Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209805
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 5MG;EQ 100MG BASE TABLET;ORAL Prescription None Yes No
STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 15MG;EQ 100MG BASE 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
12/19/2017 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209805Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209805Orig1s005ltr.pdf
10/26/2018 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209805Orig1s004Ltr.pdf
03/06/2018 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209805Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/01/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf
10/26/2018 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf
10/26/2018 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf
03/06/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf
12/19/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf

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