 | SUPPL | 2013-10-18 |
| 18817 | SUPPL | 2013-10-01 |
| 9638 | SUPPL | 2013-10-01 |
| 22792 | SUPPL | 2013-09-09 |
| 31858 | SUPPL | 2012-11-16 |
| 18816 | SUPPL | 2012-11-16 |
| 31859 | SUPPL | 2012-10-10 |
| 9637 | SUPPL | 2012-10-10 |
| 39867 | SUPPL | 2012-10-09 |
| 39866 | SUPPL | 2012-10-09 |
| 39865 | SUPPL | 2012-08-31 |
| 31857 | SUPPL | 2012-08-31 |
| 9635 | SUPPL | 2012-08-06 |
| 39864 | SUPPL | 2012-08-03 |
| 31856 | SUPPL | 2012-04-23 |
| 18815 | SUPPL | 2012-04-20 |
| 9636 | SUPPL | 2011-09-13 |
| 9634 | SUPPL | 2010-11-04 |
| 18814 | SUPPL | 2010-08-10 |
| 31855 | SUPPL | 2010-08-02 |
| 18813 | SUPPL | 2009-12-12 |
| 9633 | SUPPL | 2009-12-02 |
| 31854 | SUPPL | 2009-01-30 |
| 23949 | ORIG | 2008-09-04 |
| 44792 | ORIG | 2008-07-14 |
| 22791 | ORIG | 2008-07-07 |
| 18812 | ORIG | 2008-05-08 |
| 9632 | ORIG | 2008-04-30 |