U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 021081
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
06/07/2022 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
06/07/2022 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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.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-73 Labeling-Container/Carton Labels 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
11/15/2019 SUPPL-73 Labeling-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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf
04/25/2007 SUPPL-24 Labeling-Package Insert 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
Back to Top