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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 203314
Company: NOVO

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

Products on BLA 203314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRESIBA	INSULIN DEGLUDEC	300 UNITS/3ML (100 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No
TRESIBA	INSULIN DEGLUDEC	600 UNITS/3ML (200 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No
TRESIBA	INSULIN DEGLUDEC	1000 UNITS/10ML (100 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 203314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203314Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2022	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf
07/01/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf
11/15/2019	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203314Orig1s015, s016ltr.pdf
11/15/2019	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203314Orig1s015, s016ltr.pdf
11/21/2018	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s010ltr.pdf
08/09/2018	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s009ltr.pdf
03/26/2018	SUPPL-8	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/203314Orig1s008.pdf
06/24/2016	SUPPL-4	Supplement		Label is not available on this site.
12/16/2016	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203314s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203314Orig1s003ltr.pdf
07/08/2016	SUPPL-2	Supplement		Label is not available on this site.

Labels for BLA 203314

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2022	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf
07/01/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf
07/01/2022	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf
07/01/2022	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf
11/15/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf
11/15/2019	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf
11/15/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf
11/21/2018	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s010lbl.pdf
08/09/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s009lbl.pdf
03/26/2018	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf
12/16/2016	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203314s003lbl.pdf
09/25/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf

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