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Last Updated: January 15, 2021

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Details for New Drug Application (NDA): 021410

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NDA 021410 describes AVANDAMET, which is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the AVANDAMET profile page.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
Summary for 021410
Tradename:AVANDAMET
Applicant:Sb Pharmco
Ingredient:metformin hydrochloride; rosiglitazone maleate
Patents:1
Paragraph IV (Patent) Challenges for 021410
Tradename Dosage Ingredient NDA Submissiondate
AVANDAMET TABLET;ORAL metformin hydrochloride; rosiglitazone maleate 021410 2004-10-22

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021410

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