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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. There are sixteen tentative approvals for this compound. Additional details are available on the rosiglitazone maleate profile page.

Summary for NDA: 021071

Tradename:
AVANDIA
Applicant:
Sb Pharmco
Ingredient:
rosiglitazone maleate
Patents:2
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: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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:May 25, 1999TE:ABRLD:No
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;ORAL021071-002May 25, 19995,002,953*PED► subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,002,953*PED► subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 19995,741,803*PED► subscribe
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