Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125554
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPDIVO NIVOLUMAB 40MG/4ML INJECTABLE;INJECTION Prescription None TBD 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
12/22/2014 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125554Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2017 SUPPL-41 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s041ltr.pdf
09/06/2017 SUPPL-40 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s040ltr.pdf
07/31/2017 SUPPL-34 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s034ltr.pdf
04/25/2017 SUPPL-31 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s031ltr.pdf
02/02/2017 SUPPL-24 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s024ltr.pdf
11/10/2016 SUPPL-22 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s022ltr.pdf
05/17/2016 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s019ltr.pdf
09/13/2016 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf
09/13/2016 SUPPL-17 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf
10/04/2016 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s016ltr.pdf
11/23/2015 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s012ltr.pdf
01/23/2016 SUPPL-7 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s007ltr.pdf
10/09/2015 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s005ltr.pdf
09/30/2015 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s002ltr.pdf
11/23/2015 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/2017 SUPPL-41 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf
09/06/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf
07/31/2017 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf
04/25/2017 SUPPL-31 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s031lbl.pdf
02/02/2017 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf
11/10/2016 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf
10/04/2016 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf
09/13/2016 SUPPL-18 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf
09/13/2016 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf
05/17/2016 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf
11/23/2015 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf
11/23/2015 SUPPL-1 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf
10/09/2015 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf
09/30/2015 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf
12/22/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf

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