Drugs@FDA: FDA-Approved Drugs

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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
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 N/A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21629ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-40 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
11/15/2019 SUPPL-39 Supplement

Label is not available on this site.

12/20/2018 SUPPL-38 Supplement

Label is not available on this site.

12/20/2018 SUPPL-37 Supplement

Label is not available on this site.

03/03/2015 SUPPL-31 Supplement

Label is not available on this site.

02/25/2015 SUPPL-30 Supplement

Label is not available on this site.

05/14/2014 SUPPL-29 Supplement

Label is not available on this site.

09/06/2013 SUPPL-28 Supplement

Label is not available on this site.

02/15/2013 SUPPL-27 Supplement

Label is not available on this site.

06/05/2013 SUPPL-26 Supplement

Label is not available on this site.

07/22/2013 SUPPL-24 Supplement

Label is not available on this site.

10/24/2008 SUPPL-15 Supplement

Label is not available on this site.

04/12/2007 SUPPL-10 Supplement

Label is not available on this site.

02/24/2009 SUPPL-8 Supplement

Label is not available on this site.

12/20/2005 SUPPL-2 Supplement

Label is not available on this site.

12/20/2005 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
04/16/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf

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