Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 209196
Company: SANOFI-AVENTIS US
Company: SANOFI-AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADMELOG | INSULIN LISPRO | 1000 UNITS/10ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
ADMELOG | INSULIN LISPRO | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
ADMELOG SOLOSTAR | INSULIN LISPRO | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, 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 |
---|---|---|---|---|---|---|---|
12/11/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2023 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209196Orig1s007ltr.pdf | |
11/15/2019 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf | |
11/15/2019 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf | |
11/01/2018 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209196Orig1s002ltr.pdf | |
10/19/2018 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/31/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf | |
08/31/2023 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf | |
11/15/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf | |
11/15/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf | |
11/01/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf | |
12/11/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf |