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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. It is available from one supplier. There are five patents 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-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Summary for NDA: 021410

Tradename:
AVANDAMET
Applicant:
Sb Pharmco
Ingredient:
metformin hydrochloride; rosiglitazone maleate
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 021410

Suppliers and Packaging for NDA: 021410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL 021410 NDA Physicians Total Care, Inc. 54868-4965 54868-4965-0 60 TABLET, FILM COATED in 1 BOTTLE (54868-4965-0)
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL 021410 NDA Physicians Total Care, Inc. 54868-4965 54868-4965-1 20 TABLET, FILM COATED in 1 BOTTLE (54868-4965-1)

Summary 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1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:6,288,095*PEDPatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:7,358,366*PEDPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:8,236,345Patent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021410

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 20025,741,803*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 20025,002,953*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 20035,002,953*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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