U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761069
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
04/22/2024 SUPPL-48 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761069Orig1s048ltr.pdf
07/24/2024 SUPPL-47 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761069Orig1s047ltr.pdf
06/14/2024 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761069Orig1s045ltr.pdf
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
08/15/2024 SUPPL-43 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761069Orig1s043ltr.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
08/15/2024 SUPPL-43 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf
07/24/2024 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s047lbl.pdf
06/14/2024 SUPPL-45 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s045lbl.pdf
04/22/2024 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s048lbl.pdf
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf
06/05/2020 SUPPL-20 Labeling-Medication Guide 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
Back to Top