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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 four suppliers. There are two patents 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 fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

Summary for NDA: 022350

Tradename:
ONGLYZA
Applicant:
Astrazeneca Ab
Ingredient:
saxagliptin hydrochloride
Patents:2
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 E.R. Squibb & Sons, L.L.C. 0003-4214 0003-4214-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-4214-11)
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL 022350 NDA E.R. Squibb & Sons, L.L.C. 0003-4214 0003-4214-21 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-4214-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2009TE:RLD:No
Patent:7,951,400Patent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:May 24, 2016
Regulatory Exclusivity Use:ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN COMBINATION WITH METFORMIN ANDA SULFONYLUREA ADDED TO THE LABELING
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES


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