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Accenture
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Generated: June 24, 2018

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 two suppliers. There is one patent 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. Two suppliers are listed for this compound. Additional details are available on the rosiglitazone maleate profile page.
Summary for 021071
Tradename:AVANDIA
Applicant:Sb Pharmco
Ingredient:rosiglitazone maleate
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 N 0173-0861-18
AVANDIA rosiglitazone maleate TABLET;ORAL 021071 NDA GlaxoSmithKline LLC 0173-0863 N 0173-0863-13

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:May 25, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:May 25, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:May 25, 1999TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 19, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021071

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Argus Health
QuintilesIMS
Cantor Fitzgerald
Queensland Health
Fuji
UBS
Merck

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