Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201280
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRADJENTA | LINAGLIPTIN | 5MG | 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 |
---|---|---|---|---|---|---|---|
05/02/2011 | 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/2011/201280lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201280s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/20/2023 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201280Orig1s027ltr.pdf | |
04/15/2022 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201280Orig1s025; 201281Orig1s031ltr.pdf | |
07/01/2019 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022, 208026Orig1s013ltr.pdf | |
03/30/2020 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201280s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201280Orig1s020, 201281Orig1s024, 206073Orig1s021, 208026Orig1s012ltr.pdf | |
07/03/2019 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017, 208026Orig1s008ltr.pdf | |
08/10/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf | |
12/23/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201280Orig1s015,208026Orig1s004ltr.pdf | |
03/14/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf | |
12/20/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/28/2015 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf | |
07/28/2015 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf | |
07/20/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf | |
06/18/2013 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201280Orig1s006ltr.pdf | |
09/28/2012 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s005ltr.pdf | |
08/13/2012 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf | |
08/13/2012 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf | |
05/22/2012 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201280Orig1s002.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/20/2023 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf | |
04/15/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf | |
03/30/2020 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201280s020lbl.pdf | |
07/03/2019 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s018lbl.pdf | |
07/01/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s021lbl.pdf | |
08/10/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s016lbl.pdf | |
03/14/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf | |
12/23/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf | |
08/28/2015 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf | |
07/28/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf | |
05/22/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf | |
06/18/2013 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf | |
09/28/2012 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf | |
08/13/2012 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf | |
08/13/2012 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf | |
05/22/2012 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf | |
05/02/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201280lbl.pdf |
TRADJENTA
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LINAGLIPTIN | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | No | AB | 208423 | INVAGEN PHARMS |
LINAGLIPTIN | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | No | AB | 208335 | SUNSHINE |
TRADJENTA | LINAGLIPTIN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 201280 | BOEHRINGER INGELHEIM |