Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204629
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JARDIANCE | EMPAGLIFLOZIN | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| JARDIANCE | EMPAGLIFLOZIN | 25MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/01/2014 | 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/2014/204629s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/20/2023 | SUPPL-42 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s042ltr.pdf | |
| 09/12/2023 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s041ltr.pdf | |
| 09/21/2023 | SUPPL-40 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s040ltr.pdf | |
| 10/13/2022 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf | |
| 03/21/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf | |
| 02/24/2022 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/204629Orig1s033.pdf | |
| 06/11/2021 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, s029; 206073Orig1s027, s030; 206111Orig1s025, s026; 208658Orig1s013, s015; 212614Orig1s008, s010ltr.pdf | |
| 06/11/2021 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf | |
| 08/18/2021 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s026ltr.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf | |
| 12/21/2018 | SUPPL-19 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s019Ltr.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf | |
| 12/13/2017 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204629Orig1s016ltr.pdf | |
| 07/08/2016 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf |
| 04/15/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/2016 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s008.pdf | |
| 12/04/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s007.pdf | |
| 03/18/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s005.pdf | |
| 02/05/2016 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf | |
| 06/26/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s003.pdf | |
| 06/26/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s002.pdf | |
| 06/26/2015 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2023 | SUPPL-40 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf | |
| 09/12/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s041lbl.pdf | |
| 06/20/2023 | SUPPL-42 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf | |
| 10/13/2022 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf | |
| 03/21/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf | |
| 02/24/2022 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf | |
| 08/18/2021 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf | |
| 06/11/2021 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf | |
| 06/11/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf | |
| 12/21/2018 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf | |
| 12/13/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf | |
| 12/13/2017 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf | |
| 12/02/2016 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf | |
| 03/18/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf | |
| 02/05/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf | |
| 12/04/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf | |
| 06/26/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf | |
| 06/26/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf | |
| 06/26/2015 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf | |
| 08/01/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf |
JARDIANCE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JARDIANCE | EMPAGLIFLOZIN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 204629 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JARDIANCE | EMPAGLIFLOZIN | 25MG | TABLET;ORAL | Prescription | Yes | AB | 204629 | BOEHRINGER INGELHEIM |