Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125486
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GAZYVA OBINUTUZUMAB 1000MG/40ML 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
11/01/2013 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2016 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125486Orig1s013ltr.pdf
09/23/2015 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125486Orig1s010ltr.pdf
12/24/2014 SUPPL-9 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s009ltr.pdf
06/27/2014 SUPPL-8 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/26/2016 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf
09/23/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf
06/27/2014 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf
11/01/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf

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