Details for New Drug Application (NDA): 022350

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NDA 022350 describes ONGLYZA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ONGLYZA profile page.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

Summary for 022350

Tradename:	ONGLYZA
Applicant:	Astrazeneca Ab
Ingredient:	saxagliptin hydrochloride
Patents:	1

Pharmacology for NDA: 022350

Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 022350

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350	NDA	AstraZeneca Pharmaceuticals LP	0310-6100	0310-6100-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30)
ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350	NDA	AstraZeneca Pharmaceuticals LP	0310-6100	0310-6100-90	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Jul 31, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 30, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 31, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 30, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022350

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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