Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761072
Company: PFIZER INC

• Medication Guide

Products on BLA 761072

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761072

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761072Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761072Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2023	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761072s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761072Orig1s009Correctedltr.pdf
01/16/2020	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761072s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761072Orig1s006ltr.pdf

Labels for BLA 761072

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761072s009lbl.pdf
01/16/2020	SUPPL-6	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761072s006lbl.pdf
12/13/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf