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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021629
Company: SANOFI AVENTIS US

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021629

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021629

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) 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
11/30/2022	SUPPL-42	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021629s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021629Orig1s042ltr.pdf
11/15/2019	SUPPL-40	Supplement	Letter (PDF) 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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
11/15/2019	SUPPL-39	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
12/20/2018	SUPPL-38	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
12/20/2018	SUPPL-37	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021629s037s038lbl.pdf
03/03/2015	SUPPL-31	Supplement		Label is not available on this site.
02/25/2015	SUPPL-30	Supplement	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	Supplement	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	Supplement	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	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 (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	Supplement	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	Supplement	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	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf
12/20/2005	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf

Labels for BLA 021629

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-42	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021629s042lbl.pdf
11/30/2022	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021629s042lbl.pdf
11/15/2019	SUPPL-39	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021629s039s040lbl.pdf
11/15/2019	SUPPL-39	Labeling-Package Insert	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-Package Insert	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
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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