Onglyza

NDA 22350, held by Astrazeneca AB. Saxagliptin Hydrochloride.

As of Nov 14, 2026, NDA 22350 (Onglyza), held by Astrazeneca AB, was first approved by FDA on Jul 31, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2009
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Oct 11, 2024	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter Medication Guide
Feb 27, 2017	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 5, 2016	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 24, 2013	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 16, 2011	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 18, 2011	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 18, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 31, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


OnglyzaEQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Saxagliptin Hydrochloride	DiscontinuedReference drug
OnglyzaEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Saxagliptin Hydrochloride	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Oct 11, 2024	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter Medication Guide
Jul 1, 2019	Supplement 23Labeling	Approved	Label Letter
Feb 27, 2017	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 18, 2017	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 5, 2016	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 25, 2015	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 28, 2015	Supplement 16Labeling	Approved	Label Letter
Jan 23, 2014	Supplement 13Manufacturing · Standard review	Approved	None posted
May 24, 2013	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 13, 2012	Supplement 9Labeling	Approved	Letter
Dec 16, 2011	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 15, 2011	Supplement 7Labeling	Approved	Letter Label
Feb 18, 2011	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 18, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 31, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22350
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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