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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 fourteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.

Summary for NDA: 021700

Tradename:
AVANDARYL
Applicant:
Sb Pharmco
Ingredient:
glimepiride; rosiglitazone maleate
Patents:1
Formulation / Manufacturing:see details

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:7,358,366*PEDPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:7,358,366*PEDPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:7,358,366*PEDPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021700

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDARYL
glimepiride; rosiglitazone maleate
TABLET;ORAL021700-001Nov 23, 20055,002,953*PED► subscribe
Sb Pharmco
AVANDARYL
glimepiride; rosiglitazone maleate
TABLET;ORAL021700-004Mar 30, 20075,002,953*PED► subscribe
Sb Pharmco
AVANDARYL
glimepiride; rosiglitazone maleate
TABLET;ORAL021700-003Nov 23, 20055,741,803*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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