← FDA DRUG APPROVALS

FDA NDA · NDA205879

INVOKAMET XR

canagliflozin and metformin hydrochloride

Sponsor: JANSSEN PHARMS

APPLICATION
NDA205879
TYPE
NDA
ORIGINAL APPROVAL
2016-09-20
LATEST ACTION
2024-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

INVOKAMET XR · ReferencePrescription
CANAGLIFLOZIN 150MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
INVOKAMET XR · ReferencePrescription
CANAGLIFLOZIN 50MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
INVOKAMET XR · ReferencePrescription
CANAGLIFLOZIN 150MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
INVOKAMET XR · ReferencePrescription
CANAGLIFLOZIN 50MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-12-18Efficacy · Supplement 23 · priority — Medication Guide ↗AP
2024-08-23Labeling · Supplement 22 · standard — Label ↗AP
2024-01-19Labeling · Supplement 20 · standard — Label ↗AP
2023-07-05Labeling · Supplement 19 · standard — Label ↗AP
2022-10-13Labeling · Supplement 18 · 901 required — Letter ↗AP
2020-08-18Efficacy · Supplement 17 · standard — Letter ↗AP
2020-01-27Efficacy · Supplement 11 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 14 · 901 required — Label ↗AP
2018-10-29Efficacy · Supplement 7 · standard — Label ↗AP
2018-10-26Labeling · Supplement 9 · 901 required — Letter ↗AP
2018-01-02Efficacy · Supplement 2 · standard — Label ↗AP
2017-08-11Labeling · Supplement 6 · standard — Label ↗AP
2017-07-25Labeling · Supplement 5 · 901 required — Label ↗AP
2016-09-20Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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