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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125477
Company: ELI LILLY AND CO

Summary Review

Products on BLA 125477

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYRAMZA	RAMUCIRUMAB	100MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No
CYRAMZA	RAMUCIRUMAB	500MG/50ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125477

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2014	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2022	SUPPL-42	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125477s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125477Orig1s042ltr.pdf
06/15/2021	SUPPL-39	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125477s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125477Orig1s039ltr.pdf
07/06/2020	SUPPL-37	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s037ltr.pdf
02/20/2020	SUPPL-36	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s036ltr.pdf
11/05/2019	SUPPL-35	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s035ltr.pdf
05/29/2020	SUPPL-34	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s034ltr.pdf
07/31/2019	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s033ltr.pdf
11/26/2018	SUPPL-31	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s031ltr.pdf
08/14/2018	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s030REPLACEMENT LETTER.pdf
05/10/2019	SUPPL-29	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s029ltr.pdf
04/24/2015	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125477Orig1s011ltr.pdf
12/12/2014	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s007ltr.pdf
11/05/2014	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s002ltr.pdf

Labels for BLA 125477

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2022	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125477s042lbl.pdf
06/15/2021	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125477s039lbl.pdf
07/06/2020	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s037lbl.pdf
05/29/2020	SUPPL-34	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s034lbl.pdf
02/20/2020	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s036lbl.pdf
07/31/2019	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf
08/14/2018	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf
04/24/2015	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf
12/12/2014	SUPPL-7	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf
11/05/2014	SUPPL-2	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf
04/21/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf

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