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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209806
Company: MSD SUB MERCK

Medication Guide

Products on NDA 209806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	None	Yes	No
SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET;ORAL	Prescription	None	Yes	No
SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;500MG	TABLET;ORAL	Prescription	None	Yes	No
SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;1GM	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209806

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/2017/209806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209806Orig1s000ltr.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-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209806s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209803Orig1s007;209805Orig1s016;209806Orig1s010ltr.pdf
10/13/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209803Orig1s006,209805Orig1s012,209806Orig1s009ltr.pdf
03/02/2022	SUPPL-8	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209805Orig1s010, 209806Orig1s008ltr.pdf
09/17/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209806s006lbl.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/2020/209806s002lbl.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/2018/209806s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209806Orig1s001Ltr.pdf

Labels for NDA 209806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209806s010lbl.pdf
09/12/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209806s010lbl.pdf
10/13/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s009lbl.pdf
03/02/2022	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s008lbl.pdf
09/17/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209806s006lbl.pdf
01/24/2020	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209806s002lbl.pdf
01/24/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209806s002lbl.pdf
10/26/2018	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209806s001lbl.pdf
10/26/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209806s001lbl.pdf
12/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209806s000lbl.pdf

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