Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208658
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 25MG;1GM | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/09/2016 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208658Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/30/2023 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028; 212614Orig1s020ltr.pdf | |
06/20/2023 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s038,s039;208658Orig1s025,s026ltr.pdf | |
06/20/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s038,s039;208658Orig1s025,s026ltr.pdf | |
10/13/2022 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf | |
02/06/2023 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208658s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s033,208658Orig1s021ltr.pdf | |
03/21/2022 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf | |
06/11/2021 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.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-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf | |
01/24/2020 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf | |
10/26/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf | |
12/13/2017 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf | |
12/23/2016 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/30/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf | |
06/20/2023 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf | |
06/20/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf | |
02/06/2023 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208658s021lbl.pdf | |
10/13/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s023lbl.pdf | |
03/21/2022 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s017lbl.pdf | |
06/11/2021 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf | |
06/11/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf | |
01/24/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf | |
01/24/2020 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf | |
10/26/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf | |
10/26/2018 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf | |
12/13/2017 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf | |
12/23/2016 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s001lbl.pdf | |
12/09/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s000lbl.pdf |