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New Drug Application (NDA): 208065
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGRISSO OSIMERTINIB MESYLATE EQ 40MG BASE TABLET;ORAL Prescription None Yes No
TAGRISSO OSIMERTINIB MESYLATE EQ 80MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208065Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2024 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s033ltr.pdf
04/29/2024 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s031ltr.pdf
02/16/2024 SUPPL-30 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s030ltr.pdf
01/31/2024 SUPPL-29 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s029ltr.pdf
06/21/2023 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208065Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208065Orig1s028ltr.pdf
10/21/2022 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208065Orig1s027ltr.pdf
09/30/2022 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208065Orig1s026ltr.pdf
01/19/2022 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208065Orig1s025ltr.pdf
07/26/2021 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208065s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208065Orig1s022ltr_.pdf
12/18/2020 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208065Orig1s021ltr.pdf
12/11/2020 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208065Orig1s019ltr.pdf
12/09/2020 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208065Orig1s018ltr.pdf
05/23/2020 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208065Orig1s016ltr.pdf
12/19/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208065s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208065Orig1s013ltr.pdf
08/28/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s011ltr.pdf
04/18/2018 SUPPL-9 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s009ltr.pdf
04/18/2018 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s008ltr.pdf
10/31/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208065Orig1s007ltr.pdf
03/30/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208065Orig1s006ltr.pdf
09/28/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s003ltr.pdf
08/12/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s002ltr.pdf
02/10/2016 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2024 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf
04/29/2024 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s031lbl.pdf
02/16/2024 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s030lbl.pdf
01/31/2024 SUPPL-29 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s029lbl.pdf
06/21/2023 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208065Orig1s028lbl.pdf
10/21/2022 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s027lbl.pdf
09/30/2022 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s026lbl.pdf
01/19/2022 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s025lbl.pdf
07/26/2021 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208065s022lbl.pdf
12/18/2020 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf
12/11/2020 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s019lbl.pdf
12/09/2020 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s018lbl.pdf
05/23/2020 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s016lbl.pdf
12/19/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208065s013lbl.pdf
08/28/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s011lbl.pdf
04/18/2018 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf
10/31/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s007lbl.pdf
03/30/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf
09/28/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf
08/12/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf
11/13/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf
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