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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125545
Company: HOSPIRA INC

Medication Guide

Products on BLA 125545

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETACRIT	EPOETIN ALFA-EPBX	2,000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No
RETACRIT	EPOETIN ALFA-EPBX	3,000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No
RETACRIT	EPOETIN ALFA-EPBX	4,000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No
RETACRIT	EPOETIN ALFA-EPBX	10,000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No
RETACRIT	EPOETIN ALFA-EPBX	40,000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125545

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125545Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125545Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2023	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125545Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125545Orig1s022ltr.pdf
06/30/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125545Orig1s005ltr.pdf
01/18/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125545Orig1s003ltr.pdf

Labels for BLA 125545

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125545Orig1s022lbl.pdf
06/30/2020	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf
01/18/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf
05/15/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf

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