Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215256
Company: NOVO
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 |
---|---|---|---|---|---|
03/08/2024 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s011ltr.pdf | |
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 |
---|---|---|---|---|---|
03/08/2024 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf | |
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 |