Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125164
Company: HOFFMAN-LA ROCHE
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 |
---|---|---|---|---|---|
06/04/2024 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125164s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125164Orig1s091ltr.pdf | |
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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/04/2024 | SUPPL-91 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125164s091lbl.pdf | |
06/04/2024 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125164s091lbl.pdf | |
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 |