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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215256
Company: NOVO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WEGOVY SEMAGLUTIDE 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
WEGOVY SEMAGLUTIDE 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
WEGOVY SEMAGLUTIDE 1MG/0.5ML (1MG/0.5ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
WEGOVY SEMAGLUTIDE 1.7MG/0.75ML (1.7MG/0.75ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
WEGOVY SEMAGLUTIDE 2.4MG/0.75ML (2.4MG/0.75ML) 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
06/04/2021 ORIG-1 Approval PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215256Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2023 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s007ltr.pdf
02/14/2023 SUPPL-6 Labeling-Medication Guide, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s006ltr.pdf
12/23/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215256Orig1s005ltr.pdf
08/24/2022 SUPPL-3 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2023 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf
02/14/2023 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf
02/14/2023 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf
12/23/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf
08/24/2022 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf
06/04/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf
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