Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021081
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LANTUS | INSULIN GLARGINE RECOMBINANT | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
| LANTUS SOLOSTAR | INSULIN GLARGINE RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;INJECTION | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2000 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21081ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/29/2023 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021081Orig1s078,s079ltr.pdf | |
| 06/29/2023 | SUPPL-78 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021081Orig1s078,s079ltr.pdf | |
| 06/07/2022 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021081s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021081Orig1s076ltr.pdf | |
| 11/15/2019 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf | |
| 11/15/2019 | SUPPL-73 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf | |
| 05/09/2019 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s072ltr.pdf | |
| 11/29/2018 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021081s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021081Orig1s071ltr.pdf | |
| 04/13/2016 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
| 06/16/2015 | SUPPL-64 | Supplement |
Label is not available on this site. |
||
| 07/17/2015 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s063ltr.pdf | |
| 02/25/2015 | SUPPL-62 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021081Orig1s062.pdf | |
| 09/05/2014 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
| 06/05/2013 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s057ltr.pdf | |
| 03/27/2013 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
| 05/16/2013 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s055ltr.pdf | |
| 08/14/2013 | SUPPL-49 | Supplement |
Label is not available on this site. |
||
| 09/09/2009 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021081s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021081s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021081Orig1s034.pdf | |
| 04/25/2007 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021081s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021081Orig1s024.pdf | |
| 03/15/2005 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021081_s017_Lantus.pdf | |
| 02/11/2005 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s014ltr.pdf | |
| 08/10/2004 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21081s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21081s011ltr.pdf | |
| 05/01/2003 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021081s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21081se2-005ltr.pdf | |
| 08/15/2002 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 01/31/2001 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 11/17/2000 | 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 |
|---|---|---|---|---|---|
| 06/29/2023 | SUPPL-79 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf | |
| 06/29/2023 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf | |
| 06/29/2023 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf | |
| 06/29/2023 | SUPPL-78 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf | |
| 06/07/2022 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021081s076lbl.pdf | |
| 06/07/2022 | SUPPL-76 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021081s076lbl.pdf | |
| 11/15/2019 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
| 11/15/2019 | SUPPL-74 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
| 11/15/2019 | SUPPL-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
| 11/15/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
| 11/15/2019 | SUPPL-73 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
| 05/09/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s072lbl.pdf | |
| 11/29/2018 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021081s071lbl.pdf | |
| 11/29/2018 | SUPPL-71 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021081s071lbl.pdf | |
| 07/17/2015 | SUPPL-63 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s063lbl.pdf | |
| 02/25/2015 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s062lbl.pdf | |
| 10/18/2013 | SUPPL-57 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s057lbl.pdf | |
| 05/16/2013 | SUPPL-55 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s055lbl.pdf | |
| 09/09/2009 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021081s034lbl.pdf | |
| 04/25/2007 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf | |
| 04/25/2007 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf | |
| 03/15/2005 | SUPPL-17 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s017lbl.pdf | |
| 02/11/2005 | SUPPL-14 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s014lbl.pdf | |
| 08/10/2004 | SUPPL-11 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21081s011lbl.pdf | |
| 05/01/2003 | SUPPL-5 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021081s025lbl.pdf | |
| 04/20/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf |