Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213051
Company: NOVO
Company: NOVO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RYBELSUS | SEMAGLUTIDE | 3MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| RYBELSUS | SEMAGLUTIDE | 7MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| RYBELSUS | SEMAGLUTIDE | 14MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| RYBELSUS | SEMAGLUTIDE | 1.5MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| RYBELSUS | SEMAGLUTIDE | 4MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| RYBELSUS | SEMAGLUTIDE | 9MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/20/2019 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213051Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2025 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf | |
| 10/17/2025 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf | |
| 10/17/2025 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf | |
| 11/01/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s023ltr.pdf | |
| 12/09/2024 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf | |
| 12/09/2024 | SUPPL-20 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf | |
| 01/24/2024 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s018ltr.pdf | |
| 01/12/2023 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213051Orig1s012ltr.pdf | |
| 06/10/2022 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213051Orig1s011ltr.pdf | |
| 04/30/2021 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf | |
| 01/16/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000, 213051Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/17/2025 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf | |
| 10/17/2025 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf | |
| 10/17/2025 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf | |
| 12/09/2024 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf | |
| 12/09/2024 | SUPPL-20 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf | |
| 11/01/2024 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf | |
| 11/01/2024 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf | |
| 01/24/2024 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf | |
| 01/12/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf | |
| 06/10/2022 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf | |
| 06/10/2022 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf | |
| 04/30/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf | |
| 04/30/2021 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf | |
| 01/16/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf | |
| 01/16/2020 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf | |
| 09/20/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf |