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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125288
Company: BRISTOL MYERS SQUIBB

Medication Guide

Products on BLA 125288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NULOJIX	BELATACEPT	250MG	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2011	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125288s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125288Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2021	SUPPL-101	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125288s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125288Orig1s101ltr.pdf
04/13/2018	SUPPL-75	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125288Orig1s075ltr.pdf
11/09/2017	SUPPL-74	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s074ltr.pdf
05/09/2017	SUPPL-72	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s072ltr.pdf
02/02/2017	SUPPL-70	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s070ltr.pdf
09/30/2014	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s062ltr.pdf
04/15/2014	SUPPL-59	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s059ltr.pdf
04/08/2013	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125288Orig1s030ltr.pdf

Labels for BLA 125288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2021	SUPPL-101	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125288s101lbl.pdf
04/13/2018	SUPPL-75	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf
11/09/2017	SUPPL-74	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf
11/09/2017	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf
02/02/2017	SUPPL-70	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s070lbl.pdf
09/30/2014	SUPPL-62	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf
04/15/2014	SUPPL-59	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf
04/08/2013	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf
06/15/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf

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