Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202293
Company: ASTRAZENECA AB
Company: ASTRAZENECA AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FARXIGA | DAPAGLIFLOZIN | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| FARXIGA | DAPAGLIFLOZIN | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/08/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2024 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202293Orig1s031,205649Orig1s022ltr.pdf | |
| 09/12/2023 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s030;205649Orig1s021ltr.pdf | |
| 10/13/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202293Orig1s028,205649Orig1s018ltr.pdf | |
| 02/17/2023 | SUPPL-27 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s027ltr.pdf | |
| 05/08/2023 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf | |
| 04/30/2021 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202293Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s024TOC.cfm | |
| 02/03/2020 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s022, 205649Orig1s014ltr.pdf | |
| 01/24/2020 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s021, 205649Orig1s013, 209091Orig1s005, 210874Orig1s003ltr.pdf | |
| 05/05/2020 | SUPPL-20 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s020.pdf | |
| 10/18/2019 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s018, 205649Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s018.pdf | |
| 10/26/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf | |
| 02/22/2019 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s015, 205649Orig1s009ltr.pdf | |
| 10/20/2017 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s012ltr.pdf | |
| 03/01/2017 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s011ltr.pdf | |
| 08/17/2016 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s010ltr.pdf | |
| 06/14/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf | |
| 12/04/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf | |
| 01/06/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2014 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf | |
| 03/11/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf | |
| 07/31/2014 | 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 |
|---|---|---|---|---|---|
| 06/12/2024 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf | |
| 09/12/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf | |
| 05/08/2023 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf | |
| 02/17/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf | |
| 02/17/2023 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf | |
| 10/13/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293s028lbl.pdf | |
| 04/30/2021 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf | |
| 05/05/2020 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf | |
| 02/03/2020 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf | |
| 02/03/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf | |
| 01/24/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf | |
| 10/18/2019 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf | |
| 02/22/2019 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf | |
| 10/26/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf | |
| 10/20/2017 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf | |
| 03/01/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf | |
| 03/01/2017 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf | |
| 08/17/2016 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf | |
| 08/17/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf | |
| 06/14/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf | |
| 12/04/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf | |
| 03/11/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf | |
| 08/08/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf | |
| 01/08/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf |