Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201281
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | AB | Yes | No |
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | AB | Yes | No |
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;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 |
|---|---|---|---|---|---|---|---|
| 01/30/2012 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281_linagliptin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/20/2023 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201281Orig1s035;208026Orig1s024ltr.pdf | |
| 04/15/2022 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201280Orig1s025; 201281Orig1s031ltr.pdf | |
| 07/01/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022, 208026Orig1s013ltr.pdf | |
| 03/30/2020 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201280Orig1s020, 201281Orig1s024, 206073Orig1s021, 208026Orig1s012ltr.pdf | |
| 07/03/2019 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017, 208026Orig1s008ltr.pdf | |
| 08/10/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf | |
| 12/23/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf | |
| 03/14/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf | |
| 12/23/2016 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf | |
| 04/29/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2015 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf | |
| 09/18/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf | |
| 05/22/2014 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf | |
| 07/30/2014 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201281Orig1s006ltr.pdf | |
| 12/18/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s004ltr.pdf | |
| 06/18/2013 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s003ltr.pdf | |
| 09/25/2012 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/20/2023 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf | |
| 04/15/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf | |
| 03/30/2020 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.pdf | |
| 07/03/2019 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s022lbl.pdf | |
| 07/01/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s025lbl.pdf | |
| 08/10/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf | |
| 03/14/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf | |
| 12/23/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf | |
| 12/23/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf | |
| 08/28/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf | |
| 07/28/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf | |
| 07/30/2014 | SUPPL-6 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf | |
| 05/22/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf | |
| 09/05/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf | |
| 06/18/2013 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf | |
| 01/30/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf |
JENTADUETO
TABLET;ORAL; 2.5MG;500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |
TABLET;ORAL; 2.5MG;850MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;850MG | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |
TABLET;ORAL; 2.5MG;1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET;ORAL | Prescription | Yes | AB | 201281 | BOEHRINGER INGELHEIM |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET;ORAL | Prescription | No | AB | 208336 | SUNSHINE |