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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 two suppliers. 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-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Summary for NDA: 200678

Tradename:
KOMBIGLYZE XR
Applicant:
Astrazeneca Ab
Ingredient:
metformin hydrochloride; saxagliptin hydrochloride
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 E.R. Squibb & Sons, L.L.C. 0003-4221 0003-4221-11 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0003-4221-11)
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200678 NDA E.R. Squibb & Sons, L.L.C. 0003-4221 0003-4221-90 1 BLISTER PACK in 1 CARTON (0003-4221-90) > 7 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:No
Patent:8,628,799Patent Expiration:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:9,339,472Patent Expiration:Jul 13, 2025Product 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


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