Jardiance

Lowers the risk of cardiovascular death and hospitalization for heart failure. NDA 204629, held by Boehringer Ingelheim. Empagliflozin.

As of Nov 13, 2026, NDA 204629 (Jardiance), held by Boehringer Ingelheim, was first approved by FDA on Aug 1, 2014, with 25 approved supplements and 0 published complete response letters.

First approved: Aug 1, 2014
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


Sep 21, 2023	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 20, 2023	Supplement 42Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 24, 2022	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 18, 2021	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2016	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 18, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 26, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 26, 2015	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 26, 2015	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 1, 2014	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Label Letter

Products

2 strengths and forms


Jardiance10MG · tablet;oral	Empagliflozin	RxReference drug
Jardiance25MG · tablet;oral	Empagliflozin	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Oct 24, 2025	Supplement 63Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 21, 2023	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 12, 2023	Supplement 41Labeling · Standard review	Approved	Letter Label
Jun 20, 2023	Supplement 42Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 13, 2022	Supplement 39Labeling	Approved	Label Letter
Mar 21, 2022	Supplement 34Labeling · Standard review	Approved	Label Letter
Feb 24, 2022	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 18, 2021	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 11, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 11, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Jan 24, 2020	Supplement 23Labeling	Approved	Label Letter
Dec 21, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 18Labeling	Approved	Letter Label
Dec 13, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 2, 2016	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jul 8, 2016	Supplement 12Labeling · Standard review	Approved	Letter
Apr 15, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 18, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 5, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Jan 21, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 12, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 4, 2015	Supplement 7Labeling	Approved	Review Label Letter
Jun 26, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 26, 2015	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 26, 2015	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 1, 2014	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Identifiers

Application: NDA 204629
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