FDA Approval for SOLIQUA 100/33 issued to SANOFI-AVENTIS US
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 208673
Company: SANOFI-AVENTIS US
Company: SANOFI-AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLIQUA 100/33 | INSULIN GLARGINE; LIXISENATIDE | 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2016 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208673Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2024 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 09/28/2023 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208673s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208673Orig1s013ltr.pdf | |
| 06/10/2022 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208673Orig1s012ltr.pdf | |
| 07/28/2021 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208673Orig1s011ltr.pdf | |
| 11/15/2019 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s008, s009ltr.pdf | |
| 11/15/2019 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s008, s009ltr.pdf | |
| 02/27/2019 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s007ltr.pdf | |
| 09/28/2017 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208673Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2023 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208673s013lbl.pdf | |
| 06/10/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf | |
| 06/10/2022 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf | |
| 07/28/2021 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf | |
| 07/28/2021 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf | |
| 07/28/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf | |
| 11/15/2019 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf | |
| 11/15/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf | |
| 11/15/2019 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf | |
| 11/15/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf | |
| 02/27/2019 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf | |
| 08/29/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf | |
| 11/21/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf |