Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761069
Company: ASTRAZENECA UK LTD
Company: ASTRAZENECA UK LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMFINZI | DURVALUMAB | 50MG/ML | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 05/01/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761069Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761069Orig1s044ltr.pdf | |
| 06/16/2023 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761069Orig1s042ltr.pdf | |
| 10/21/2022 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761069Orig1s036ltr.pdf | |
| 09/02/2022 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761069Orig1s035ltr.pdf | |
| 11/10/2022 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761069Orig1s033ltr.pdf | |
| 05/11/2022 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761069Orig1s032.ltr.pdf | |
| 02/19/2021 | SUPPL-29 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761069Orig1s029ltr.pdf | |
| 07/15/2021 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761069Orig1s028ltr.pdf | |
| 11/18/2020 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s023, s024, s025ltr.pdf | |
| 11/18/2020 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s023, s024, s025ltr.pdf | |
| 11/18/2020 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s023, s024, s025ltr.pdf | |
| 06/05/2020 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s020ltr.pdf | |
| 03/27/2020 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s018ltr.pdf | |
| 08/26/2019 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761069Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761069Orig1s016ltr.pdf | |
| 07/19/2019 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761069s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761069Orig1s013ltr.pdf | |
| 11/10/2020 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s012ltr.pdf | |
| 02/16/2018 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761069Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s044lbl.pdf | |
| 06/16/2023 | SUPPL-42 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s042lbl.pdf | |
| 06/16/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s042lbl.pdf | |
| 11/10/2022 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s033lbl.pdf | |
| 10/21/2022 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s036lbl.pdf | |
| 09/02/2022 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s035lbl.pdf | |
| 05/11/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s032lbl.pdf | |
| 07/15/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s028lbl.pdf | |
| 02/19/2021 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s029lbl.pdf | |
| 11/18/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf | |
| 11/18/2020 | SUPPL-24 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf | |
| 11/18/2020 | SUPPL-23 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf | |
| 11/10/2020 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s012lbl.pdf | |
| 11/10/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s012lbl.pdf | |
| 06/05/2020 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf | |
| 06/05/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf | |
| 03/27/2020 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s018lbl.pdf | |
| 08/26/2019 | SUPPL-16 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761069Orig1s016lbl.pdf |
| 07/19/2019 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761069s013lbl.pdf | |
| 02/16/2018 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf | |
| 05/01/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf |