Orange Book product · Brand (NDA)

ONGLYZA

SAXAGLIPTIN HYDROCHLORIDE

Brand (NDA)NDA 022350DISCN ASTRAZENECA AB

Jul 31, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 31, 2009
17 yr 2 mo ago
Today
Patent 7951400 expires
Listed drug product patent expiration.
Nov 30, 2028
in 2 yr 6 mo

Active ingredient

SAXAGLIPTIN HYDROCHLORIDE

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022350

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7951400	Nov 30, 2028	in 2 yr 6 mo	Product