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Last Updated: March 28, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022350
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:DISCNDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022350

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

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