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Cantor Fitzgerald
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021071

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NDA 021071 describes AVANDIA, which is a drug marketed by Sb Pharmco and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the AVANDIA profile page.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rosiglitazone maleate profile page.

Summary for NDA: 021071

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021071

Suppliers and Packaging for NDA: 021071

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVANDIA
rosiglitazone maleate
TABLET;ORAL 021071 NDA GlaxoSmithKline LLC 0173-0861 0173-0861-18 60 TABLET, FILM COATED in 1 BOTTLE (0173-0861-18)
AVANDIA
rosiglitazone maleate
TABLET;ORAL 021071 NDA GlaxoSmithKline LLC 0173-0863 0173-0863-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0863-13)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:May 25, 1999TE:ABRLD:Yes
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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:May 25, 1999TE:ABRLD:Yes
Patent:6,288,095*PEDPatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021071

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,741,803*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 19995,002,953*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 19995,741,803*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,002,953*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 19995,741,803*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Merck
US Army
Baxter
Boehringer Ingelheim
Dow
Moodys
UBS
Cipla
Mallinckrodt
Covington

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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