Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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;IV (INFUSION), SUBCUTANEOUS Prescription None Yes Yes
APIDRA INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription None Yes Yes
APIDRA SOLOSTAR INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML INJECTABLE;SUBCUTANEOUS Prescription None Yes 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
04/16/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21629ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-629_Apidra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/25/2015 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021629s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021629Orig1s030ltr.pdf
05/14/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021629Orig1s029ltr.pdf
09/06/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021629s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021629Orig1s028ltr.pdf
02/15/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/05/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/22/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/24/2008 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021629s015ltr.pdf
04/12/2007 SUPPL-10 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021629s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021629s010ltr.pdf
02/24/2009 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021629s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021629Orig1s008.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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf
02/24/2009 SUPPL-8 Labeling-Package Insert 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

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