Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 208583
Company: NOVO
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
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
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 is not available on this site.

02/27/2019 SUPPL-11 Supplement

Label is not available on this site.

02/27/2019 SUPPL-10 Supplement

Label is not available on this site.

02/27/2019 SUPPL-8 Supplement

Label is not available on this site.

02/01/2019 SUPPL-3 Supplement

Label is not available on this site.

02/01/2019 SUPPL-2 Supplement

Label is not available on this site.

12/12/2017 SUPPL-1 Supplement

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-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-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
11/21/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf

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