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Last Updated: September 26, 2023

Details for New Drug Application (NDA): 021071

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NDA 021071 describes AVANDIA, which is a drug marketed by Woodward and is included in one NDA. 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. Additional details are available on the rosiglitazone maleate profile page.

Summary for 021071

Tradename:	AVANDIA
Applicant:	Woodward
Ingredient:	rosiglitazone maleate
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	May 25, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 25, 1999	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 25, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021071

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

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Serving leading biopharmaceutical companies globally:

McKinsey

Medtronic

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Dow

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