← FDA DRUG APPROVALS

FDA NDA · NDA204353

INVOKAMET

canagliflozin and metformin hydrochloride

Sponsor: JANSSEN PHARMS

APPLICATION
NDA204353
TYPE
NDA
ORIGINAL APPROVAL
2014-08-08
LATEST ACTION
2024-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-12-18Efficacy · Supplement 46 · priority — Label ↗AP
2024-08-23Labeling · Supplement 45 · standard — Label ↗AP
2024-01-19Labeling · Supplement 43 · standard — Label ↗AP
2023-07-05Labeling · Supplement 42 · standard — Label ↗AP
2022-10-13Labeling · Supplement 41 · 901 required — Letter ↗AP
2020-08-18Efficacy · Supplement 39 · standard — Letter ↗AP
2020-01-27Efficacy · Supplement 33 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 36 · 901 required — Label ↗AP
2018-10-29Efficacy · Supplement 25 · standard — Label ↗AP
2018-10-26Labeling · Supplement 31 · 901 required — Letter ↗AP
2017-08-11Labeling · Supplement 24 · standard — Label ↗AP
2017-07-25Labeling · Supplement 23 · 901 required — Label ↗AP
2017-02-01Efficacy · Supplement 14 · standard — Letter ↗AP
2016-11-23Manufacturing (CMC) · Supplement 19 · standardAP
2016-08-17Labeling · Supplement 20 · 901 required — Letter ↗AP
2016-05-20Labeling · Supplement 15 · 901 required — Label ↗AP
2016-05-20Efficacy · Supplement 6 · standard — Label ↗AP
2016-04-14Manufacturing (CMC) · Supplement 11 · standardAP
2016-03-28Labeling · Supplement 10 · standard — Letter ↗AP
2016-03-17Manufacturing (CMC) · Supplement 8 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 7 · standardAP
2015-12-04Labeling · Supplement 12 · 901 required — Label ↗AP
2015-09-10Efficacy · Supplement 3 · standard — Label ↗AP
2015-06-08Manufacturing (CMC) · Supplement 4 · standardAP
2015-03-03Labeling · Supplement 2 · standard — Label ↗AP
2014-08-08Type 4 - New Combination · Original · standard — Summary Review ↗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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