Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204629
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JARDIANCE EMPAGLIFLOZIN 10MG TABLET;ORAL Prescription None Yes No
JARDIANCE EMPAGLIFLOZIN 25MG 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
08/01/2014 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/2014/204629s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s019Ltr.pdf
10/26/2018 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf
12/13/2017 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204629Orig1s016ltr.pdf
07/08/2016 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf
04/15/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/21/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/12/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/02/2016 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s008ltr.pdf
12/04/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf
03/18/2016 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf
02/05/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf
06/26/2015 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf
06/26/2015 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf
06/26/2015 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf
10/26/2018 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf
10/26/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf
12/13/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf
12/13/2017 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf
12/02/2016 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf
03/18/2016 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf
02/05/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf
12/04/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf
06/26/2015 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf
06/26/2015 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf
06/26/2015 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf
08/01/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf

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