Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761086
Company: AMGEN INC

• Medication Guide

Products on BLA 761086

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVSOLA	INFLIXIMAB-AXXQ	100MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761086Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761086Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761086s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761086Orig1s001ltr.pdf

Labels for BLA 761086

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2021	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761086s001lbl.pdf
09/09/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761086s001lbl.pdf
12/06/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf