Xigduo Xr

For type 2 diabetes mellitus. NDA 205649, held by Astrazeneca AB. Dapagliflozin; Metformin Hydrochloride.

As of Nov 15, 2026, NDA 205649 (Xigduo Xr), held by Astrazeneca AB, was first approved by FDA on Oct 29, 2014, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2014
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:

Sustained eGFR decline, end‑stage kidney disease, (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.
CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 20, 2024	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 12, 2024	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 11, 2022	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 3, 2022	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 22, 2019	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 29, 2014	Original applicationNew combination · Standard review	Approved	Summary Review Review Label Letter

Products

5 strengths and forms


Xigduo Xr5MG;500MG · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride	RxReference drug
Xigduo Xr5MG;1GM · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride	RxReference drug
Xigduo Xr10MG;500MG · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride	RxReference drug
Xigduo Xr10MG;1GM · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride	RxReference drug
Xigduo Xr2.5MG;1GM · tablet, extended release;oral	Dapagliflozin; Metformin Hydrochloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 28Labeling · Standard review	Approved	Label Letter
Aug 11, 2026	Supplement 29Labeling	Approved	Label Medication Guide Letter
Dec 20, 2024	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 12, 2024	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 12, 2023	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 13, 2022	Supplement 18Labeling	Approved	Label Letter
Apr 11, 2022	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 3, 2022	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 3, 2020	Supplement 14Labeling · Standard review	Approved	Label Letter
Jan 24, 2020	Supplement 13Labeling	Approved	Label Letter
Oct 18, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 12, 2019	Supplement 12Manufacturing	Tentative approval	Letter
Feb 22, 2019	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 10Labeling · Standard review	Approved	Label Letter
Jul 28, 2017	Supplement 8Manufacturing	Approved	Label
Mar 1, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 10, 2017	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 17, 2016	Supplement 5Labeling · Standard review	Approved	Label Letter
Jun 14, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Jan 12, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 4, 2015	Supplement 3Labeling	Approved	Label Letter
Sep 1, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 29, 2014	Original applicationNew combination · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 205649
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