Glyxambi

For type 2 diabetes mellitus. NDA 206073, held by Boehringer Ingelheim. Empagliflozin; Linagliptin.

As of Nov 14, 2026, NDA 206073 (Glyxambi), held by Boehringer Ingelheim, was first approved by FDA on Jan 30, 2015, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 30, 2015
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Mar 30, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jul 3, 2019	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 23, 2016	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 30, 2015	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Glyxambi10MG;5MG · tablet;oral	Empagliflozin; Linagliptin	RxReference drug
Glyxambi25MG;5MG · tablet;oral	Empagliflozin; Linagliptin	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Oct 24, 2025	Supplement 44Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 30, 2023	Supplement 36Labeling · Standard review	Approved	Label Letter
Oct 13, 2022	Supplement 33Labeling	Approved	Label Letter
Mar 21, 2022	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 11, 2021	Supplement 30Labeling · Standard review	Approved	Letter Label
Jun 11, 2021	Supplement 27Labeling · Standard review	Approved	Letter Label
Mar 30, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 24, 2020	Supplement 23Labeling	Approved	Label Letter
Jul 3, 2019	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 1, 2019	Supplement 22Labeling · Standard review	Approved	Label Letter
Oct 26, 2018	Supplement 19Labeling	Approved	Letter Label
Dec 13, 2017	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 10, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 10, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 14, 2017	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 23, 2016	Supplement 9Labeling	Approved	Label Letter
Dec 23, 2016	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 8, 2016	Supplement 6Labeling · Standard review	Approved	Letter
Dec 4, 2015	Supplement 3Labeling	Approved	Label Letter
Aug 28, 2015	Supplement 1Labeling	Approved	Label Letter
Jan 30, 2015	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 206073
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