← FDA DRUG APPROVALS

FDA NDA · NDA204042

INVOKANA

canagliflozin

Sponsor: JANSSEN PHARMS

APPLICATION
NDA204042
TYPE
NDA
ORIGINAL APPROVAL
2013-03-29
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

INVOKANA · ReferencePrescription
CANAGLIFLOZIN 300MG · TABLET · ORAL
INVOKANA · ReferencePrescription
CANAGLIFLOZIN 100MG · TABLET · ORAL

Approval history

2026-06-03Labeling · Supplement 44 · standard — Letter ↗AP
2024-12-18Efficacy · Supplement 43 · priority — Label ↗AP
2024-08-23Labeling · Supplement 41 · standard — Label ↗AP
2024-08-23Labeling · Supplement 42 · standard — Label ↗AP
2023-07-05Labeling · Supplement 40 · standard — Label ↗AP
2022-10-13Labeling · Supplement 39 · 901 required — Letter ↗AP
2020-08-18Efficacy · Supplement 34 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 36 · 901 required — Label ↗AP
2019-09-27Efficacy · Supplement 32 · priority — Letter ↗AP
2018-10-29Efficacy · Supplement 27 · standard — Label ↗AP
2018-10-26Labeling · Supplement 31 · 901 required — Letter ↗AP
2017-07-25Labeling · Supplement 26 · 901 required — Label ↗AP
2017-02-01Efficacy · Supplement 18 · standard — Letter ↗AP
2016-08-17Labeling · Supplement 22 · 901 required — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 16 · standardAP
2016-05-20Labeling · Supplement 19 · 901 required — Label ↗AP
2016-05-20Efficacy · Supplement 15 · standard — Label ↗AP
2016-03-28Labeling · Supplement 11 · standard — Label ↗AP
2016-03-08Manufacturing (CMC) · Supplement 12 · standardAP
2015-12-04Labeling · Supplement 13 · 901 required — Review ↗AP
2015-09-10Efficacy · Supplement 6 · standard — Label ↗AP
2015-09-09Manufacturing (CMC) · Supplement 9 · standardAP
2015-03-03Labeling · Supplement 5 · standard — Label ↗AP
2014-06-05Manufacturing (CMC) · Supplement 3 · standardAP
2014-05-15Labeling · Supplement 2 · standard — Label ↗AP
2013-11-26Manufacturing (CMC) · Supplement 1 · standardAP
2013-03-29Type 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 →