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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 205692
Company: ELI LILLY AND CO

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

Summary Review

Products on BLA 205692

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 205692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Letter (PDF) Review Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2021	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205692Orig1s033ltr.pdf
11/15/2019	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
11/15/2019	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
11/15/2019	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205692Orig1021, s024, s025ltr.pdf
09/05/2018	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205692s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205692Orig1s019ltr.pdf
06/01/2016	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s005ltr.pdf
06/17/2016	SUPPL-2	Supplement		Label is not available on this site.
06/17/2016	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 205692

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2021	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
07/20/2021	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
07/20/2021	SUPPL-33	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205692s033lbl.pdf
11/15/2019	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
11/15/2019	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205692s021s024s025lbl.pdf
09/05/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205692s019lbl.pdf
06/01/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf
12/16/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf

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