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 one supplier. 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. One supplier is 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021071

Ingredient-type	PPAR gamma Thiazolidinediones
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

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)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	May 25, 1999	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Oct 19, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 25, 1999	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Oct 19, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	May 25, 1999	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Oct 19, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021071

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	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	021071-003	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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