Documents
Application Sponsors
| BLA 761069 | ASTRAZENECA UK LTD | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 50MG/ML | 2 | IMFINZI | DURVALUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-05-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2018-02-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-11-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2019-07-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2019-08-26 | N/A |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2020-03-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-06-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2020-11-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2020-11-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2020-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-07-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2021-02-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2022-05-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2022-11-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2022-09-02 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2022-10-21 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 6 |
CDER Filings
ASTRAZENECA UK LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 761069
[companyName] => ASTRAZENECA UK LTD
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761069s020lbl.pdf#page=30"]
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[actionDate] => 2020-06-05
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