Drugs@FDA: FDA-Approved Drugs

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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