← FDA DRUG APPROVALS

FDA NDA · NDA022426

ALOGLIPTIN AND PIOGLITAZONE

alogliptin benzoate and pioglitazone hydrochloride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022426
TYPE
NDA
ORIGINAL APPROVAL
2013-01-25
LATEST ACTION
2024-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

OSENI · ReferenceDiscontinued
ALOGLIPTIN BENZOATE EQ 12.5MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
OSENI · ReferenceDiscontinued
ALOGLIPTIN BENZOATE EQ 12.5MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
OSENI · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 25MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
OSENI · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 12.5MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
OSENI · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 25MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE · TABLET · ORAL
OSENI · ReferencePrescription
ALOGLIPTIN BENZOATE EQ 25MG BASE, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL

Approval history

2024-06-28Labeling · Supplement 16 · standard — Label ↗AP
2022-03-11Labeling · Supplement 14 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 12 · 901 required — Letter ↗AP
2017-12-21Labeling · Supplement 10 · standard — Label ↗AP
2016-12-12Labeling · Supplement 9 · standard — Letter ↗AP
2016-12-12Efficacy · Supplement 6 · standard — Letter ↗AP
2016-04-05Efficacy · Supplement 3 · standard — Label ↗AP
2016-03-17Manufacturing (CMC) · Supplement 4 · standardAP
2015-08-28Labeling · Supplement 5 · 901 required — Label ↗AP
2013-08-15Manufacturing (CMC) · Supplement 1 · standardAP
2013-01-25Type 4 - New Combination · Original · standard — Other ↗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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