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): 021629
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APIDRA INSULIN GLULISINE RECOMBINANT 1000 UNITS/10ML (100 UNITS/ML) INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription None No No
APIDRA INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
APIDRA SOLOSTAR INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML INJECTABLE;SUBCUTANEOUS Prescription None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf
11/15/2019 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf
12/20/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
12/20/2018 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
12/20/2018 SUPPL-37 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
12/20/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
02/25/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021629s030lbl.pdf
05/14/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf
09/06/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021629s028lbl.pdf
02/24/2009 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf
02/24/2009 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf
10/24/2008 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf
04/12/2007 SUPPL-10 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021629s010lbl.pdf
12/20/2005 SUPPL-2 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf
12/20/2005 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf
04/16/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf
Back to Top