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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 208583
Company: NOVO

Medication Guide

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 208583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XULTOPHY 100/3.6	INSULIN DEGLUDEC; LIRAGLUTIDE	300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 208583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2023	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208583Orig1s021ltr.pdf
06/10/2022	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf
06/10/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf
11/15/2019	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf
11/15/2019	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf
08/08/2019	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s012ltr.pdf
02/27/2019	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf
02/27/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf
02/27/2019	SUPPL-8	Supplement	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf
02/01/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf
02/01/2019	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf
12/12/2017	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208583Orig1s001ltr.pdf

Labels for BLA 208583

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf
06/10/2022	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf
06/10/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf
06/10/2022	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf
06/10/2022	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf
06/10/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf
11/15/2019	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf
11/15/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf
11/15/2019	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf
11/15/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf
08/08/2019	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf
02/27/2019	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf
02/27/2019	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf
02/01/2019	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf
02/01/2019	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf
11/21/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf

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