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New Drug Application (NDA): 209803
Company: MSD SUB MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STEGLATRO ERTUGLIFLOZIN 5MG TABLET;ORAL Prescription AB Yes No
STEGLATRO ERTUGLIFLOZIN 15MG 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
12/19/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209803Orig1s000ltr.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
09/12/2023 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209803Orig1s007;209805Orig1s016;209806Orig1s010ltr.pdf
10/13/2022 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209803Orig1s006,209805Orig1s012,209806Orig1s009ltr.pdf
09/17/2021 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209803Orig1s004; 209805Orig1s008; 209806Orig1s006ltr.pdf
01/24/2020 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf
10/26/2018 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209803Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/12/2023 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf
10/13/2022 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf
09/17/2021 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf
01/24/2020 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf
01/24/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf
10/26/2018 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf
10/26/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf
12/19/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf

STEGLATRO

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERTUGLIFLOZIN ERTUGLIFLOZIN 5MG TABLET;ORAL Prescription No AB 217071 HETERO LABS LTD V
STEGLATRO ERTUGLIFLOZIN 5MG TABLET;ORAL Prescription Yes AB 209803 MSD SUB MERCK

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERTUGLIFLOZIN ERTUGLIFLOZIN 15MG TABLET;ORAL Prescription No AB 217071 HETERO LABS LTD V
STEGLATRO ERTUGLIFLOZIN 15MG TABLET;ORAL Prescription Yes AB 209803 MSD SUB MERCK
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