Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125547
Company: ELI LILLY CO

• Summary Review

Products on BLA 125547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PORTRAZZA	NECITUMUMAB	800MG/50ML	INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125547Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125547Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125547Orig1s000SumR.pdf

Labels for BLA 125547

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf