Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761034
Company: GENENTECH INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECENTRIQ ATEZOLIZUMAB 1200MG/20ML 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
05/18/2016 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2019 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s019ltr.pdf
03/08/2019 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s018ltr.pdf
05/06/2019 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s014ltr.pdf
05/06/2019 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s013ltr.pdf
07/02/2018 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s012ltr.pdf
06/26/2018 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s011ltr.pdf
06/19/2018 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s010ltr.pdf
12/06/2018 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s009ltr_REPLACEMENT.pdf
06/14/2018 SUPPL-8 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034s008ltr.pdf
03/13/2018 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s005ltr.pdf
04/30/2018 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s003ltr.pdf
04/17/2017 SUPPL-1 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/06/2019 SUPPL-14 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s014lbl.pdf
05/06/2019 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s013lbl.pdf
03/18/2019 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s019lbl.pdf
03/08/2019 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s018lbl.pdf
12/06/2018 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s009lbl.pdf
07/02/2018 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s012lbl.pdf
06/26/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf
06/19/2018 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf
06/14/2018 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s008lbl.pdf
04/30/2018 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s003lbl.pdf
03/13/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s005lbl.pdf
04/17/2017 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf
05/18/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf

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