← FDA DRUG APPROVALS

FDA NDA · NDA202293

FARXIGA

dapagliflozin

Sponsor: ASTRAZENECA AB

APPLICATION
NDA202293
TYPE
NDA
ORIGINAL APPROVAL
2014-01-08
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FARXIGA · ReferencePrescription
DAPAGLIFLOZIN 10MG · TABLET · ORAL
FARXIGA · ReferencePrescription
DAPAGLIFLOZIN 5MG · TABLET · ORAL

Approval history

2026-06-03Labeling · Supplement 35 · standard — Letter ↗AP
2024-06-12Efficacy · Supplement 31 · priority — Letter ↗AP
2023-09-12Labeling · Supplement 30 · standard — Letter ↗AP
2023-05-08Efficacy · Supplement 26 · standard — Label ↗AP
2023-02-17Labeling · Supplement 27 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 28 · 901 required — Letter ↗AP
2021-04-30Efficacy · Supplement 24 · priority — Label ↗AP
2020-05-05Efficacy · Supplement 20 · priority — Label ↗AP
2020-02-03Labeling · Supplement 22 · standard — Label ↗AP
2020-01-24Labeling · Supplement 21 · 901 required — Label ↗AP
2019-10-18Efficacy · Supplement 18 · standard — Label ↗AP
2019-02-22Efficacy · Supplement 15 · standard — Label ↗AP
2018-10-26Labeling · Supplement 17 · standard — Letter ↗AP
2017-10-20Efficacy · Supplement 12 · standard — Letter ↗AP
2017-03-01Labeling · Supplement 11 · standard — Label ↗AP
2016-08-17Labeling · Supplement 10 · standard — Letter ↗AP
2016-06-14Labeling · Supplement 9 · standard — Label ↗AP
2016-01-12Manufacturing (CMC) · Supplement 6 · standardAP
2016-01-06Manufacturing (CMC) · Supplement 7 · standardAP
2015-12-04Labeling · Supplement 8 · 901 required — Label ↗AP
2015-03-11Efficacy · Supplement 2 · standard — Letter ↗AP
2014-08-08Labeling · Supplement 3 · standard — Letter ↗AP
2014-07-31Manufacturing (CMC) · Supplement 1 · standardAP
2014-01-08Type 1 - New Molecular Entity · Original · standard — Label ↗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 →