Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125160
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125160Orig1s283ltr.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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125160Orig1s237ltr.pdf
10/17/2013 SUPPL-215 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s215ltr_replace.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
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-Container/Carton Labels 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
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

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