Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203314
Company: NOVO
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 Yes No
TRESIBA INSULIN DEGLUDEC 600 UNITS/3ML (200 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
TRESIBA INSULIN DEGLUDEC 1000 UNITS/10ML (100 UNITS/ML) SOLUTION;SUBCUTANEOUS 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
09/25/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD 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
11/15/2019 SUPPL-16 Labeling-Package Insert 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 Labeling-Package Insert, Labeling-Container/Carton Labels 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 Labeling 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 Efficacy-Labeling Change With Clinical Data 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 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s008ltr.pdf
06/24/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-3 Efficacy-New Patient Population 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 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-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
11/21/2018 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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