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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210874
Company: ASTRAZENECA AB

Medication Guide

Products on NDA 210874

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210874

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2019	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210874Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210874Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s021, 205649Orig1s013, 209091Orig1s005, 210874Orig1s003ltr.pdf
07/01/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004, 210874Orig1s001ltr.pdf

Labels for NDA 210874

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf
07/01/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf
05/02/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf

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