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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761109
Company: ELI LILLY AND CO

Products on BLA 761109

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYUMJEV	INSULIN LISPRO-AABC	100UNITS/ML(U-100)	INJECTABLE;INJECTION	Prescription	None	No	No
LYUMJEV	INSULIN LISPRO-AABC	200UNITS/ML(U-200)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761109Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761109Orig1s000_replacement_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761109Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/14/2022	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761109s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761109Orig1s004ltr.pdf
08/13/2021	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761109s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761109Orig1s003ltr.pdf

Labels for BLA 761109

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/14/2022	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761109s004lbl.pdf
08/13/2021	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761109s003lbl.pdf
06/15/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761109Orig1s000lbl.pdf

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