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Biologic License Application (BLA): 761053
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCREVUS OCRELIZUMAB 30MG/1ML INJECTABLE;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
03/28/2017 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/03/2022 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761053Orig1s029, s030ltr.pdf
08/03/2022 SUPPL-29 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761053Orig1s029, s030ltr.pdf
05/15/2020 SUPPL-24 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf
11/06/2020 SUPPL-23 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s023ltr.pdf
12/14/2020 SUPPL-22 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s022ltr.pdf
01/10/2020 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s020ltr.pdf
07/16/2019 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761053s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761053Orig1s018ltr.pdf
11/12/2018 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761053s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761053Orig1s012ltr.pdf
11/02/2017 SUPPL-8 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2022 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf
08/03/2022 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf
12/14/2020 SUPPL-22 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s022lbl.pdf
11/06/2020 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf
05/15/2020 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf
01/10/2020 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf
07/16/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761053s018lbl.pdf
11/12/2018 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761053s012lbl.pdf
03/28/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf
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