← FDA DRUG APPROVALS

FDA NDA · NDA022350

ONGLYZA

Sponsor: ASTRAZENECA AB

APPLICATION
NDA022350
TYPE
NDA
ORIGINAL APPROVAL
2009-07-31
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ONGLYZA · ReferenceDiscontinued
SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ONGLYZA · ReferenceDiscontinued
SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-10-11Efficacy · Supplement 26 · standard — Label ↗AP
2019-07-01Labeling · Supplement 23 · 901 required — Letter ↗AP
2017-02-27Efficacy · Supplement 18 · standard — Label ↗AP
2017-01-18Labeling · Supplement 19 · standard — Label ↗AP
2016-04-05Efficacy · Supplement 14 · standard — Label ↗AP
2015-11-25Manufacturing (CMC) · Supplement 17 · standardAP
2015-08-28Labeling · Supplement 16 · 901 required — Label ↗AP
2014-01-23Manufacturing (CMC) · Supplement 13 · standardAP
2013-05-24Efficacy · Supplement 11 · standard — Letter ↗AP
2012-03-13Labeling · Supplement 9 · unknown — Letter ↗AP
2011-12-16Efficacy · Supplement 4 · standard — Label ↗AP
2011-11-15Labeling · Supplement 7 · unknown — Label ↗AP
2011-02-18Efficacy · Supplement 2 · standard — Letter ↗AP
2011-02-18Efficacy · Supplement 1 · standard — Label ↗AP
2009-07-31Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →