Synjardy Xr

For type 2 diabetes mellitus. NDA 208658, held by Boehringer Ingelheim. Empagliflozin; Metformin Hydrochloride.

As of Nov 14, 2026, NDA 208658 (Synjardy Xr), held by Boehringer Ingelheim, was first approved by FDA on Dec 9, 2016, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 9, 2016
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, 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. SYNJARDY XR

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Mar 7, 2025	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 20, 2023	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 6, 2023	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 23, 2016	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 9, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

4 strengths and forms


Synjardy Xr5MG;1GM · tablet, extended release;oral	Empagliflozin; Metformin Hydrochloride	RxReference drug
Synjardy Xr10MG;1GM · tablet, extended release;oral	Empagliflozin; Metformin Hydrochloride	RxReference drug
Synjardy Xr12.5MG;1GM · tablet, extended release;oral	Empagliflozin; Metformin Hydrochloride	RxReference drug
Synjardy Xr25MG;1GM · tablet, extended release;oral	Empagliflozin; Metformin Hydrochloride	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 38Labeling	Approved	Label Medication Guide Letter
Oct 24, 2025	Supplement 34Labeling · Standard review	Approved	Letter Label
Mar 7, 2025	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 30, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
Jun 20, 2023	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 20, 2023	Supplement 25Labeling · Standard review	Approved	Label Letter
Feb 6, 2023	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 13, 2022	Supplement 23Labeling	Approved	Label Letter
Mar 21, 2022	Supplement 17Labeling · Standard review	Approved	Label Letter
Jun 11, 2021	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 11, 2021	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 24, 2020	Supplement 9Labeling	Approved	Label Letter
Oct 26, 2018	Supplement 6Labeling	Approved	Letter Label
Dec 13, 2017	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 23, 2016	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 9, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 208658
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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