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Last Updated: February 24, 2021

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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. There is one patent protecting this drug and two Paragraph IV challenges. 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:1
Paragraph IV (Patent) Challenges for 021700
Tradename Dosage Ingredient NDA Submissiondate
AVANDARYL TABLET;ORAL glimepiride; rosiglitazone maleate 021700 2008-05-30
AVANDARYL TABLET;ORAL glimepiride; rosiglitazone maleate 021700 2006-12-22

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 23, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021700

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-001 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-005 Mar 30, 2007   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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