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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 209196
Company: SANOFI-AVENTIS US

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

Products on BLA 209196

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADMELOG	INSULIN LISPRO	1000 UNITS/10ML (100 UNITS/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No
ADMELOG	INSULIN LISPRO	300 UNITS/3ML (100 UNITS/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No
ADMELOG SOLOSTAR	INSULIN LISPRO	300 UNITS/3ML (100 UNITS/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 209196

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2023	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209196Orig1s007ltr.pdf
11/15/2019	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf
11/15/2019	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209196Orig1s004, s005ltr.pdf
11/01/2018	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209196Orig1s002ltr.pdf
10/19/2018	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 209196

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf
08/31/2023	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209196s007lbl.pdf
11/15/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf
11/15/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209196s004s005lbl.pdf
11/01/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209196s002lbl.pdf
12/11/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf

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