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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218316
Company: NOVO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WEGOVY SEMAGLUTIDE 1.5MG TABLET;ORAL Prescription None Yes No
WEGOVY SEMAGLUTIDE 4MG TABLET;ORAL Prescription None Yes No
WEGOVY SEMAGLUTIDE 9MG TABLET;ORAL Prescription None Yes No
WEGOVY SEMAGLUTIDE 25MG TABLET;ORAL 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
12/22/2025 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218316Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2026 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s030;218316Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/29/2026 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s002lbl.pdf
01/29/2026 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s002lbl.pdf
12/22/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf
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