Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206321
Company: NOVO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAXENDA LIRAGLUTIDE RECOMBINANT 18MG/3ML (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
12/23/2014 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2018 SUPPL-9 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321s009ltr.pdf
10/19/2018 SUPPL-7 Efficacy Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321Orig1s007ltr.pdf
04/26/2017 SUPPL-6 Labeling-Medication Guide, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf
05/22/2017 SUPPL-5 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s005ltredt.pdf
04/26/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/206321Orig1s004.pdf
09/22/2016 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s003ltr.pdf
02/01/2016 SUPPL-2 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf
03/27/2015 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2018 SUPPL-7 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf
04/26/2017 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
04/26/2017 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
04/26/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
09/22/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf
09/22/2016 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf
03/27/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf
12/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf

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