Last Updated: May 2, 2026

Details for New Drug Application (NDA): 021700


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NDA 021700 describes AVANDARYL, which is a drug marketed by Sb Pharmco and is included in one NDA. Additional details are available on the AVANDARYL profile page.

The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
Summary for 021700
Tradename:AVANDARYL
Applicant:Sb Pharmco
Ingredient:glimepiride; rosiglitazone maleate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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