Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208065
Company: ASTRAZENECA
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 |