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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761063
Company: ELI LILLY AND CO

Products on BLA 761063

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMGALITY	GALCANEZUMAB-GNLM	120MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761063

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761063Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2022	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761063Orig1s006ltr.pdf
12/05/2019	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s004ltr.pdf
06/04/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s003ltr.pdf

Labels for BLA 761063

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf
05/24/2022	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf
12/05/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s004lbl.pdf
06/04/2019	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf
09/27/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf

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