Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201280
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRADJENTA LINAGLIPTIN 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
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
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
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

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