Drugs@FDA: FDA-Approved Drugs

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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
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 is not available on this site.
05/09/2019 SUPPL-72 Supplement

Label is not available on this site.
11/29/2018 SUPPL-71 Supplement

Label is not available on this site.
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 is not available on this site.
02/25/2015 SUPPL-62 Supplement

Label is not available on this site.
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 is not available on this site.
03/27/2013 SUPPL-56 Supplement

Label is not available on this site.
05/16/2013 SUPPL-55 Supplement

Label is not available on this site.
08/14/2013 SUPPL-49 Supplement

Label is not available on this site.
09/09/2009 SUPPL-34 Supplement

Label is not available on this site.
04/25/2007 SUPPL-24 Supplement

Label is not available on this site.
03/15/2005 SUPPL-17 Supplement

Label is not available on this site.
02/11/2005 SUPPL-14 Supplement

Label is not available on this site.
08/10/2004 SUPPL-11 Supplement

Label is not available on this site.
05/01/2003 SUPPL-5 Supplement

Label is not available on this site.
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
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
04/20/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf

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