← FDA DRUG APPROVALS

FDA NDA · NDA203414

KAZANO

alogliptin and metformin hydrochloride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA203414
TYPE
NDA
ORIGINAL APPROVAL
2013-01-25
LATEST ACTION
2023-07-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KAZANO · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 12.5MG BASE, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
KAZANO · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 12.5MG BASE, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL

Approval history

2023-07-27Efficacy · Supplement 16 · standard — Label ↗AP
2022-03-11Labeling · Supplement 13 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 12 · 901 required — Letter ↗AP
2017-02-15Labeling · Supplement 7 · standard — Label ↗AP
2016-12-12Labeling · Supplement 8 · 901 required — Letter ↗AP
2016-12-12Labeling · Supplement 9 · standard — Letter ↗AP
2016-04-05Efficacy · Supplement 3 · standard — Label ↗AP
2015-08-28Labeling · Supplement 5 · 901 required — Letter ↗AP
2014-08-21Manufacturing (CMC) · Supplement 4 · standardAP
2013-10-17Manufacturing (CMC) · Supplement 1 · standardAP
2013-01-25Type 4 - New Combination · Original · standard — 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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