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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200678

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NDA 200678 describes KOMBIGLYZE XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KOMBIGLYZE XR profile page.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Summary for NDA: 200678

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 200678

Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 200678

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 0310-6125-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60)
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 0310-6125-92 1 BLISTER PACK in 1 CARTON (0310-6125-92) > 12 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 5MG BASE
Approval Date:Nov 5, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 27, 2020
Regulatory Exclusivity Use:
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
Patent:► SubscribePatent Expiration:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Colorcon
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Dow
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Fish and Richardson

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