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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209637
Company: NOVO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OZEMPIC SEMAGLUTIDE 2MG/1.5ML (1.34MG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OZEMPIC SEMAGLUTIDE 4MG/3ML (1.34MG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OZEMPIC SEMAGLUTIDE 8MG/3ML (2.68MG/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
12/05/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209637s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2022 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s009ltr.pdf
04/12/2021 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209637Orig1s008ltr.pdf
11/27/2019 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s004ltr.pdf
01/16/2020 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209637Orig1s003ltr.pdf
04/09/2019 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/28/2022 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637Orig1s009lbl.pdf
04/12/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf
01/16/2020 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf
11/27/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf
11/27/2019 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf
04/09/2019 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf
12/05/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
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