Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
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 Type 4 - New Combination STANDARD 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/drugsatfda_docs/nda/2016/208583Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2019 SUPPL-11 Efficacy-New Indication 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 Efficacy-New Indication 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 Efficacy-New Indication 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
02/01/2019 SUPPL-3 Efficacy-New Indication 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 Efficacy-New Indication 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 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208583Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
02/27/2019 SUPPL-8 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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