Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761034
Company: GENENTECH INC
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 |
|---|---|---|---|---|---|
| 04/13/2021 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s041ltr.pdf | |
| 02/17/2021 | SUPPL-38 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 02/17/2021 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 02/17/2021 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 02/17/2021 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 02/17/2021 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 02/17/2021 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf | |
| 12/18/2020 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s031, s032ltr.pdf | |
| 12/18/2020 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s031, s032ltr.pdf | |
| 09/30/2020 | SUPPL-29 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s029ltr.pdf | |
| 07/30/2020 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s028ltr.pdf | |
| 05/18/2020 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s027ltr.pdf | |
| 05/29/2020 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s025ltr.pdf | |
| 12/03/2019 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s021ltr.pdf | |
| 11/10/2020 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s020ltr.pdf | |
| 03/18/2019 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761034Orig1s019.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 |
|---|---|---|---|---|---|
| 04/13/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s041lbl.pdf | |
| 02/17/2021 | SUPPL-38 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 02/17/2021 | SUPPL-37 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 02/17/2021 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 02/17/2021 | SUPPL-35 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 02/17/2021 | SUPPL-34 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 02/17/2021 | SUPPL-33 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf | |
| 12/18/2020 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf | |
| 12/18/2020 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf | |
| 11/10/2020 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s020lbl.pdf | |
| 11/10/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s020lbl.pdf | |
| 09/30/2020 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s029lbl.pdf | |
| 07/30/2020 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf | |
| 05/29/2020 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s025lbl.pdf | |
| 05/18/2020 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s027lbl.pdf | |
| 12/03/2019 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s021lbl.pdf | |
| 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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