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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761215
Company: ELI LILLY CO

Products on BLA 761215

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REZVOGLAR	INSULIN GLARGINE-AGLR	3ML(100UNITS/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2022	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761215s000Orig2s000.lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761215Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig2s000TOC.cfm
12/17/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761215s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761215Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2024	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761215s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761215Orig1s005ltr.pdf

Labels for BLA 761215

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761215s005lbl.pdf
11/16/2022	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761215s000Orig2s000.lbl.pdf
12/17/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761215s000lbl.pdf

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