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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 208673
Company: SANOFI-AVENTIS US

Medication Guide

Summary Review

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

Products on BLA 208673

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLIQUA 100/33	INSULIN GLARGINE; LIXISENATIDE	300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 208673

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208673Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2023	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208673s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208673Orig1s013ltr.pdf
06/10/2022	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208673Orig1s012ltr.pdf
07/28/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208673Orig1s011ltr.pdf
11/15/2019	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s008, s009ltr.pdf
11/15/2019	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s008, s009ltr.pdf
02/27/2019	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208673Orig1s007ltr.pdf
09/28/2017	SUPPL-3	Supplement		Label is not available on this site.
08/29/2017	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208673Orig1s002ltr.pdf

Labels for BLA 208673

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208673s013lbl.pdf
06/10/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf
06/10/2022	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf
07/28/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf
07/28/2021	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf
07/28/2021	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208673s011lbl.pdf
11/15/2019	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf
11/15/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf
11/15/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf
11/15/2019	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf
02/27/2019	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf
08/29/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf
11/21/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf

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