Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125118
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORENCIA ABATACEPT 250MG INJECTABLE; IV (INFUSION) 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
12/23/2005 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125118rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125118_s0000_OrenciaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2019 SUPPL-224 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125118s224lbl.pdf
03/30/2017 SUPPL-211 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s211ltr.pdf
06/30/2017 SUPPL-209 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s209ltr.pdf
06/07/2016 SUPPL-200 Supplement

Label is not available on this site.

12/30/2014 SUPPL-179 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125118Orig1s179ltr.pdf
12/20/2013 SUPPL-171 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125118Orig1s171ltr.pdf
02/17/2012 SUPPL-138 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf
08/18/2011 SUPPL-131 Supplement

Label is not available on this site.

07/29/2011 SUPPL-122 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125118s0122ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125118Orig1s122.pdf
06/23/2011 SUPPL-107 Supplement Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125118Orig1s107.pdf
08/25/2009 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf
03/21/2008 SUPPL-59 Supplement

Label is not available on this site.

04/07/2008 SUPPL-45 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf
12/12/2006 SUPPL-18 Supplement

Label is not available on this site.

03/13/2007 SUPPL-16 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2019 SUPPL-224 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125118s224lbl.pdf
06/30/2017 SUPPL-209 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf
03/30/2017 SUPPL-211 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s211lbl.pdf
12/30/2014 SUPPL-179 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf
12/20/2013 SUPPL-171 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf
02/17/2012 SUPPL-138 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf
08/25/2009 SUPPL-86 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf
03/13/2007 SUPPL-16 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf
12/23/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf

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