Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761156
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOGROYA | SOMAPACITAN-BECO | 10MG/1.5ML | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/28/2020 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761156Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761156Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/31/2025 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761156Orig1s006ltr.pdf | |
04/28/2023 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761156s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761156Orig1s005ltr.pdf | |
10/01/2021 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761156Orig1s001, s002ltr.pdf | |
10/01/2021 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761156Orig1s001, s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/31/2025 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf | |
01/31/2025 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf | |
04/28/2023 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761156s005lbl.pdf | |
10/01/2021 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf | |
10/01/2021 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf | |
10/01/2021 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf | |
10/01/2021 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf | |
08/28/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf |