Kazano

For type 2 diabetes mellitus. NDA 203414, held by Takeda Pharms USA. Alogliptin Benzoate; Metformin Hydrochloride.

As of Nov 14, 2026, NDA 203414 (Kazano), held by Takeda Pharms USA, was first approved by FDA on Jan 25, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2013
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Jul 27, 2023	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Apr 5, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 25, 2013	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


KazanoEQ 12.5MG BASE;500MG · tablet;oral	Alogliptin Benzoate; Metformin Hydrochloride	RxReference drug
KazanoEQ 12.5MG BASE;1GM · tablet;oral	Alogliptin Benzoate; Metformin Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 19Labeling	Approved	Label Letter
Jul 27, 2023	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Mar 11, 2022	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 1, 2019	Supplement 12Labeling	Approved	Label Letter
Feb 15, 2017	Supplement 7Labeling · Standard review	Approved	Label
Dec 12, 2016	Supplement 8Labeling	Approved	Label Letter
Dec 12, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Apr 5, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2015	Supplement 5Labeling	Approved	Label Letter
Aug 21, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 17, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 203414
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters