Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125160
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMZIA | CERTOLIZUMAB PEGOL | 200MG | INJECTABLE; INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/22/2008 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000TOC2.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/08/2023 | SUPPL-309 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125160Orig1s309ltr.pdf |
| 12/22/2022 | SUPPL-305 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125160Orig1s305ltr.pdf | |
| 09/06/2019 | SUPPL-293 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s293lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125160Orig1s293ltr.pdf | |
| 02/27/2019 | SUPPL-289 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125160Orig1s289ltr.pdf | |
| 03/16/2018 | SUPPL-286 | Supplement |
Label is not available on this site. |
||
| 05/24/2018 | SUPPL-283 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125160Orig1s283ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125160Orig1s283.pdf | |
| 03/20/2018 | SUPPL-281 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125160Origs281ltr.pdf | |
| 06/14/2018 | SUPPL-279 | Supplement |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-270 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125160Orig1s270ltr.pdf | |
| 02/03/2016 | SUPPL-268 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s268lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s268ltr.pdf | |
| 02/26/2016 | SUPPL-266 | Supplement |
Label is not available on this site. |
||
| 10/19/2015 | SUPPL-264 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125160s264lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125160Orig1s264ltr.pdf | |
| 04/28/2016 | SUPPL-241 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s241ltr.pdf | |
| 03/28/2019 | SUPPL-237 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125160Orig1s237ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125160Orig1s237.pdf | |
| 10/17/2013 | SUPPL-215 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s215ltr_replace.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125160Orig1s215.pdf | |
| 09/27/2013 | SUPPL-213 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125160Orig1s213.pdf | |
| 10/05/2012 | SUPPL-192 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf | |
| 11/15/2012 | SUPPL-189 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s189ltr.pdf | |
| 10/05/2012 | SUPPL-186 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf | |
| 08/29/2012 | SUPPL-180 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s180ltr.pdf | |
| 04/17/2012 | SUPPL-174 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160s0174ltr.pdf | |
| 09/07/2011 | SUPPL-157 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125160s157ltr.pdf |
| 07/26/2011 | SUPPL-155 | Supplement |
Label is not available on this site. |
||
| 09/14/2011 | SUPPL-152 | Supplement |
Label is not available on this site. |
||
| 08/02/2012 | SUPPL-142 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0142lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s142ltr.pdf | |
| 10/06/2010 | SUPPL-126 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s126ltr.pdf |
| 12/21/2010 | SUPPL-122 | Supplement |
Label is not available on this site. |
||
| 07/29/2010 | SUPPL-111 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s111ltr.pdf | |
| 11/18/2009 | SUPPL-92 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125160s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125160s092ltr.pdf | |
| 05/13/2009 | SUPPL-80 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/bla/2009/125160Orig1s080.pdf |
| 12/31/2008 | SUPPL-38 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s038ltr.pdf |
| 12/22/2008 | SUPPL-36 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2022 | SUPPL-305 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf | |
| 09/06/2019 | SUPPL-293 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s293lbl.pdf | |
| 03/28/2019 | SUPPL-237 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.pdf | |
| 02/27/2019 | SUPPL-289 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf | |
| 02/27/2019 | SUPPL-289 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf | |
| 02/27/2019 | SUPPL-289 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf | |
| 05/24/2018 | SUPPL-283 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf | |
| 03/20/2018 | SUPPL-281 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s281lbl.pdf | |
| 01/04/2017 | SUPPL-270 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdf | |
| 04/28/2016 | SUPPL-241 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s241lbl.pdf | |
| 02/03/2016 | SUPPL-268 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s268lbl.pdf | |
| 10/19/2015 | SUPPL-264 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125160s264lbl.pdf | |
| 10/17/2013 | SUPPL-215 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf | |
| 09/27/2013 | SUPPL-213 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s213lbl.pdf | |
| 11/15/2012 | SUPPL-189 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189lbl.pdf | |
| 10/05/2012 | SUPPL-192 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf | |
| 10/05/2012 | SUPPL-186 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf | |
| 08/29/2012 | SUPPL-180 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s180lbl.pdf | |
| 08/02/2012 | SUPPL-142 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0142lbl.pdf | |
| 04/17/2012 | SUPPL-174 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174lbl.pdf | |
| 07/29/2010 | SUPPL-111 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111lbl.pdf | |
| 11/18/2009 | SUPPL-92 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125160s092lbl.pdf | |
| 04/22/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf |