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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125164
Company: HOFFMAN-LA ROCHE

Medication Guide

Products on BLA 125164

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRCERA	METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA	0.6MG/KG	SOLUTION; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125164

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2007	ORIG-1	Approval		N/A	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125164lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125164TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-89	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125164s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125164Orig1s089ltr.pdf
03/31/2023	SUPPL-87	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125164s087lblcorrection.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125164Orig1s087ltr.pdf
08/30/2022	SUPPL-86	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125164s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125164Orig1s086ltr.pdf
06/07/2018	SUPPL-78	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125164Orig1s078ltr.pdf
04/28/2016	SUPPL-73	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf
04/28/2016	SUPPL-72	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf
04/28/2016	SUPPL-71	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf
08/21/2015	SUPPL-70	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125164s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125164Orig1s070ltr.pdf
10/01/2014	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125164s062lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125164Orig1s062ltr.pdf
07/07/2008	SUPPL-5	Supplement		Label is not available on this site.

Labels for BLA 125164

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-89	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125164s089lbl.pdf
03/31/2023	SUPPL-87	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125164s087lblcorrection.pdf
08/30/2022	SUPPL-86	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125164s086lbl.pdf
06/07/2018	SUPPL-78	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf
04/28/2016	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf
04/28/2016	SUPPL-72	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf
04/28/2016	SUPPL-71	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf
08/21/2015	SUPPL-70	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125164s070lbl.pdf
10/01/2014	SUPPL-62	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125164s062lbledt.pdf
11/14/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125164lbl.pdf

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