← FDA DRUG APPROVALS

FDA NDA · NDA204629

JARDIANCE

empagliflozin

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA204629
TYPE
NDA
ORIGINAL APPROVAL
2014-08-01
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JARDIANCE · ReferencePrescription
EMPAGLIFLOZIN 25MG · TABLET · ORAL
JARDIANCE · ReferencePrescription
EMPAGLIFLOZIN 10MG · TABLET · ORAL

Approval history

2025-10-24Labeling · Supplement 63 · standard — Label ↗AP
2023-09-21Efficacy · Supplement 40 · standard — Letter ↗AP
2023-09-12Labeling · Supplement 41 · standard — Letter ↗AP
2023-06-20Efficacy · Supplement 42 · priority — Letter ↗AP
2022-10-13Labeling · Supplement 39 · 901 required — Letter ↗AP
2022-03-21Labeling · Supplement 34 · standard — Letter ↗AP
2022-02-24Efficacy · Supplement 33 · priority — Letter ↗AP
2021-08-18Efficacy · Supplement 26 · standard — Letter ↗AP
2021-06-11Labeling · Supplement 28 · standard — Label ↗AP
2021-06-11Labeling · Supplement 29 · standard — Label ↗AP
2020-01-24Labeling · Supplement 23 · 901 required — Label ↗AP
2018-12-21Labeling · Supplement 19 · standard — Label ↗AP
2018-10-26Labeling · Supplement 18 · 901 required — Label ↗AP
2017-12-13Labeling · Supplement 16 · standard — Label ↗AP
2016-12-02Efficacy · Supplement 8 · standard — Label ↗AP
2016-07-08Labeling · Supplement 12 · standard — Letter ↗AP
2016-04-15Manufacturing (CMC) · Supplement 11 · standardAP
2016-03-18Efficacy · Supplement 5 · standard — Review ↗AP
2016-02-05Labeling · Supplement 4 · standard — Label ↗AP
2016-01-21Manufacturing (CMC) · Supplement 10 · standardAP
2016-01-12Manufacturing (CMC) · Supplement 9 · standardAP
2015-12-04Labeling · Supplement 7 · 901 required — Review ↗AP
2015-06-26Efficacy · Supplement 2 · standard — Label ↗AP
2015-06-26Efficacy · Supplement 3 · standard — Label ↗AP
2015-06-26Efficacy · Supplement 1 · standard — Review ↗AP
2014-08-01Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →