Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206073
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN | 10MG;5MG | TABLET;ORAL | Prescription | None | Yes | No |
| GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN | 25MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/2015 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2023 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028; 212614Orig1s020ltr.pdf | |
| 10/13/2022 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf | |
| 03/21/2022 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf | |
| 06/11/2021 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.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-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf | |
| 07/01/2019 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022, 208026Orig1s013ltr.pdf | |
| 03/30/2020 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201280Orig1s020, 201281Orig1s024, 206073Orig1s021, 208026Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/206073Orig1s021.pdf | |
| 10/26/2018 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf | |
| 07/03/2019 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017, 208026Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/206073Orig1s017.pdf | |
| 08/10/2017 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf | |
| 12/13/2017 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s012ltr.pdf | |
| 08/10/2017 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s011ltr.pdf | |
| 12/23/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf | |
| 03/14/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf | |
| 12/23/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf | |
| 07/08/2016 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf |
| 12/04/2015 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s003ltr.pdf | |
| 08/28/2015 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/30/2023 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf | |
| 10/13/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.pdf | |
| 03/21/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s031lbl.pdf | |
| 06/11/2021 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf | |
| 06/11/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf | |
| 03/30/2020 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf | |
| 01/24/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf | |
| 07/03/2019 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s017lbl.pdf | |
| 07/01/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf | |
| 07/01/2019 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf | |
| 10/26/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf | |
| 10/26/2018 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf | |
| 12/13/2017 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf | |
| 08/10/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s013lbl.pdf | |
| 08/10/2017 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s011lbl.pdf | |
| 03/14/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s008lbl.pdf | |
| 12/23/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf | |
| 12/23/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf | |
| 12/04/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf | |
| 08/28/2015 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf | |
| 01/30/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s000lbl.pdf |