Qternmet Xr

NDA 210874, held by Astrazeneca AB. Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride.

As of Nov 14, 2026, NDA 210874 (Qternmet Xr), held by Astrazeneca AB, was first approved by FDA on May 2, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: May 2, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 2, 2019	Original applicationNew combination · Standard review	Approved	Review Label Medication Guide Letter

Products

4 strengths and forms


Qternmet Xr2.5MG;1GM;EQ 2.5MG BASE · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride	DiscontinuedReference drug
Qternmet Xr5MG;1GM;EQ 2.5MG BASE · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride	DiscontinuedReference drug
Qternmet Xr5MG;1GM;EQ 5MG BASE · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride	DiscontinuedReference drug
Qternmet Xr10MG;1GM;EQ 5MG BASE · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jan 24, 2020	Supplement 3Labeling	Approved	Label Medication Guide Letter
Jul 1, 2019	Supplement 1Labeling	Approved	Label Medication Guide Letter
May 2, 2019	Original applicationNew combination · Standard review	Approved	Review Label Medication Guide Letter

Identifiers

Application: NDA 210874
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters