Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206111
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 None Yes No
SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET;ORAL Prescription None Yes No
SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;500MG TABLET;ORAL Prescription None Yes No
SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;1GM 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
08/26/2015 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
10/26/2018 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
10/26/2018 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

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