Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125261
Company: CENTOCOR ORTHO BIOTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STELARA USTEKINUMAB 45MG/0.5ML INJECTABLE; INJECTION Prescription None No No
STELARA USTEKINUMAB 90MG/1ML 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
09/25/2009 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2018 SUPPL-147 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s147ltr.pdf
02/16/2018 SUPPL-141 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s141ltr.pdf
10/13/2017 SUPPL-138 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125261s138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s138ltr.pdf
02/15/2017 SUPPL-129 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s129ltr.pdf
03/04/2014 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125261Orig1s114ltr.pdf
09/20/2013 SUPPL-103 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s103ltr.pdf
04/29/2013 SUPPL-99 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf
01/25/2013 SUPPL-91 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s091ltr.pdf
05/21/2013 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s086ltr.pdf
05/02/2012 SUPPL-63 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0063ltr.pdf
06/14/2012 SUPPL-59 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0059ltr.pdf
04/06/2012 SUPPL-58 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0058ltr.pdf
05/31/2012 SUPPL-49 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0049ltr.pdf
10/20/2010 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf
12/30/2009 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s0001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2018 SUPPL-147 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf
02/16/2018 SUPPL-141 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf
10/13/2017 SUPPL-138 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125261s138lbl.pdf
03/04/2014 SUPPL-114 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf
09/20/2013 SUPPL-103 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf
05/21/2013 SUPPL-86 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf
04/29/2013 SUPPL-99 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf
01/25/2013 SUPPL-91 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf
06/14/2012 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf
05/31/2012 SUPPL-49 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf
10/20/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf
12/30/2009 SUPPL-1 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf
09/25/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf

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