Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125377
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YERVOY IPILIMUMAB 3MG 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
03/25/2011 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2019 SUPPL-102 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125377Orig1s102ltr.pdf
07/10/2018 SUPPL-96 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s096ltr.pdf
04/16/2018 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s094ltr.pdf
02/08/2018 SUPPL-93 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s093ltr.pdf
12/13/2017 SUPPL-91 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s091ltr.pdf
07/21/2017 SUPPL-87 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s087ltr.pdf
10/20/2017 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s086ltr.pdf
03/03/2017 SUPPL-84 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s084ltr.pdf
08/17/2015 SUPPL-74 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s074ltr.pdf
10/28/2015 SUPPL-73 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s073ltr.pdf
03/19/2015 SUPPL-72 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s072ltr.pdf
03/16/2015 SUPPL-71 Supplement

Label is not available on this site.

12/05/2013 SUPPL-55 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s055ltr.pdf
05/22/2013 SUPPL-44 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s044ltr.pdf
10/26/2012 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377Orig1s033ltr.pdf
02/16/2012 SUPPL-16 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377s016ltr.pdf
07/28/2011 SUPPL-8 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/08/2019 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf
07/10/2018 SUPPL-96 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf
04/16/2018 SUPPL-94 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf
02/08/2018 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf
12/13/2017 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf
10/20/2017 SUPPL-86 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf
07/21/2017 SUPPL-87 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf
10/28/2015 SUPPL-73 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf
08/17/2015 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf
08/17/2015 SUPPL-74 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf
03/19/2015 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf
12/05/2013 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf
05/22/2013 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf
10/26/2012 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf
03/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf

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