Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206111
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET;ORAL | Prescription | AB | Yes | No |
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;500MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;1GM | 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 |
|---|---|---|---|---|---|---|---|
| 08/26/2015 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206111Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2023 | SUPPL-42 | 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-39 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf | |
| 06/20/2023 | SUPPL-38 | Efficacy-New Patient Population |
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-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf | |
| 02/06/2023 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s033,208658Orig1s021ltr.pdf | |
| 03/21/2022 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf | |
| 06/11/2021 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.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-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf | |
| 01/24/2020 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf | |
| 12/13/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf | |
| 07/08/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf | |
| 05/06/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2016 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf | |
| 12/23/2016 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s004ltr.pdf | |
| 12/04/2015 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s002ltr.pdf | |
| 07/08/2016 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/30/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf | |
| 06/20/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf | |
| 06/20/2023 | SUPPL-38 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf | |
| 02/06/2023 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s033lbl.pdf | |
| 10/13/2022 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s036lbl.pdf | |
| 03/21/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s031lbl.pdf | |
| 06/11/2021 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf | |
| 06/11/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf | |
| 01/24/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.pdf | |
| 01/24/2020 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf | |
| 10/26/2018 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf | |
| 12/13/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf | |
| 12/23/2016 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf | |
| 07/08/2016 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf | |
| 07/08/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf | |
| 07/08/2016 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf | |
| 07/08/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf | |
| 07/08/2016 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf | |
| 12/04/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf | |
| 08/26/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf |
SYNJARDY
TABLET;ORAL; 5MG;500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | Prescription | Yes | AB | 206111 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 5MG;1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET;ORAL | Prescription | Yes | AB | 206111 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 12.5MG;500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;500MG | TABLET;ORAL | Prescription | Yes | AB | 206111 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 12.5MG;1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;1GM | TABLET;ORAL | Prescription | Yes | AB | 206111 | BOEHRINGER INGELHEIM |